This study is in progress, not accepting new patients

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

a study on Hepatocellular Cancer Liver Cancer Biliary Tract Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Farshid Dayyani (uci)

Description

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.

Official Title

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)

Details

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.

Keywords

Hepatocellular Carcinoma, Biliary Tract Cancer, Hepatobiliary cancer, GEMINI-Hepatobiliary, MEDI5752, AZD2936, Bispecific antibody, Volrustomig, Rilvegostomig, Biliary Tract Neoplasms, Bevacizumab, lenvatinib, Gemcitabine, Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site
    Orange California 92868 United States
  • Research Site
    Los Angeles California 90089 United States

Lead Scientist at University of California Health

  • Farshid Dayyani (uci)
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 134 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT05775159
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 294 study participants
Last Updated