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Angiogenesis Inhibitor
Immunomodulators + Anticancer Agents for Hepatobiliary Cancer
Phase 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
Study Summary
This trial will study novel treatments for advanced solid tumors to assess safety, efficacy, and tolerability.
Who is the study for?
This trial is for adults over 18 with advanced hepatobiliary cancer, which includes liver and biliary tract cancers. Participants must have a measurable tumor that hasn't been treated with radiation, be expected to live at least 12 weeks, and can provide a tumor sample. It's not for those who've had organ transplants, hepatic encephalopathy in the last year, previous study participation or certain infections and autoimmune diseases.Check my eligibility
What is being tested?
The GEMINI-Hepatobiliary study is testing new immune-modifying drugs (AZD2936 & MEDI5752) alone or combined with other cancer treatments (Cisplatin, Gemcitabine, Bevacizumab & Lenvatinib). The goal is to see how effective and safe these combinations are for treating specific advanced solid tumors of the liver and bile ducts.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system affecting various organs due to immunomodulators; typical chemotherapy-related issues like nausea, fatigue; kidney problems from Cisplatin; high blood pressure from Bevacizumab; and possibly thyroid dysfunction from Lenvatinib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of participants with adverse events/serious adverse events
Secondary outcome measures
Anti Drug Antibody (ADA)
Disease Control Rate (DCR)
Duration Of Response (DOR)
+6 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Cohort 2BExperimental Treatment3 Interventions
Volrustomig combination with Gemcitabine and Cisplatin
Group II: Cohort 2AExperimental Treatment3 Interventions
Rilvegostomig combination with Gemcitabine and Cisplatin
Group III: Cohort 1EExperimental Treatment2 Interventions
Rilvegostomig combination with bevacizumab
Group IV: Cohort 1DExperimental Treatment3 Interventions
Volrustomig combination with rilvegostomig and bevacizumab
Group V: Cohort 1CExperimental Treatment2 Interventions
Volrustomig combination with lenvatinib
Group VI: Cohort 1BExperimental Treatment2 Interventions
Volrustomig combination with bevacizumab
Group VII: Cohort 1AExperimental Treatment1 Intervention
Volrustomig monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Lenvatinib
2005
Completed Phase 4
~2690
Gemcitabine
2017
Completed Phase 3
~2070
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,289 Previous Clinical Trials
288,619,938 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection, brain metastases, or spinal cord compression.I have both hepatitis B and D.My organs and bone marrow are working well.I am 18 years old or older.My cancer is advanced or has spread and is confirmed by tissue analysis.I have at least one cancer spot that can be measured and hasn't been treated with radiation.I can provide a sample of my tumor for testing.I have had hepatic encephalopathy in the last year.I do not have any unmanaged ongoing illnesses.I have no history of other cancers, leptomeningeal disease, or immune disorders.I have or had an autoimmune or inflammatory disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1D
- Group 2: Cohort 1E
- Group 3: Cohort 1A
- Group 4: Cohort 1B
- Group 5: Cohort 1C
- Group 6: Cohort 2A
- Group 7: Cohort 2B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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