Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
A Study of NDI 1150-101 in Patients With Solid Tumors
This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose
(RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and
preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with
pembrolizumab in adult patients with advanced solid tumors.
Hamid Emamekhoo, M.D.
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05128487
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
• Life expectancy of ≥ 12 weeks
• Measurable or non-measurable disease for Dose Escalation; measurable disease using
RECIST v1.1 is required for Dose Expansion
• Recovered from prior therapy to Grade ≤ 1 or return to baseline status (except for
alopecia)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Patients with adequate bone marrow, kidney and liver function
• Last dose of previous anticancer therapy ≥ 4 weeks prior to first dose of NDI-101150;
includes prior anti-PD-1 or anti-PD-L1 therapy, other anticancer therapy,
radiotherapy, or surgical intervention
• For Dose Escalation Phase Only (Dose Escalation, Monotherapy and Combination Therapy):
Histologically or cytologically confirmed advanced or metastatic solid tumors for whom
no standard therapies are available or refractory to standard therapy
• For Dose Expansion Phase (Dose Expansion, Monotherapy and Combination Therapy):
Willing to consent to required tumor biopsy(ies). Histologically or cytologically
confirmed advanced or metastatic G/GEJ, NSCLC or RCC for which no standard therapy is
available or are refractory to standard therapy
Key
Exclusion Criteria:
• Previous solid organ or hematopoietic cell transplant
• Central nervous system (CNS) malignant disease not previously treated, active
leptomeningeal disease, uncontrolled symptomatic CNS involvement, or CNS malignant
disease requiring steroid or other therapeutic intervention
• Prior anticancer therapy within 2-6 weeks of trial start (depending on nature of
therapy).
• Clinically significant cardiovascular disease
• History of severe hypersensitivity reaction to treatment with monoclonal antibody(ies)
(for combination therapy cohorts only)
• History of interstitial lung disease, idiopathic pulmonary fibrosis, pneumonitis
(including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans,
cryptogenic organizing pneumonia, etc.), or evidence of history of pneumonitis on
chest computed tomography scan in the last 6 months
• Known additional malignancy that is active and/or in progression requiring treatment
• Unstable or severe uncontrolled medical condition (e.g., unstable cardiac function,
unstable pulmonary condition, uncontrolled diabetes, thromboembolic event within the
past 3 months) or any important medical or psychiatric illness or abnormal laboratory
finding
• Unable to discontinue medications that are strong inducers or inhibitors of CYP3A4
and/or CYP2C8
• History of severe irAE that led to permanent discontinuation of prior immunotherapy
• History of recent Grade >/= 3 irAE or any Grade 4 life-threatening irAE, neurologic or
ocular AE of any grade while receiving prior immunotherapy
NOTE: Other protocol defined Inclusion and Exclusion criteria may apply.
Solid Tumor, Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Brain and Nervous System, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Sarcoma, Uterus
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
This is a randomized, open-label study of Serplulimab plus chemotherapy
(Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously
untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
- Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Toby Campbell, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05468489
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
Voluntary participation in clinical studies.
Male or female aged ≥ 18 years at the time of signing the ICF.
Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans
Administration Lung Study Group staging system).
No prior systemic therapy for ES-SCLC.
At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to
randomization.
Major organs are functioning well.
Every effort should be made to provide tumor tissues for the determination of PD-L1
expression.
An ECOG PS score of 0 or 1.
An expected survival ≥ 12 weeks.
Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy
for bone metastases starting prior to randomization and throughout treatment.
Participant must keep contraception.
Exclusion Criteria:
Histologically or cytologically confirmed mixed SCLC.
Known history of severe allergy to any monoclonal antibody.
Known hypersensitivity to carboplatin or etoposide.
Patients with myocardial infarction within half a year before the first dose of the study
drug, poorly controlled arrhythmia.
Pregnant or breastfeeding females.
Patients with a known history of psychotropic drug abuse or drug addiction.
Patients who have other factors that could lead to the early termination of this study
based on the investigator's judgment.
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
This study is an open-label, international, multi-center, Phase 1 study in adult patients
with solid tumors likely to express CLDN18.2.
Nataliya Uboha, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05980416
Show full eligibility criteria
Hide eligibility criteria
Key
Inclusion Criteria:
• Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)
• Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as
gastric/GEJ, pancreatic and esophageal cancer
• ≥ 18 years of age
• ECOG performance status (PS) 0 or 1 at Screening
• Progressed on or after standard therapy, or are intolerable for available standard
therapy, or there is no available standard therapy
• Have at least one measurable extra-cranial lesion as defined by RECIST v1.1
• Adequate organ function
• Life expectancy > 12 weeks
• Ability to understand the nature of this study, comply with protocol requirements, and
give written informed consent
• Willingness of men and women of reproductive potential to observe conventional and
effective birth control for the duration of treatment and for 3 months following study
completion
Key
Exclusion Criteria:
• Pregnant or breastfeeding
• Symptomatic or untreated brain metastases
• Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC
containing an auristatin payload (prior monoclonal antibody against CLDN18.2 may be
eligible)
• Have peripheral neuropathy Grade ≥2
• Have history of non-infectious pneumonitis/interstitial lung disease
• Have diagnosis of another malignancy, or history of systemic treatment for invasive
cancer within last 3 years. Note: Patients with Stage I cancer who have received
definitive local treatment and are considered unlikely to recur are eligible.
Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or
noninvasive tumor does not affect eligibility
• Have active ocular surface disease at baseline (based on screening ophthalmic
examination)
• Have serious concurrent illness or clinically relevant active bacterial, fungal or
viral infection
• Have previous hypersensitivity to any known components of EO-3021 or history of severe
infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal
antibody treatment
• Clinically significant cardiac disease, including but not limited to symptomatic
congestive heart failure, unstable angina, acute myocardial infarction within 6 months
of planned first dose, or unstable cardiac arrhythmia requiring therapy (including
torsades de pointes)
• Have history of allogenic hematopoietic stem cell transplantation or solid organ
transplantation with ongoing systemic immunosuppressive therapy
• Patients who are not appropriate candidates for participation in this clinical study
for any other reason as deemed by the Investigator
Pancreas Neoplasm, Stomach Neoplasm, Gastrointestinal Neoplasms, Digestive System Neoplasm, Neoplasms by Site, Neoplasms, Lip, Oral Cavity and Pharynx, Esophagus, Colon, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Melanoma, Skin, Kaposi's Sarcoma, Breast, Cervix, Corpus Uteri, Other Female Genital, Other Male Genital, Kidney, Eye and Orbit, Brain and Nervous System, Other Endocrine System, Ill-Defined Sites, Anal, Brain/Central Nervous System, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Melanoma/Skin cancer, Ovary, Sarcoma, Uterus
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the safety, tolerability, and efficacy of
IDE161.
Mark Burkard, MD, PhD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT05787587
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Adult participants must be 18 years of age or older
2. Advanced or metastatic solid tumors excluding primary central nervous system (CNS)
tumors
3. Have documented evidence of genetic alterations conferring homologous recombination
deficiency
4. Participant must have progressed on at least one prior line of therapy in the advanced
or metastatic setting that is considered an appropriate standard of care, or for which
the participant has documented intolerance
Exclusion Criteria:
1. Known primary CNS malignancy
2. Impairment of GI function or GI disease that may significantly alter the absorption of
IDE161
3. Have active, uncontrolled infection
4. Clinically significant cardiac abnormalities
5. Major surgery within 4 weeks prior to enrollment
6. Radiation therapy within 2 weeks prior to enrollment
7. Systemic cytotoxic chemotherapy within 4 weeks prior to enrollment
8. Radioimmunotherapy within 6 weeks of enrollment
9. Treatment with a therapeutic antibody within 4 weeks prior to enrollment
10. Treatment with an anti-cancer small molecule within 5 half-lives (t1/2), or 2 weeks,
whichever is shorter
Lip, Oral Cavity and Pharynx, Esophagus, Stomach, Small Intestine, Colon, Rectum, Anus, Liver, Pancreas, Other Digestive Organ, Larynx, Lung, Other Respiratory and Intrathoracic Organs, Bones and Joints, Soft Tissue, Melanoma, Skin, Kaposi's Sarcoma, Mycosis Fungoides, Other Skin, Breast, Cervix, Corpus Uteri, Ovary, Other Female Genital, Prostate, Other Male Genital, Urinary Bladder, Kidney, Other Urinary, Eye and Orbit, Thyroid, Other Endocrine System, Unknown Sites, Ill-Defined Sites, Any Site, Anal, Bladder, Colon and Rectum, Endocrine cancers, Gastrointestinal cancers, other, Genitourinary cancers, other, Head and Neck, Hematologic cancers, other, Melanoma/Skin cancer, Sarcoma, Uterus, Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer
Correlating Early FDG PET/CT and ctDNA in Immune Checkpoint Inhibitor (ICI)-Treated Melanoma Patients
The purpose of this research study is to determine if analysis of PET/CT scans and testing of
blood samples in people with melanoma that has spread in their body can help researchers
determine which patients are more or less likely to respond to immunotherapy and are more or
less likely to have side effects. 24 participants will be enrolled and be on study until
approximately 4 weeks after their first dose of Immune Checkpoint Inhibitor therapy.
