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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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.

Eligibility

Primary outcome measure(s)

• Objective response rate (ORR) — Through study completion, an average of 2 years
  ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)
• The number of participants with adverse events/serious adverse events — Through study completion, an average of 2 years
  Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
• Progression free survival (PFS) — Through study completion, an average of 2 years
  PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)

Trial sites (46)

+ 6 more sites — see the full list on the official registry below.

On this site

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