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

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Biliary Tract Cancer; Hepatocellular Carcinoma

Treatments: Drug: Rilvegostomig; Drug: Cisplatin; Drug: Bevacizumab; Drug: Volrustomig; Drug: Lenvatinib; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05775159

D7987C00001

Details and patient eligibility

About

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.

Full description

This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).

This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.

In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.

Enrollment: 294 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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294 participants in 7 patient groups

Cohort 1A

Experimental group

Description:

Volrustomig monotherapy

Treatment:

Drug: Volrustomig

Cohort 1B

Experimental group

Description:

Volrustomig combination with bevacizumab

Treatment:

Drug: Volrustomig

Drug: Bevacizumab

Cohort 1C

Experimental group

Description:

Volrustomig combination with lenvatinib

Treatment:

Drug: Lenvatinib

Drug: Volrustomig

Cohort 2A

Experimental group

Description:

Rilvegostomig combination with Gemcitabine and Cisplatin

Treatment:

Drug: Gemcitabine

Drug: Cisplatin

Drug: Rilvegostomig

Cohort 2B

Experimental group

Description:

Volrustomig combination with Gemcitabine and Cisplatin

Treatment:

Drug: Gemcitabine

Drug: Volrustomig

Drug: Cisplatin

Cohort 1D

Experimental group

Description:

Volrustomig combination with rilvegostomig and bevacizumab

Treatment:

Drug: Volrustomig

Drug: Bevacizumab

Drug: Rilvegostomig

Cohort 1E

Experimental group

Description:

Rilvegostomig combination with bevacizumab

Treatment:

Drug: Bevacizumab

Drug: Rilvegostomig