Vincent Ma, MD
All
18 Years and over
IV
This study is NOT accepting healthy volunteers
NCT06199713
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Willing to provide informed consent.
• Must have a metastatic melanoma diagnosis (stage IV) for which treatment with
ipilimumab, nivolumab, and/or pembrolizumab, either alone or in combination with other
ICI therapy, is planned.
• Must be planning to participate in Signatera™ (ctDNA level) monitoring with standard
of care laboratory testing routinely obtained for treatment with ICI therapy.
• Individuals at least 18 years of age.
• Women of childbearing potential must be willing to use effective contraception as
discussed with their oncologist while participating in this study.
• Willing to comply with all study procedures and be available for the duration of the
study.
Exclusion Criteria:
• Not able to receive treatment with ICI therapy
• Use of investigational drugs, biologics, or devices within 30 days prior to
enrollment.
• Women who are pregnant, lactating, or planning on becoming pregnant during the study.
• Not suitable for study participation due to other reasons at the discretion of the
investigators.
Melanoma, Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma, Melanoma, Skin, Other Skin, Melanoma/Skin cancer
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
A study to assess the safety and efficacy of K-321 in participants with FECD after
simultaneous cataract surgery and descemetorhexis.
Evan Warner
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05826353
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Is at least 18 years old at the screening visit (Visit 1)
• Has a diagnosis of FECD at Visit 1
• Meet all other inclusion criteria outlined in the Clinical Study Protocol.
Exclusion Criteria:
• Is a female subject of childbearing potential and any of the following is true:
1. is pregnant or lactating/breastfeeding, or
2. is not surgically sterile, not post-menopausal (no menses for the previous 12
months), or not practicing an effective method of birth control as determined by
the Investigator (eg, oral contraceptives, double barrier methods, hormonal
injectable or implanted contraceptives, tubal ligation, or partner with
vasectomy)
• Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT)
to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by
immunotherapy with durvalumab) versus standard treatment alone in treating patients with
non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special
equipment to position a patient and deliver radiation to tumors with high precision. This
method may kill tumor cells with fewer doses over a shorter period and cause less damage to
normal tissue. IGRT is a type of radiation that uses a computer to create picture of the
tumor, to help guide the radiation beam during therapy, making it more accurate and causing
less damage to healthy tissue. Standard chemotherapy used in this trial consists of
combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and
etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It
works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of
medications known as platinum-containing compounds. It works in a way similar to the
anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by
killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of
medications called antimicrotubule agents. It works by stopping the growth and spread of
tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents.
It works by blocking the action of a certain substance in the body that may help tumor cells
multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It
blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells.
Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere
with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of
IGRT with chemotherapy and immunotherapy may be more effective at treating patients with
inoperable non-small cell lung cancer than giving the standard treatment alone.
Andrew Baschnagel, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05624996
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Pathologically (histologically or cytologically) proven diagnosis of stage II or III
(American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer
(NSCLC) with known PD-L1 status prior to registration
• Patients must have an identified primary tumor and at least one nodal metastasis
(peribronchial/hilar/intrapulmonary, mediastinal/subcarinal,
supraclavicular/scalene)
• Up to 4 cycles of systemic therapy received prior to registration for the current
study cancer is allowable; any prior chemotherapy for a different cancer is also
permissible
• The patient must be deemed clinically appropriate for curative intent definitive
combined modality therapy, based on the following staging assessments:
• History/physical examination prior to registration;
• Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the
brain (if available, contrast is preferred for all neuroimaging) prior to
registration;
• CT chest with IV contrast (if contrast is available and unless contraindicated,
such as for abnormal kidney function) prior to registration. PET/CT may be used
if the CT portion is of identical diagnostic quality as achieved in a stand-alone
CT
• No evidence of distant metastases based on FDG PET/CT scan obtain within 60 days of
registration
• Primary tumor =< 7 cm
• Age >= 18
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the
discretion of the treating physician, to allow for treatment with chemotherapy and
concurrent radiation therapy
• Creatinine clearance >= 25 mL/min by the Cockcroft-Gault (C-G) equation
• Subjects with non-malignant pleural effusion are eligible provided the effusion is not
known or demonstrated to be an exudative effusion
• If a pleural effusion is present, the following criteria must be met to exclude
malignant involvement:
• When pleural fluid is visible on both the CT scan and on a chest x-ray, a
pleuracentesis is required to confirm that the pleural fluid is
cytologically negative;
• Effusions that are minimal (i.e., not visible on chest x-ray) that are too
small to safely tap are eligible
• Medical history consistent with the patient being amenable, at the discretion of the
treating physician, to allow for treating with consolidation immunotherapy. Patients
with known EGFR/ALK mutation at the time of registration are eligible, and these
patients can be treated with consolidation durvalumab or chemotherapy at the
discretion of the treating physician
• Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen
• Negative pregnancy test =< 14 days prior to registration for participants of
childbearing potential
• The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
• Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields that is determined by the treating physician to impede the
treatment of the study malignancy
• Patients without identifiable primary tumor and at least 1 pathologically enlarged
lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1
radiographically-involved lymph node is required, but pathologic confirmation of
involvement is not mandated
• Centrally located primary tumor < 2 cm from involved nodal disease which would result
in significant overlap of the primary SBRT and nodal radiation fields. Centrally
located is defined as within or touching the zone of the proximal bronchial tree,
which is a volume 2 cm in all directions around the proximal bronchial tree (carina,
right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus,
right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi)
• Participants who are pregnant or unwilling to discontinue nursing
• Participants of childbearing potential (participants who may become pregnant or who
may impregnate a partner) unwilling to use highly effective contraceptives during
therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe
required after the final dose of the selected chemotherapy regimen, because the
treatment in this study may be significantly teratogenic
Lung, Locally Advanced Lung Non-Small Cell Carcinoma, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of
alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid
endometrial cancers by estimating the objective response rate (ORR). Treatment will continue
until either unacceptable toxicity, progression of disease, or investigator/patient request
for withdrawal.
Janelle Sobecki, MD
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT05154487
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent
endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy.
Histologic confirmation of recurrent disease is required. For cases of persistent
disease, histologic confirmation of the primary disease with radiologic evidence of
progression is required.
2. Patients must have endometrioid histology (all grades allowed) based on hysterectomy
or biopsy specimen and have positive expression of ER and oncogenic PIK3CA mutation
per criteria below.
a. PIK3CA mutations considered oncogenic include R88Q, N345K, C420R, E542K, E545X,
Q546X, M1043I, H1047X, or G1049R. The list of oncogenic mutations acceptable for
enrollment may be expanded as further information becomes available.
i. Oncogenic PIK3CA mutations identified on tests performed by the labs listed on
https://ecog-acrin.org/nci-match-eay131-designated-labs will be considered confirmed
for the purposes of this study ii. Oncogenic PIK3CA mutations identified by other
tests will need to be confirmed by the study prior to enrollment b. Estrogen receptor
(ER) status will be considered positive if ≥1% of tumor cells demonstrate positive
nuclear staining by immunohistochemistry. Pathology report documenting ER status must
be provided at enrollment.
Sites are required to report results of previous MMR and/or MSI status testing in
Medidata Rave if available.
3. All patients must have measurable disease. Measurable disease is defined by RECIST
version 1.1. Measurable disease is defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded). Each
lesion must be greater than or equal to 10mm when measured by CT, MRI or caliper
measurement by clinical exam; or greater than or equal to 20mm when measured by chest
x-ray. Lymph nodes must be greater than or equal to 15mm in short axis when measured
by CT or MRI.
Patients must have at least one "target lesion" to be used to assess response on this
protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be
designated as "non-target" lesions unless progression is documented or a biopsy is
obtained to confirm persistence at least 90 days following completion of radiation
therapy.
4. Prior chemotherapy in the adjuvant setting for Stage I, II, or III is permitted. Prior
chemoradiotherapy for a pelvic recurrence is permitted.
Note: No prior chemotherapy in the setting of Stage IV disease is permitted unless the
patient was without evidence of disease at the completion of chemotherapy and had a
least six months of progression-free survival since the completion of chemotherapy.
Regardless of circumstances, no more than one prior chemotherapy regimen (including
chemo-radiotherapy) is permitted.
Patients who received prior chemotherapy must have recovered (Common Terminology
Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy
except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A
washout period of at least 21 days is required between last chemotherapy dose and
initiation of therapy.
Patients who received radiotherapy must have completed and fully recovered from the
acute effects of radiotherapy. A washout period of at least 14 days is required
between end of radiotherapy and initiation of therapy.
