RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2023-04-24
Study Completion:2027-01-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05775159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 years at the time of signing the ICF.
  2. * Provision of a signed and dated written ICF.
  3. * Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
  4. * Adequate organ and bone marrow function.
  5. * At least 1 measurable not previously irradiated lesion per RECIST 1.1
  6. * Life expectancy of at least 12 weeks at the time of screening.
  7. * Willing and able to provide an adequate tumor sample.
  1. * History of allogeneic organ transplantation.
  2. * Active or prior documented autoimmune or inflammatory disorders.
  3. * Uncontrolled intercurrent illness.
  4. * History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
  5. * Active infection, brain metastases or spinal cord compression.
  6. * Participants co-infected with HBV and hepatitis D virus (HDV).
  7. * Previous treatment in the present study.
  8. * For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Costa Mesa, California, 92627
United States
Research Site
Los Angeles, California, 90089
United States
Research Site
Orange, California, 92868
United States
Research Site
Miami Beach, Florida, 33140
United States
Research Site
Dyer, Indiana, 46311
United States
Research Site
Kansas City, Kansas, 66103
United States
Research Site
New York, New York, 10065
United States
Research Site
Dallas, Texas, 75251
United States
Research Site
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-24
Study Completion Date2027-01-26

Study Record Updates

Study Start Date2023-04-24
Study Completion Date2027-01-26

Terms related to this study

Keywords Provided by Researchers

  • Hepatobiliary cancer
  • Hepatocellular carcinoma
  • Biliary tract cancer
  • GEMINI-Hepatobiliary
  • MEDI5752
  • AZD2936
  • Bispecific antibody
  • Volrustomig
  • Rilvegostomig

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Biliary Tract Cancer