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 Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152) (SKYSCRAPER-14)
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT
monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as
first-line treatment, in participants with unresectable, locally advanced or metastatic
hepatocellular carcinoma (HCC).
Jeremy Kratz, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT05904886
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Inclusion Criteria:
• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by
histology/cytology or clinically by American Association for the Study of Liver
Diseases (AASLD) criteria in cirrhotic participants
• Disease that is not amenable to curative surgical and/or locoregional therapies
• No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC
• Measurable disease according to RECIST v1.1
• ECOG Performance Status of 0 or 1 within 7 days prior to randomization
• Child-Pugh Class A within 7 days prior to randomization
• Adequate hematologic and end-organ function
• Female participants of childbearing potential must be willing to avoid pregnancy
within 5 months after the final dose of atezolizumab, within 6 months after the final
dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
• Male participants with a female partner of childbearing potential or pregnant female
partner must remain abstinent or use a condom during the treatment period and for 6
months after the final dose of bevacizumab and for 90 days after the final dose of
tiragolumab/placebo to avoid exposing the embryo.
Exclusion Criteria:
• Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab,
within 6 months after the final dose of bevacizumab, and within 90 days after the
final dose of tiragolumab/placebo
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies
• Treatment with investigational therapy within 28 days prior to initiation of study
treatment
• Treatment with locoregional therapy to liver within 28 days prior to initiation of
study treatment, or non-recovery from side effects of any such procedure
• Treatment with systemic immunostimulatory agents
• Treatment with systemic immunosuppressive medication
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or
that are at high risk for bleeding
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior
to initiation of study treatment
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan
• History of malignancy other than HCC within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death
• Mixed histology or other subtypes/variants of HCC, including, but not limited to,
known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC
variant, or mixed cholangiocarcinoma and HCC
• Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
• Acute Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV
infection
• Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases.
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
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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
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