5. Patient must be able to swallow oral medications.
6. Patient must have an ECOG performance status of 0 to 1.
7. Patients must have adequate glucose control as defined by the following (both criteria
must be met):
• Fasting blood glucose (FBG) ≤140/dL (7.7mmol/L) AND
• Hemoglobin A1c (HbA1c) ≤6.4%
8. Patients must have adequate organ and marrow function as defined below NOTE:
Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower
limit of normal = LLN
Bone marrow function:
• Absolute neutrophil count (ANC) greater than or equal to 1500/mcl
• Platelets greater than or equal to 100,000 cells/mcl
• Hemoglobin greater than or equal to 8 g/dL (Patients may receive erythrocyte
transfusions to achieve this hemoglobin level at the discretion of the
investigator. Initial treatment must not begin earlier than the day after
erythrocyte transfusion).
Renal function:
• Creatinine Clearance ≥ 35 mL/min using Cockcroft-Gault formula
Pancreatic function:
• Fasting Serum amylase ≤ 2 × ULN
• Fasting Serum lipase ≤ ULN
Hepatic function:
• Bilirubin less than or equal to 1.5 x ULN (Patients with Gilbert's syndrome with
a total bilirubin ≤2 times ULN and direct bilirubin within normal limits are
permitted).
• ALT (alanine aminotransferase) and AST (aspartate aminotransferase) less than or
equal to 3 x ULN
• Alkaline phosphatase less than or equal to 2.5 x ULN
• Albumin greater than or equal to 2.8 g/dL
9. Patients must have signed an approved informed consent and authorization permitting
release of personal health information.
10. Patients must be at least 18 years of age.
11. Patients of childbearing potential must have a negative serum pregnancy test prior to
the study entry and be practicing a highly effective form of contraception during the
study treatment and for 8 weeks after stopping the treatment.
Highly effective contraception methods include combination of any of the following (oral,
injected, or implanted hormonal contraceptives are prohibited:
• Placement of an intrauterine device (IUD) or intrauterine system (IUS);
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault
caps) with spermicidal foam/gel/film/cream/vaginal suppository;
• Total abstinence or;
• Male/female sterilization. Women are considered post-menopausal and not of
child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea
with an appropriate clinical profile (e.g. age appropriate, history of vasomotor
symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy)
or tubal ligation at least six weeks prior to randomization. In the case of
oophorectomy alone, only when the reproductive status of the woman has been confirmed
by follow up hormone level assessment is she considered not of child-bearing
potential.
Exclusion Criteria:
1. Patients who have previously received any PIK3CA, PI3K, mTOR, or AKT inhibitor.
2. Patients with clear cell, serous, carcinosarcoma, mixed histology endometrial cancers,
or uterine sarcomas.
3. Known intolerance or hypersensitivity to alpelisib or fulvestrant, or any of their
excipients.
4. Patients who have previously received hormonal therapy for endometrial cancer.
5. Participant has had major surgery within 14 days prior to study treatment start and/or
has not recovered from major side effects.
6. Participant with an established diagnosis of diabetes mellitus type I or uncontrolled
type II (based on fasting blood glucose [FBG] and HemoglobinA1c [HbA1c], see INCLUSION
CRITERION 7)
7. Patients with concomitant invasive malignancy or a history of other invasive
malignancies, with the exception of non-melanoma skin cancer, are excluded if there is
any evidence of other malignancy being present within the past five years. Patients
are also excluded if their previous cancer treatment contraindicates this protocol.
8. Patients with active bacterial infection (requiring intravenous [IV] antibiotics at
time of initiating study treatment, fungal infection, or detectable viral infection
(such as known human immunodeficiency virus (HIV) positivity or with known active
hepatitis B or C [for example, hepatitis B surface antigen positive]). Screening is
not required for enrollment.
9. Patients with a serious pre-existing medical condition(s) that would preclude
participation in this study (for example: interstitial lung disease or pneumonitis,
severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (i.e.
estimated creatinine clearance <30ml/min), history of major surgical resection
involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative
colitis or pre-existing chronic condition resulting in baseline grade 2 or higher
diarrhea).
10. Patients with a known history of cardiac disease. This includes:
• Uncontrolled hypertension, defined as systolic greater than 150mm Hg or diastolic
greater than 90mm Hg despite antihypertensive medications
• Myocardial infarction, unstable angina, symptomatic pericarditis, or coronary
artery bypass graft (CABG) within 6 months prior to registration.
• New York Heart Association (NYHA) Class II or greater congestive heart failure.
• History of clinically significant cardiac arrhythmias (i.e. ventricular
tachycardia or ventricular fibrillation, complete left bundle branch block, high
grade AV block (e.g. bifascicular block, Mobitz type II and third degree AV block
without pacemaker in place) or serious cardiac arrhythmia requiring medication.
This does not include asymptomatic atrial fibrillation with controlled
ventricular rate.
• Long QT syndrome, family history of idiopathic sudden death or congenital long QT
syndrome, or Fridericia QT correction formula (QTcF) > 470 msec at screening.
• Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6
months prior to the first date of study therapy.
• Syncope of cardiovascular etiology,
• Sudden cardiac arrest.
11. Participant is currently receiving any of the following medications and cannot be
discontinued 7 days prior to the start of the treatment:
• Strong CYP3A4 inducers
• Inhibitors of BCRP.
12. Patients who are pregnant or breast-feeding.
13. Patients with known central nervous system metastases which was not previously treated
and not fulfilling the following 3 criteria to be eligible for the study:
• Completed prior therapy (including radiation and/or surgery) for CNS metastases ≥
28 days prior to the start of study entry and
• CNS tumor is clinically stable at the time of screening and
• Participant is not receiving steroids and/or enzyme inducing anti-epileptic
medications for brain metastases.
14. Patients with an impairment of gastrointestinal function or gastrointestinal disease
that may significantly alter the absorption of the study drugs (i.e. ulcerative
disease; uncontrolled nausea, vomiting and/or diarrhea; malabsorption syndrome;
clinical signs and symptoms of gastrointestinal obstruction; and/or patients who
require parenteral hydration and/or nutrition).
15. Patients who plan to receive live attenuated vaccines within 1 week of start of
alpelisib and during the study. Patients should also avoid close contact with others
who have received live attenuated vaccines. Examples of live attenuated vaccines
include intranasal influenza, measles, mumps, rubella, oral polio, BCG< yellow fever,
varicella, and TY21a typhoid vaccines.
16. Patients with active bleeding or pathologic conditions that carry high risk of
bleeding such as known bleeding disorder or coagulopathy.
17. Patients who are currently part of or have participated in any clinical investigation
with an investigational drug within 30 days prior to dosing, or within 5 half-lives of
the investigational product, whichever is longer.
18. Patient is not able to understand and to comply with study instructions and
requirements, including oral administration of study treatment.
Endometroid Endometrial Cancer, Corpus Uteri, Uterus
A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of CFT1946 as well as to
determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of
CFT1946 as monotherapy (Arm A) and in combination with trametinib (CFT1946 + trametinib; Arm
B) or Cetuximab (CFT1946 + cetuximab; Arm C).
Vincent Ma, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT05668585
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Subject (or legally authorized representative, where applicable) is willing and able
to provide signed informed consent and can follow protocol requirements
2. Subject is ≥18 years of age at time of informed consent
3. Eastern Cooperative Oncology Group performance status of 0 or 1
4. Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or
liquid biopsy: (other protocol conditions may apply)
5. Subject must have received ≥1 prior line of SoC therapy for their unresectable locally
advanced or metastatic disease with disease progression on or after last prior
treatment. Prior regimens for these subjects vary by indication and investigational
arm, but must have included the following:
1. Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF
inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior
(neo)adjuvant immunotherapy may be acceptable.
2. CRC: Subjects must have received no more than 4 lines of prior therapy which
includes systemic chemotherapy-based regimen per SoC for unresectable locally
advanced or metastatic disease, and previous treatment with BRAF inhibitor in
combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or
dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must
have received at least 2 prior treatments. Subjects who received neo(adjuvant)
chemotherapy regimens may be eligible.
3. ATC: Subjects must have received SoC therapy options including BRAF inhibitor if
available and of benefit to the subject
4. Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC
therapy options per their Investigator's best judgment, including BRAF inhibitor
if available and of benefit to the subject
6. Subject has measurable disease per RECIST v1.1
7. Adequate bone marrow, liver, renal, and cardiac function
8. A female subject may be eligible if not pregnant, planning a pregnancy, not breast
feeding, a women of non-child bearing potential or a WOCBP willing to comply with
protocol conditions relating to the use contraception, ova or blood donation and
pregnancy testing prior to the first dose
9. A male subject must agree to comply with protocol conditions relating to the use of
contraception, sperm and blood donation
10. Subject can safely swallow a tablet or pill
Other protocol defined exclusion criteria may apply
Exclusion Criteria:
1. Subject has had major surgery within 21 days prior to the planned first dose. Minor
surgery is permitted within 21 days prior to enrollment
2. Subject with CNS involvement (primary tumor or metastatic disease), except if
clinically stable, have no evidence of new or enlarging brain metastases and are on
stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects
with untreated brain metastases may be eligible to enter without prior radiation
therapy.
