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RECRUITINGPhase 2INTERVENTIONAL

Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

A Phase II, Open-Label, Multi-Drug, Multi-Center, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.

Who May Be Eligible (Plain English)

Who May Qualify: - Age ≥18 years at the time of signing the ICF. - Provision of a signed and dated written ICF. - Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology. - Adequate organ and bone marrow function. - At least 1 measurable not previously irradiated lesion per RECIST 1.1 - expected to live at least 12 weeks at the time of screening. - Willing and able to provide an adequate tumor sample. Who Should NOT Join This Trial: - History of allogeneic organ transplantation. - Active or prior documented autoimmune or inflammatory disorders. - Uncontrolled intercurrent illness. - History of another primary malignancy, leptomeningeal carcinomatosis, and active primary weakened immune system. - Active infection, brain metastases or spinal cord compression. - Participants co-infected with HBV and hepatitis D virus (HDV). - Previous treatment in the present study. - For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age ≥18 years at the time of signing the ICF. * Provision of a signed and dated written ICF. * Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology. * Adequate organ and bone marrow function. * At least 1 measurable not previously irradiated lesion per RECIST 1.1 * Life expectancy of at least 12 weeks at the time of screening. * Willing and able to provide an adequate tumor sample. Exclusion Criteria: * History of allogeneic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders. * Uncontrolled intercurrent illness. * History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency. * Active infection, brain metastases or spinal cord compression. * Participants co-infected with HBV and hepatitis D virus (HDV). * Previous treatment in the present study. * For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

Treatments Being Tested

DRUG

Volrustomig

CTLA-4/Anti-PD-1 Bispecific Antibody

DRUG

Bevacizumab

15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

DRUG

Lenvatinib

Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

DRUG

Rilvegostomig

anti- PD-1 and TIGIT bispecific antibody

DRUG

Gemcitabine

1000 mg/m2, IV infusion

DRUG

Cisplatin

25 mg/m2, IV infusion

Locations (20)

Research Site
Birmingham, Alabama, United States
Research Site
Costa Mesa, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
Miami Beach, Florida, United States
Research Site
Dyer, Indiana, United States
Research Site
Kansas City, Kansas, United States
Research Site
New York, New York, United States
Research Site
Dallas, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guangzhou, China
Research Site
Harbin, China