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Chemotherapy

Combination Chemotherapy + Immunotherapy for Biliary Tract Cancer

Phase 2

Waitlist Available

Led By Marina Baretti, M.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a newly diagnosed, biopsy-proven biliary tract cancer (BTC) including gallbladder, intrahepatic, extrahepatic, and hilar cholangiocarcinoma

Resectable BTC (biliary tract cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial studies if a combination of drugs is safe & effective in treating bile duct cancer patients.

Who is the study for?

This trial is for adults with newly diagnosed, biopsy-proven biliary tract cancer that can potentially be removed by surgery. Participants must have good performance status, adequate organ function, and controlled hepatitis if present. They should not have HIV/AIDS or active autoimmune diseases and must agree to use birth control.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of a combination treatment using gemcitabine, cisplatin, and pembrolizumab before and after potential surgery in patients with biliary tract cancers. It aims to see if this regimen leads to significant tumor shrinkage.See study design

What are the potential side effects?

Possible side effects include reactions related to infusion, fatigue, liver issues due to chemotherapy drugs like cisplatin and gemcitabine; immune-related effects from pembrolizumab such as inflammation in organs or skin problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with a type of biliary tract cancer.

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My biliary tract cancer can be surgically removed.

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I am 18 years old or older.

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I am fully active or able to carry out light work.

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My organ and bone marrow functions meet the required levels.

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My liver is working well, according to recent tests.

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I am a woman who can have children and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

Average minimum Euclidean distance from CD8+ T cells to immunosuppressive tumor-associated macrophages (TAMs) at the per-cell level in patients with a major pathologic response versus pathologic non-responders.

Secondary outcome measures

Major pathologic response rate

Number of participants experiencing grade 3 or above drug-related toxicities

Number of patients proceeding to surgery without an extended treatment-related delay as a measure of feasibility

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine, Cisplatin and PembrolizumabExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~2070

Cisplatin

2013

Completed Phase 3

~1940

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,887 Previous Clinical Trials

5,054,947 Total Patients Enrolled

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,873 Total Patients Enrolled

Marina Baretti, M.D.Principal InvestigatorSKCCC Johns Hopkins Medical Institution

Frequently Asked Questions

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

Can you expound upon the security of Gemcitabine, Cisplatin and Pembrolizumab for human beings?

"Our team at Power rates Gemcitabine, Cisplatin and Pembrolizumab's safety as a 2 due to the lack of efficacy data in this Phase 2 trial."

Answered by AI

Does this clinical investigation currently accept participants?

"According to clinicaltrials.gov, the trial which initially was posted on December 1st 2023 and last edited 8/16/2023 is no longer in search of candidates. Nevertheless, there are presently 507 other trials that require patient recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers

2024. "Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06001658.