3. Subject with known malignancy other than trial indication that is progressing or has
required treatment within the past 3 years, except for conditions that have undergone
potentially curative therapy
4. Subject with history of thromboembolic or cerebrovascular events ≤6 months as defined
in the protocol
5. Subject with impaired cardiac function or clinically significant cardiac disease, as
defined in the protocol
6. Subject with history of uncontrolled diabetes mellitus (only for subjects who will
receive CFT1946 + trametinib)
7. Subject with history or current evidence of retinal vein occlusion (RVO),
chorioretinopathy, or current risk factors for RVO (only for subjects who will receive
CFT1946 + trametinib)
8. Subject has received live, attenuated vaccine within 28 days prior to first dose
administration
9. Subject has history of pneumonitis or interstitial lung disease
10. Subject has history of uveitis
11. Subject has clinically significant gastrointestinal abnormalities.
12. Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
13. Subject has history of or known HBV or active HCV infection
14. Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers,
including any herbal medications/supplements
15. Subject has presence of Grade ≥2 toxicity due to prior cancer therapy, excepting
alopecia and hypothyroidism requiring thyroid replacement therapy
16. Subject has initiation or receipt of the following ≤7 days prior to first dose
administration: Hematopoietic colony-stimulating growth factors, transfusion of packed
red blood cells (pRBC), and transfusion of platelets
17. Subject is pregnant, breastfeeding, or expecting to conceive or father children any
time during the study
Other protocol defined exclusion criteria may apply
Solid Tumors, Melanoma, NSCLC, CRC, ATC, Colon, Rectum, Lung, Melanoma, Skin, Thyroid, Colon and Rectum, Melanoma/Skin cancer
Testing the Combination of New Anti-cancer Drug Peposertib With Avelumab and Radiation Therapy for Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
This phase I/II trial studies the best dose and side effects of peposertib and to see how
well it works with avelumab and hypofractionated radiation therapy in treating patients with
solid tumors and hepatobiliary malignancies that have spread to other places in the body
(advanced/metastatic). Peposertib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab,
may help the body's immune system attack the cancer, and may interfere with the ability of
tumor cells to grow and spread. Hypofractionated radiation therapy delivers higher doses of
radiation therapy over a shorter period of time and may kill more tumor cells and have fewer
side effects. Giving peposertib in combination with avelumab and hypofractionated radiation
therapy may work better than other standard chemotherapy, hormonal, targeted, or
immunotherapy medicines available in treating patients with solid tumors and hepatobiliary
malignancies.
Jeremy Kratz, MD
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04068194
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• PHASE 1: Patients must have a histologically confirmed metastatic or locally advanced
unresectable solid tumor that has progressed on or after available standard of care
therapy or for which no acceptable standard of care therapy exists, or in which the
patient declines standard of care therapy (each patient that declines standard of care
therapy will be documented in the case report form)
• PHASE 2: Patients must have a histologically confirmed metastatic or locally advanced
unresectable cholangiocarcinoma/gallbladder carcinoma that has progressed on at least
1 prior standard of care therapy or for which no acceptable standard of care therapy
exists, or in which the patient declines standard of care therapy (each patient that
declines standard of care therapy will be documented in the case report form)
• Age >= 18 years
• Because no dosing or adverse event data are currently available on the use of
M3814 in combination with avelumab in patients < 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Patients with at least 1 index lesion to irradiate for whom palliative radiation
treatment is indicated (including but not limited to pain and/or symptom control,
prevention of disease -related complications, and preservation of organ function).
Lung and liver lesions are preferred, though alternate lesions may be considered after
discussion with trial principal investigator (PI). Up to 2 lesions may be considered
for irradiation provided at least 1 lesion will receive the study treatment of total
of 60 Gy and all prescribed irradiation will be completed within the radiation window
• Patients with at least 1 Response Evaluation Criteria in Solid Tumors (RECIST)
measurable lesion (to be unirradiated) (defined as those accurately measured in at
least one dimension, with the longest diameter to be recorded for non-nodal lesions
and the shortest diameter for nodal lesions). Measurable is defined as at least 10 mm
in longest diameter for solid tumors, at least 15 mm in shortest diameter for lymph
nodes
• Patients must be willing to undergo fresh biopsies at baseline (as opposed to using
archival tissue), in the event their baseline tissue was obtained > 12 months prior to
study consent and/or they are randomized to the gamma H2AX pNBS1 multiplex IFA assay
• Absolute neutrophil count (ANC) >= 1,500/mcL
• Platelet count >= 100,000/mcL
• Hemoglobin >= 9.0 g/dL
• Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated serum creatinine
clearance (glomerular filtration rate [GFR] can be used in place of creatinine or
creatinine clearance) >= 60 mL/min for participants with creatinine levels > 1.5 x
institutional ULN
• Calculate serum creatinine clearance using the standard Cockcroft-Gault formula
• Serum total bilirubin =< 1.5 x ULN or direct bilirubin =< ULN for participants with
total bilirubin > 1.5 x ULN
• Patients with known Gilbert disease with serum bilirubin level =< 3 x ULN are
eligible
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
ULN or =< 5.0 x ULN for patients with hepatobiliary tumors/liver metastases
• Albumin >= 2.8 g/L
• International normalized ratio (INR) or prothrombin time (PT) or activated partial
thromboplastin time (aPTT) =< 1.5 x ULN
• This applies only to patients not receiving therapeutic anticoagulation; patients
receiving therapeutic anticoagulation should be on a stable dose
• Participants must have the ability to swallow and retain oral medication and not have
any clinically significant gastrointestinal abnormalities that might alter absorption
• Female patients of childbearing potential must have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study medication.
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy
test will be required. The effects of M3814 and avelumab on the developing human fetus
are unknown and there is the potential for teratogenic or abortifacient effects. For
this reason, women and men of child-bearing potential must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to study
entry, for the duration of study treatment, and for 6 months after completion of M3814
and avelumab administration. Should a woman become pregnant or suspect she is pregnant
while she or her partner is participating in this study, she should inform her
treating physician immediately. Because there is an unknown but potential risk for
adverse events in nursing infants secondary to treatment of the mother with M3814 and
avelumab, breastfeeding should be discontinued if the mother is treated with M3814 and
avelumab
• Ability to understand and the willingness to sign a written informed consent document.
Participants with impaired decision-making capacity (IDMC) who have a close caregiver
or legally authorized representative (LAR) and/or family member available will also be
eligible
Exclusion Criteria:
• PHASE I: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other
immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents
• PHASE II: Patients who have received prior anti-CTLA-4, anti-PD-1, anti-PD-L1 or other
immune checkpoint inhibitor therapeutic antibodies or pathway-targeting agents with
the following exceptions:
• Patients who have only received previous durvalumab (anti-PD-L1) in combination
with gemcitabine +/- cisplatin as part of first line therapy (TOPAZ-1 regimen)
are eligible
• Patients who have only received previous pembrolizumab (anti-PD-1) in combination
with gemcitabine +/- cisplatin as part of first line therapy (KEYNOTE-966
regimen) are eligible
• Patients who have had chemotherapy, definitive radiation, biological cancer therapy,
or investigational agent/device within 21 days of first planned dose of study therapy
(within 14 days for palliative radiation). Previously irradiated lesions may be
re-irradiated provided there is disease progression in the irradiated lesion and the
prescribed radiation dosage can safely be re- administered
• Patients who have not recovered from adverse events due to prior anti-cancer therapy
(i.e., have residual toxicities > Common Terminology Criteria for Adverse Events
[CTCAE] grade 1) with the exception of alopecia
• Patients with untreated/uncontrolled central nervous system (CNS)/leptomeningeal
disease. Patients with asymptomatic, treated CNS disease are eligible if the treating
physician determines that immediate CNS specific treatment is not required and is
unlikely to be required during the first cycle of therapy and the following criteria
are met:
• Radiographic demonstration of clinical stability upon the completion of
CNS-directed therapy and no evidence of interim progression between the
completion of CNS-directed therapy and the screening radiographic study done >= 4
weeks from completion of radiotherapy and >= 2 weeks from discontinuation of
corticosteroids
• No stereotactic radiation or whole-brain radiation within 28 days prior to
randomization
• Patients with active autoimmune disease requiring systemic corticosteroids greater
than the equivalent of prednisone 10 mg daily including but not limited to: systemic
lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, colitis,
vascular thrombosis associated with antiphospholipid syndrome, Wegener's
granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple
sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis, with the
following exceptions:
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid
replacement hormone are eligible
• Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are
eligible
• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with
dermatologic manifestations only who require only low potency topical steroids
(e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%,
desonide 0.05%, alclometasone dipropionate 0.05%) are eligible
• Patients receiving treatment with systemic immunosuppressive medications (including,
but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate,
thalidomide, and anti-tumor necrosis factor [TNF] agents) within 6 weeks must
discontinue these medications prior to starting M3814 and avelumab on day 7, with the
exception of:
• Patients with active autoimmune disease managed with systemic corticosteroids
less than the equivalent of prednisone 10 mg daily
• Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea)
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)
for patients with orthostatic hypotension and adrenocortical insufficiency
• Patients who have undergone prior solid organ or bone marrow transplant with the
exception of patients with prior renal transplant for whom dialysis may be employed in
the event of graft rejection
• Patients with uncontrolled intercurrent illness (e.g., including but not limited to
uncontrolled hypertension [HTN] [systolic blood pressure (BP) > 150, diastolic BP >
100], symptomatic congestive heart failure [CHF], unstable angina pectoris, ischemic
myocardial infarction [MI] within 6 months, cardiac arrhythmia, recent transient
ischemic attack [TIA or cerebrovascular accident (CVA)]) within 6 months
• Patients with serious active infection (e.g. requiring hospitalization and/or
intravenous [IV] antibiotics) within 4 weeks prior to starting M3814 and avelumab, or
signs/symptoms of infection or receiving oral or IV antibiotics for the treatment of
active systemic infection within 2 weeks prior to starting M3814 and avelumab.
