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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

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 more

Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,415 Total Patients Enrolled

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05775159 — Phase 2

Biliary Tract Cancer Research Study Groups: Cohort 1D, Cohort 1E, Cohort 1A, Cohort 1B, Cohort 1C, Cohort 2A, Cohort 2B

Biliary Tract Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05775159 — Phase 2

Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05775159 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many sites in the city conducting this clinical trial?

"Currently, 35 clinical trial sites are participating in this research. These sites span from Orange to Beijing and many other locations between them. To minimize travel burdens, it is beneficial for patients to select the closest site if they choose to enroll."

Answered by AI

Has Cohort 1A been given the green light by the FDA?

"Our team at Power gave Cohort 1A a score of 2, signifying that while there is some evidence backing its safety profile, efficacy data has yet to be established."

Answered by AI

Is this research program open to new participants?

"As outlined on clinicaltrials.gov, the study in question is not currently recruiting individuals for participation; it was initially posted on April 6th 2023 and last amended March 17th 2023. Notwithstanding this, there are presently 738 other medical trials actively looking for participants."

Answered by AI

What is the main aim of this clinical trial?

"The purpose of this two-year clinical trial is to identify the number of participants experiencing adverse events or serious adverse effects. Secondary objectives include assessing Disease Control Rate (DCR) at 12 and 24 weeks, evaluating Progression Free Survival (PFS), and measuring Overall Survival (OS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05775159.