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)
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)
Original Eligibility Criteria
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Treatments Being Tested
Volrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
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.
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.
Rilvegostomig
anti- PD-1 and TIGIT bispecific antibody
Gemcitabine
1000 mg/m2, IV infusion
Cisplatin
25 mg/m2, IV infusion