Patients receiving prophylactic antibiotics are eligible
• Patients with known chronic hepatitis B virus (HBV) infection must have an
undetectable viral load on suppressive therapy if indicated. Patients with known
chronic hepatitis C (HCV) infection must have been treated and cured. Patients who are
currently on curative treatment are eligible if they have an undetectable HCV viral
load
• Patients with known human immunodeficiency virus (HIV) are allowed on study provided
they have:
• A stable regimen of highly active anti-retroviral therapy (HAART)
• No requirement for concurrent antibiotics or antifungal agents for the prevention
of opportunistic infection
• A CD4 count above 250 cells/mcL
• An undetectable HIV viral load on standard polymerase chain reaction (PCR)-based
testing
• Patients with history of idiopathic pulmonary fibrosis, pneumonitis (including drug
induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing
pneumonia), or evidence of active pneumonitis on screening chest computed tomography
(CT) scan
• Patients with known concurrent malignancy that is expected to require active treatment
within two years, or may interfere with the interpretation of the efficacy and safety
outcomes of this study in the opinion of the treating investigator. Superficial
bladder cancer, nonmelanoma skin cancers, and low-grade prostate cancer not requiring
cytotoxic therapy should not exclude participation in this trial. Patients with
chronic lymphocytic leukemia (CLL) may be enrolled if they do not require active
chemotherapy and their hematologic, renal and hepatic function meets criteria
previously mentioned
• Patients with psychiatric illness/social situations that would limit compliance with
study requirements
• History of allergic reactions attributed to compounds of similar chemical or biologic
composition to M3814 or avelumab
• Patients unable to discontinue medications or substances that are potent inhibitors,
inducers or sensitive substrates of CYP3A4/5 or CYP2C19 prior to starting M3814 and
avelumab are ineligible. Medications or substances that are strong inhibitors of
CYP3A4/5 or CYP2C19 must be discontinued at least 1 week prior to first M3814 dose.
Strong inducers of CYP3A4/5 or CYP2C19 must be stopped at least 3 weeks prior to the
first dose. Drugs mainly metabolized by CYP3A with a narrow therapeutic index as
judged by the investigator must stop at least 1 day prior to first M3814 dose. Because
the lists of these agents are constantly changing, it is important to regularly
consult a frequently-updated medical reference. As part of the enrollment/informed
consent procedures, the patient will be counseled on the risk of interactions with
other agents, and what to do if new medications need to be prescribed or if the
patient is considering a new over-the-counter medicine or herbal product. The primary
elimination mechanism of avelumab is proteolytic degradation, thus there are no
contraindicated medications with respect to avelumab
• Patients who cannot discontinue concomitant proton-pump inhibitors (PPIs) prior to
starting M3814 and avelumab. These must be discontinued >= 5 days prior to starting
M3814 and avelumab. Patients do not need to discontinue calcium carbonate. H2 blockers
are allowed provided they are taken at least 2 hours after M3814 dose
• Patients receiving sorivudine or any chemically related analogues (such as brivudine)
and not able to discontinue prior to starting M3814 and avelumab are excluded
• Pregnant and lactating women are excluded from this study because M3814 and avelumab
are agents with the potential for teratogenic or abortifacient effects. Because there
is an unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with M3814 and avelumab, breastfeeding should be discontinued
if the mother is treated with M3814 and avelumab
• Patients who have received live vaccination within 30 days before starting M3814 and
avelumab
Cholangiocarcinoma, Gallbladder Carcinoma, Stage III Gallbladder Cancer AJCC v8, Stage III Hilar Cholangiocarcinoma AJCC v8, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Hilar Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Liver, Other Digestive Organ, Gastrointestinal cancers, other
Outcomes and Cosmesis With Whole Breast Irradiation and Boost
This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and
toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with
simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.
Jessica Schuster, MD
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT06295744
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Ability to understand and the willingness to sign a written informed consent document
• Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or
DCIS
• Breast conserving surgery with negative margins and negative nodes (surgical axillary
staging not mandatory), stage N0 or Nx
• Treatment plan should include breast conserving surgery and adjuvant whole breast
irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
• Treatment plan includes breast tumor bed boost
• Willingness to comply with all study procedures and be available for the duration of
the study
Exclusion Criteria:
• Mastectomy of ipsilateral breast
• Lack of histologic diagnosis
• Histologic involvement of the axillary or regional nodes or metastatic disease
• Accelerated partial breast irradiation treatment plan
• Previous history of non-breast malignancy diagnosed in the past 5 years except for
basal or squamous cell cancer of the skin
• Previous history of chest radiation therapy
• Previous history of ipsilateral breast cancer
• Concurrent cytotoxic chemotherapy
• Active connective tissue disease including scleroderma
• Inability or unwillingness to return for required follow up visit
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)
Objectives of this study are to determine whether active VNS Therapy treatment is superior to
a no stimulation control in producing a reduction in baseline depressive symptom severity,
based on multiple depression scale assessment tools at 12 months from randomization.
Steven Garlow, MD, PhD
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03887715
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
The patient must be in a major depressive disorder (MDD) episode for ≥ two years or have
had at least four episodes of MDD, including the current episode.
The patient's depressive illness meets a minimum criterion of four prior failed treatments
of adequate dose and duration as measured by a tool designed for this purpose.
The patient is experiencing a major depressive episode (MDE) as measured by a guideline
recommended depression scale assessment tool on two visits, within a 45-day span prior to
implantation of the VNS device.
Patients must maintain a stable medication regimen for at least four weeks before device
implantation.
Exclusion Criteria:
Current or lifetime history of psychotic features in any MDE;
Current or lifetime history of schizophrenia or schizoaffective disorder;
Current or lifetime history of any other psychotic disorder;
Current or lifetime history of rapid cycling bipolar disorder;
Current secondary diagnosis of delirium, dementia, amnesia, or other cognitive disorder;
Current suicidal intent; or
Treatment with another investigational device or investigational drugs.
Treatment Resistant Depression, Bipolar disorder, Major depressive disorder, recurrent, Other
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia
This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs.
placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and
efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52
weeks in infants with genetically verified heterozygous ACH, aged 0 to < 2 years at the time
of randomization.
Janet Legare
All
0 Years to 2 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT06079398
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Written, signed informed consent by the parent(s)/caregiver(s) of the participant, and
as required by the institutional review board/human research ethics
committee/independent ethics committee (IRB/HREC/IEC).
• Male or female younger than 2 years of age at the time of randomization; or for open
label sentinel participants, at the time of first administration of IMP.
• Clinical diagnosis of achondroplasia (ACH) with genetic confirmation of heterozygous
genotype present during screening.
• Parent(s)/caregiver(s) willing to follow the protocol and instructions provided,
including being able to administer weekly subcutaneous injections of trial treatment.
• Compliance to daily Vitamin D supplementation for infants aged 14 days to 1 year. All
participants older than 1 year of age with serum 25-hydroxyvitamin D (25OHD) measured
below lower limit of reference range at screening should start daily Vitamin D
supplementation prior to randomization.
• Considered eligible based on the medical history, physical examination, and the
results of vital signs, ECG, imaging, and clinical laboratory tests performed during
the screening period.
Exclusion Criteria:
• Known or suspected hypersensitivity to the investigational product or related products
(trehalose, tris[hydroxymethyl]aminomethane, succinate, and polyethylene glycol
[PEG]).
• Genetic confirmation of ACH homozygous genotype.
• Premature birth with gestational age < 32 weeks.
• Premature birth with gestational age 32 to 37 weeks, unless time from birth is > 6
months at the time of screening and the child is in good nutritional status, defined
as gain in body weight expected for age and diagnosis of ACH, as determined by the
Investigator and confirmed with the Medical Monitor.
• Anticipated, as assessed by Investigator and confirmed with Medical Monitor, to
undergo surgical intervention during trial participation, including cervicomedullary
decompression. Evaluation of immediate risk of requiring cervicomedullary
decompression surgery will rely on the following assessments:
• Physical examination (e.g., neurologic findings of clonus, opisthotonus,
exaggerated reflexes, dilated facial veins)
• Evidence of uncontrolled sleep apnea as confirmed by local standard of care
assessment (e.g. polysomnography or simple sleep test) performed within 6 months
prior to screening.
• MRI performed at screening indicating presence of severe cervicomedullary
compression (CMC) or spinal cord damage. Presence of abnormal MRI T2 signal
intensity at and immediately above and below the cervicomedullary junction should
be considered high risk for requiring surgery and the participant is not eligible
for trial participation.
Common surgeries, such as insertion of grommets, adenoidectomy, tonsillectomy, or
myringotomy tube placement are permitted during trial participation.
• Have a growth disorder or medical condition, other than ACH, resulting in short
stature or abnormal growth as determined by the Investigator and confirmed with the
Medical Monitor.
• Have received any dose of prescription medications and/or investigational medicinal
product or device intended to affect stature, growth, or body proportionality
(including human growth hormone or vosoritide) at any time.
• Requires or anticipated to require chronic (> 4 weeks) or repeated treatment (more
than twice/year) with oral corticosteroids, or high-dose inhaled corticosteroids
during trial participation.
• History or presence of injury or disease of the growth plate(s), other than ACH,
affecting growth potential of long bones, including Salter-Harris fracture and recent
bone-related surgery, as determined by Investigator and confirmed with the Medical
Monitor.
• Have a clinically significant finding indicating abnormal cardiac function, including
but not limited to:
• Repaired or unrepaired coarctation.
• Moderate or greater complexity congenital heart disease including tetralogy of
Fallot, atrioventricular septal defects, truncus arteriosus, total anomalous
pulmonary venous return, double outlet right ventricle, or single ventricle heart
disease.
• QTcF ≥ 450 msec on screening 12-lead ECG.
• History or presence of a condition impacting hemodynamic stability (such as autonomic
dysfunction and orthostatic intolerance).
• History or presence of the following:
• Chronic anemia.
• Chronic renal insufficiency.
• Chronic or recurrent illness that can affect hydration or volume status,
including conditions associated with decreased nutritional intake or increased
volume loss.
• History or presence of malignant disease.
• Any disease or condition that, in the opinion of the Investigator, may make the
participant unlikely to fully complete the trial, not adhering to trial procedures,
may confound interpretation of trial results, or may present undue risk from receiving
trial treatment. This could include family situations, comorbid conditions, or
medications that might impact safety or be considered confounding.
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of
ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses
are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to
objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia
(iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is
superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per
iwCLL Criteria 2018 by BICR.
Christopher Fletcher, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT06136559
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
• Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to
initiate therapy.
• Has at least 1 marker of disease burden.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7
days before randomization.
• Has the ability to swallow and retain oral medication.
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they
have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have
undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV
ribonucleic acid (RNA) viral load is undetectable at screening.
• Participants with human immunodeficiency virus (HIV) who meet ALL eligibility
criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
• Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.
• Has gastrointestinal (GI) dysfunction that may affect drug absorption.
• Has diagnosis of Richter Transformation or active central nervous system (CNS)
involvement by CLL/SLL.
• Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in
the past 12 months before screening.
• Has clinically significant cardiovascular disease.
• Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or
acalabrutinib, or any of the excipients.
• Has history of severe bleeding disorder.
• Has history of second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.
• Has received any systemic anticancer therapy for CLL/SLL.
• Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow
therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A
strong inhibitors.
• Received prior radiotherapy within 2 weeks of start of study intervention, or
radiation-related toxicities, requiring corticosteroids.
• Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines are allowed.
• Has received an investigational agent or has used an investigational device within 4
weeks before study intervention administration.
• Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of
immunosuppressive therapy within 7 days prior the first dose of study medication.
• Has active autoimmune disease that has required systemic treatment in the past 2
years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is
allowed.
• Has active infection requiring systemic therapy.
• Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma
Interventions for Patients With Alzheimer's Disease and Dysphagia
The overall purpose of this project is to develop effective dysphagia rehabilitative
interventions for patients with Alzheimer's Disease and related dementias at risk for
pneumonia development.
Nicole Rogus-Pulia, PhD
All
50 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03682081
Show full eligibility criteria
Hide eligibility criteria
Inclusion criteria (patients):
• Age 50-99
• English speaking
• Diagnosis of dementia or cognitive impairment or memory loss
• Clinical Dementia Rating (CDR) scale score between 0.5 and 2.0
• Actively involved caregiver
• Resides at home, assisted living facility, or long-term care facility
Inclusion criteria (caregivers)
• English speaking
• Age 18 and older
• Contact with patient at least 1 time a week
• Has access to a working telephone
Exclusion criteria (patients):
• Dementia due to cerebrovascular disease as primary cause
• History of head and neck cancer or other structural deformity that can affect
swallowing
• Allergy to barium
• Currently breastfeed or pregnant or planning to become pregnant
Exclusion criteria (caregivers):
• Lacks ability to give consent
Dementia, Dysphagia, Alzheimer Disease, Alzheimer's disease, Aphagia and dysphagia, Dementia in other diseases classified elsewhere, Mild Cognitive Impairment, Unspecified dementia, Other, Aging & Geriatrics, Food & Nutrition
FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer
Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately
develops. A common driver of resistance are known ESR1 mutations that lead to constitutively
active receptor signaling and transcriptional regulation that is always "turned on" despite
the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding
affinity for tamoxifen and thus may be underdosed on standard therapy. [18F]-fluoroestradiol
Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional
imaging technique that can non-invasively measure ERα expression and inhibition in metastatic
ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα
blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.
Kari Wisinski, MD
All
19 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04174352
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Participants must have histologically confirmed breast cancer that is metastatic or
unresectable with the following:
• Estrogen receptor expression by immunohistochemistry greater than or equal to 10%
• ESR1 mutation identified using a Clinical Laboratory Improvement Amendments
(CLIA) certified assay via tumor biopsy tissue or circulating free DNA (cfDNA)
• human epidermal growth factor receptor 2 (HER2) negative
• Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone
disease with at least one lesion measuring 10 mm or greater in size. (Participants
with bone and non-bone disease are eligible. One disease site must meet either the
measurable or evaluable criteria outlined.) Participants with liver-only disease are
not eligible due to the inherent hepatic uptake related to the radiopharmaceutical's
hepatobiliary route of elimination.
• Participants must have received at least 1 prior line of endocrine therapy in the
metastatic setting or have had progression within 12 months of adjuvant endocrine
therapy. Prior Tamoxifen is allowed in any setting. Prior CDK4/6 in the metastatic
setting per NCCN guidelines is allowed.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (See Appendix A)
• Life expectancy of greater than 12 weeks.
• Ability to take oral medications.
• Informed consent: participant must be informed of the investigational nature of the
study and must be able to sign a written informed consent.
• Participants with central nervous system (CNS) metastases must be stable after therapy
for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at
least 1 month.
• Participants must have adequate normal organ and bone marrow function as defined
below:
• Absolute neutrophil count >/= 1,000/mcL
• Hemoglobin >/= 9.0 g/dL
• Platelets >/= 100,000/mcL
• Total bilirubin = 1.5 x upper limit of normal (ULN)
• AST (SGOT)/ ALT (SGPT) = 2.5 x ULN; = 5 x ULN in the setting of metastatic
liver disease
• Creatinine = 1.5 x ULN or creatinine clearance >/= 50 mL/min
Exclusion Criteria:
• Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy
within 2 weeks or major surgery within 4 weeks of study enrollment or those who have
not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events
due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded).
• Participants must not be receiving an ER blocking endocrine therapy (includes
fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a
minimum of 60 days prior to planned FES PET/CT to allow for adequate uptake of FES.
• History of allergic reactions attributed to compounds of chemical or biologic
composition similar to those of tamoxifen or [18F]-fluoroestradiol.
• Peripheral neuropathy of severity greater than grade 1.
• Current optic nerve disorders, retinopathy, lattice degeneration, macular
degeneration, retinal vascular disorder, or retinal tears of severity greater than
grade 1.
• History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to
transient medical condition and in investigator's opinion is not an active medical
issue.
• History of venous thrombosis/thromboembolic event, including pulmonary embolism and
stroke.
• Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec
or other factors that increase the risk of QT prolongation or arrhythmic events (e.g.,
heart failure, chronic hypokalemia, family history of long QT interval syndrome).
• Are taking medications that are known to prolong the QT interval, unless they can be
transferred to other medications ≥ 5 half-lives prior to dosing or unless the
medications can be properly monitored during the study. If equivalent medication is
not available, QTcF should be closely monitored.
• Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant
women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus
of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential
(WOCP) must not be pregnant (confirmed by a negative urine/serum pregnancy test within
14 days of tamoxifen treatment). In addition, a medically acceptable method of birth
control must be used such as an intrauterine device (IUD), use of a double barrier
method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or
cream), or total abstinence during the study participation and for 3 months after last
dose of study drug. Women who are postmenopausal for at least 1 year or surgically
sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not
considered to be WOCP.
• Ongoing treatment with other investigational agents. Participants cannot be receiving
concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not
otherwise outlined by the trial for the purposes of anti-cancer treatment.
• History of uterine malignancy unless participant has had hysterectomy with no evidence
recurrent disease for ≥ 3 years from definitive therapy.
• Concurrent malignancy except for the following:
• Basal cell or squamous cell skin cancer
• In situ cervical cancer
• The following medications are contraindicated or must be used with caution.
• Contraindicated:
• CYP2D6, CYP3A4, and CYP2C9 strong inhibitors
• CYP2D6, CYP3A4, and CYP2C9 strong inducers
• Use with caution:
• CYP2C9 sensitive substrates
• CYP2D6 moderate inhibitors or inducers
• CYP3A4 moderate inhibitors or inducers
Note: Transdermal products designed for systemic delivery must be assessed for interaction
potential. Topical products not designed to provide systemic delivery (including inhaled
products, ophthalmologic products and transvaginal preparations) do not need to be
considered.
Contraindicated medications are not allowed. Participants taking these concurrent
medications are ineligible unless they can discontinue or switch to alternative medications
prior to initiation of study drug (at least 5 half-lives).
Use with caution agents are permitted if a) discontinuation is not feasible or b) no
acceptable alternatives are available as determined by the treating physician; however,
caution should be used. Consider monitoring by symptoms, labs or drug levels and dose
adjustments of the medication.
• Uncontrolled intercurrent clinically significant illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements.
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology
The purpose of this research is to determine if functional muscle stimulation, directed by
electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral
measures and induce brain plasticity as measured by functional magnetic resonance imaging
(fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect
to be on study for approximately 4 months.
Vivek Prabhakaran
All
50 Years to 85 Years old
N/A
This study is also accepting healthy volunteers
NCT04141774
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• New-onset ischemic stroke 12 months prior •chronic time frame;
• Right hand dominant •affected arm;
• Mild to moderate unilateral upper extremity impairment or severe unilateral upper
extremity impairment;
• No upper extremity injury or conditions that limited use prior to the stroke;
• Must be able to provide informed consent on their own behalf.
Exclusion Criteria:
• Inability to competently participate in study procedures
• Concurrent upper extremity therapy, other neurological or psychiatric disorders
Stroke, Transient cerebral ischemic attacks and related syndromes, Other
Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects
physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments
exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal
high-resolution manometry (pHRM) directly measures swallowing pressures, providing an
objective measurement of physiology that characterizes the basic mechanisms of swallowing.
pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective,
and reproducible measures of swallowing function.
This proposed project will address a central hypotheses that objective swallowing measures
(including (pHRM) will reveal treatment-mediated swallowing changes, will align with
patient-reported outcome measures, and will be able to predict who will benefit from
treatment. The investigators will follow a cohort of participants with oropharyngeal
dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper
esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6
weeks) and post-treatment (10-12 weeks). The investigators will compare participants to
healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and
patient-reported outcome measures.
Timothy Mcculloch, MD
All
18 Years to 99 Years old
NA
This study is also accepting healthy volunteers
NCT04130867
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Pathological Group
• Must have dysphagia as diagnosed by a licensed and certified otolaryngologist,
gastroenterologist, or speech-language pathologist AND must have a dysphagia
treatment plan that includes one of the following primary goals:
• Therapy to strengthen oropharyngeal musculature
• Medical or surgical management to relieve an obstruction at the upper
esophageal sphincter
• Must agree to comply with swallowing assessment, including interview and
manometry
• Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin
• Normal Group
• Having no swallowing disorders
• Must agree to comply with swallowing assessment, including interview and
manometry
• Must sign the Informed Consent form approved by the Health Sciences Institutional
Review Board of the University of Wisconsin.\
Exclusion Criteria:
• Pathological Group
• Therapeutic management plan already initiated prior to recruitment
• Therapy goals including only improvement of swallowing coordination
• Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
• Positive history of allergic response to topical anesthetic
• Allergy to food relevant to study participation (e.g. lactose intolerance)
• Normal Group
• Known swallowing disorder
• Developmental disability, dementia, cognitive dysfunction, or difficulty
comprehending instructions
• Positive history of allergic response to topical anesthetic
• Allergy to food relevant to study participation (e.g. lactose intolerance)
This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30
Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no
more than 5 years prior, with a history of tremors following transplantation.
Jon Odorico, MD
All
18 Years to 70 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT03769298
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Adult, 18-70 years of age
• Participant must be able to understand and provide consent
• History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney
Disease (CKD)
• Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to
screening, per Principal Investigator's discretion.
• Have a history of tremors following transplantation
• Stable pancreas allograft function as evidenced by no requirement of exogenous insulin
or oral anti-diabetic agents and stable pancreatic enzymes
• Stable kidney allograft function
• Currently taking Immediate-Release (IR) tacrolimus
• Women of child-bearing potential (WOCP) must have a negative pregnancy test at the
time of study entry
Exclusion Criteria:
• Currently maintained on an extended-release tacrolimus immunosuppressive regimen
• Previous history of tremors prior to transplantation
• Solitary pancreas transplant recipients
• History of solid organ transplant other than a kidney or pancreas
• Uncontrolled concomitant infection at the discretion of the investigator
• Presence of Donor Specific Antibodies
Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the
combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for
HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and
Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will
be better tolerated than current first-line chemotherapy combinations for this disease.
Nataliya Uboha, MD
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04150640
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Written informed consent and HIPAA authorization for release of personal health
information.
NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2
status prior to treatment initiation required. Known PDL1 CPS status prior to
treatment initiation.
• Measurable disease according to RECIST v1.1.
• No prior lines of systemic therapy for advanced disease.
• Participants who had received neoadjuvant or adjuvant therapy or definitive
chemoradiation will be allowed to participate if recurrence occurred 6 months or
longer from the completion of all prior treatments.
• Demonstrate adequate organ function as defined below; all screening labs to be
obtained within 14 days prior to registration
• Absolute Neutrophil Count (ANC) ≥1,500 /μl without the use of hematopoietic
growth factors
• Hemoglobin (Hgb) ≥8 g/dL (blood transfusions are permitted for participants with
hemoglobin levels below 8 g/dL)
• Platelets ≥100,000 /μl
• Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated
creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl
calculation using the Cockcroft-Gault formula. ≥50 mL/min for participants with
creatinine levels > 1.5 X institutional ULN
• Bilirubin within normal range for the institution (biliary drainage is allowed
for biliary obstruction)
• Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver
metastases
• Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver
metastases
• Albumin >3.0 g/dL
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless
subject is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants
• Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is
receiving anticoagulant therapy as long as PT or PTT is within therapeutic range
of intended use of anticoagulants
• Women of childbearing potential should have a negative urine or serum pregnancy test
within 14 days of study registration. NOTE: Women are considered of child bearing
potential unless they are surgically sterile (have undergone a hysterectomy, bilateral
tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at
least 12 consecutive months
• Women of childbearing potential and males must be willing to abstain from heterosexual
activity or to use a form of effective method of contraception from the time of
informed consent until 30 days after treatment discontinuation.
• As determined by the enrolling physician or protocol designee, ability of the subject
to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
• Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the
components of nal-IRI and other liposomal products.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to
enrollment).
• Other active malignancy requiring treatment within the last 2 years. Exceptions
include subjects with non-melanoma skin cancer, non-invasive/in situ cancer or
low-risk prostate cancer requiring hormonal therapy only.
• Current therapy with other investigational agents or participation in another clinical
study (supportive care and nontherapeutic trial participation allowed if not receiving
an investigational drug). Participants may participate in prescreening for other
therapeutic trials (prescreening of biologic sample for specific mutations, receptors,
etc.)
• Major surgery within 28 days or minor surgery within 14 days of the start of the study
treatment, except for tumor biopsy or placement of central infusion device (port
placement).
• Radiotherapy less than 7 days prior to the start of the study treatment
• Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should
not have any contraindications to immune checkpoint inhibitors and should not have
received immunotherapy agents for the treatment of EGA prior to study enrollment.
• Participants must not have active autoimmune disease that has required systemic
treatment in the past 2 years. Participants are permitted to receive
immunotherapy l if they have vitiligo, type I diabetes mellitus, residual
hypothyroidism due to autoimmune condition only requiring hormone replacement,
psoriasis not requiring systemic treatment, or conditions not expected to recur
in the absence of an external trigger (precipitating event).
• Participants must not have a condition requiring systemic treatment with either
corticosteroids (>10 mg/day prednisone equivalents) or other immunosuppressive
medications within 14 days of study immunotherapy administration. Inhaled or
topical steroids and adrenal replacement doses (≤10 mg/day prednisone equivalent)
are permitted. Participants with prior immune mediated adverse events related to
immunotherapy that resulted in permanent treatment discontinuation with these
agents.
• Psychological, familial, or sociological condition potentially hampering compliance
with the study protocol and follow-up schedule.
• Active infection requiring systemic therapy.
• Pregnant or breastfeeding.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they
are stable (without evidence of progression by imaging for at least four weeks prior
to the first dose of trial treatment and any neurologic symptoms have returned to
baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to trial treatment. This exception does not include
carcinomatous meningitis, which is excluded regardless of clinical stability.
• Severe arterial thromboembolic events (myocardial infarction, unstable angina
pectoris, stroke) less than 6 months before inclusion.
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled
blood pressure.
• Known history of Human Immunodeficiency Virus (HIV).
Immunonutrition and Carbohydrate Loading Strategies in Breast Reconstruction
This study is designed to test the following hypothesis: patients undergoing immediate
alloplastic and autologous breast reconstruction following mastectomy that receive
preoperative immunonutrition will experience a reduction in wound complications in the 30-day
postoperative period compared to a standard of care control group (retrospective chart
review) of 264 (132 alloplastic + 132 autologous) consecutive breast reconstruction patients
prior to 5/25/2018.
Katherine Gast
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03764943
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Medically cleared to undergo oncologic resection and breast reconstructive surgery
(including associated anesthesia) at the University of Wisconsin Hospital
• Undergoing unilateral or bilateral immediate alloplastic or autologous breast
reconstruction by Drs. Afifi, Garland, Gast, Michelotti, Poore, Rao, or Siebert
Exclusion Criteria:
• Pregnant or breast-feeding women
• Incarcerated women
• Males
• Individuals unable to give consent due to another condition such as impaired
decision-making capacity
• Women with intolerance or allergy to any ingredients contained within the Impact
Advanced Recovery formula that prevents safe consumption of this product.
• Impact Advanced Recovery is suitable for lactose intolerance, gluten-free,
kosher, and halal diets.
• We will exclude individuals with galactosemia
• Women who are unable to take oral nutritional supplements
Breast, Wound Complication, Wound Heal, Complications Wound, Surgical Wound Infection, Surgical Site Infection, Breast Cancer, Mastectomy, Lymphedema
Treatment of Cytomegalovirus (CMV) Infections With Viral-Specific T Cells
The present trial will consist of the treatment of 20 pediatric and adult Hematopoietic Stem
Cell Transplantation (HSCT) recipients or immunocompromised participants diagnosed with
opportunistic Cytomegalovirus (CMV) infections with virus-specific, antigen-selected T-cells.
CMV-specific T-cells will be isolated from donor leukapheresis products using the CliniMACS®
Prodigy. Prior studies on transfer of CMV specific T-cells have been shown to be safe and
efficacious in the treatment of CMV infections.
The main trial objective is to evaluate the feasibility and safety of CMV-specific T-cell
transfer in adult and pediatric participants suffering from CMV infections or reactivation
following HSCT or due to other immunocompromised states (e.g.; primary immunodeficiency,
cytotoxic therapy).
Participants will be followed for one year.
Kenneth Desantes, M.D.
All
1 Month and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03798301
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Adult or pediatric patient suffering from CMV reactivation/infections following HSCT
or due to other immunocompromised states (e.g.; primary immunodeficiency, cytotoxic
therapy).
• CMV reactivation/viremia defined as positive (>500 copies/ml) CMV qPCR and/or
• Presence of symptoms secondary to CMV infection or evidence of invasive CMV
infection (e.g. pneumonitis, colitis) AND
• Patients must have ONE OF THE FOLLOWING CRITERIA:
• Absence of an improvement of viral load after ≥ 14 days of antiviral therapy
with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log,
i.e. 10-fold), or
• New, persistent and/or worsening CMV-related symptoms, signs and/or markers
of end organ compromise while on antiviral therapy with ganciclovir,
valganciclovir or foscarnet, or
• Have contraindications or experience adverse effects of antiviral therapy
with ganciclovir, valganciclovir or foscarnet, or
• Known resistance to ganciclovir and/or foscarnet based on molecular testing.
2. Recipients of an allogeneic HSCT must be 28 days after stem cell infusion at the time
of T-cell transfer.
3. Written informed consent given by patient or legal representative.
4. Minimum patient age 1 month.
5. Minimum weight 7 lbs.
6. Female patients of childbearing age with negative pregnancy tests.
7. Patient Karnofsky/Lansky Performance Status >30%.
8. Donor eligible based on FACT infectious screening requirements.
Exclusion Criteria:
1. Patient with acute GVHD > grade 2 or active moderate or severe chronic GVHD at time of
T-cell transfer
2. Patient receiving steroids (>1.0 mg/kg body weight (BW) prednisone equivalent) at the
time of T-cell transfer
3. Patient received allogeneic HSCT less than 28 days prior to T-cell transfer
4. Patient treated with donor lymphocyte infusion (DLI) within 28 days prior to T-cell
transfer
5. Patient treated with Thymoglobulin (ATG), Alemtuzumab or T-cell immunosuppressive
monoclonal antibodies within 28 days.
6. Patient with organ dysfunction or failure as determined by Karnofsky (patients >16
years) or Lansky (patients ≤16 years) score ≤30% (Appendix 5)
7. Patients with CMV retinitis
8. Concomitant enrollment in another clinical trial with endpoints interfering with this
study
9. Any medical condition which could compromise participation in the study according to
the investigator's assessment
10. Known HIV infection
11. Female patient who is pregnant or breast-feeding, or adult of reproductive potential
not willing to use an effective method of birth control during study treatment. Note:
Women of childbearing potential must have a negative serum pregnancy test at study
entry.
12. Patients unwilling or unable to comply with the protocol or unable to give informed
consent.
Donor Eligibility:
The original donor will be the first choice as source of T cells. If the original donor is
not available for donation (such as NMDP donor, cord blood unit, or related donor not
available) of peripheral mononuclear cells or does not meet all donor eligibility criteria
(including donor selection criteria based on University of Wisconsin •Madison Standard
Operating Procedures for the selection of allogeneic donors), alternative related donors
will be selected, with preference for those who have full HLA matching in 6/6 loci over
those with partial HLA matching (≥ 3/6 HLA loci).
1. All donors must be ≥ 18 years old, available, CMV IgG positive, eligible and capable
of undergoing a single standard 2 blood volume leukapheresis. If original HSCT donor
is not available, CMV IgG negative or ineligible, a CMV IgG positive fully matched or
haploidentical family donor will be used.
2. Related donors must be at least partially HLA compatible, matching with recipient in
at least 3/6 HLA loci (HLA-A, HLA-B and HLA-DRB1 will be considered for this).
3. Donors must be CMV IgG seropositive.
4. Donors must show CMV T-cell activation after incubation with MACS GMP PepTivator
Peptide Pools of CMV pp65 before undergoing leukapheresis.
5. Donor must meet the criteria for donor selection defined in the Standard Operating
Procedures of the University of Wisconsin Hospitals and Clinics Stem Cell Transplant
Program and in FACT standards.
First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the
genetic and environmental variables that cause those plaques to become symptomatic. Second,
to differentiate between vulnerable plaque and other types of plaque using ultrasound
elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of
back-scattered ultrasonic echoes.
Robert Dempsey, MD
All
18 Years to 80 Years old
NA
This study is NOT accepting healthy volunteers
NCT00214006
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Male and Female patients aged 18-80 presenting for carotid endarterectomy
Exclusion Criteria:
• Patients not felt suitable for carotid endarterectomy and those with impaired
decision-making capacity
Childhood Allergy and the Neonatal Environment (CANOE)
The purpose of this research study is to study the relationship between childhood asthma,
allergies, and early-life environmental factors that may cause childhood asthma and
allergies. Previous birth cohort studies have found early-life environmental factors such as
allergies, pollutants, viruses and bacteria have all contributed to the development of asthma
and allergies. Investigators are doing this research because there continues to be a strong
need to understand the root causes of asthma and allergies. The CANOE study is an
observational cohort study, which means investigators are not asking participants or
participant's child to change their medications and investigators will not be giving
participants or participant's child a study drug.
Anne Singh
All
Not specified
NA
This study is NOT accepting healthy volunteers
NCT04215783
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic
parent or sibling (at least one shared biological parent) by parental report. The
presence of paternal or sibling allergy or asthma will be ascertained by maternal
report.
2. Maternal age greater than or equal to 18 years at the time of study enrollment.
Exclusion Criteria:
1. Maternal HIV infection at time of delivery.
2. Plans for the family to move out of the geographic area during the period of the
study.
3. Does not speak English.
4. Current maternal use of progesterone during pregnancy to prevent preterm birth.
• Progesterone use is only an exclusion if currently being taken at time of
enrollment for preterm birth. Previous use to prevent preterm birth or use at any
time for other indications is allowed.
5. Pregnancy is a result of an embryo donor (egg and sperm donor pregnancies are
permitted).
6. Past or current medical problems or findings from physical examination or laboratory
testing which, in the opinion of the investigator or designee, may pose additional
risks from participation in the study, may interfere with the participant's ability to
comply with study requirements or that may impact the quality or interpretation of the
data obtained from the study.
Asthma in Children, Allergy, Allergic rhinitis due to animal (cat) (dog) hair and dander, Allergic rhinitis due to food, Allergic rhinitis due to pollen, Asthma, Other, Infections, Immune System & Allergies
*Note: Email is generally not a secure way to communicate sensitive or health-related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email.