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Platinum-containing compound

Pembrolizumab + Chemotherapy for Bile Duct Cancer (KEYNOTE-966 Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Has adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 38 months
Awards & highlights

KEYNOTE-966 Trial Summary

This trial is testing a new combination therapy for biliary tract cancer. The hypothesis is that the new therapy will improve overall survival compared to the current standard of care.

Who is the study for?
This trial is for adults with advanced or inoperable biliary tract cancer, including cholangiocarcinoma and gallbladder cancer. They must have a life expectancy over 3 months, measurable disease, and adequate organ function. It's not for those with certain other cancers like ampullary or small cell cancer, CNS metastases, previous treatments for their biliary tract cancer, or past immunotherapy.Check my eligibility
What is being tested?
The study tests if pembrolizumab combined with gemcitabine/cisplatin improves survival compared to a placebo plus the same chemotherapy in first-line treatment of biliary tract carcinoma. Participants are randomly assigned to receive either the drug combo or placebo combo.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs (like lungs and intestines), skin reactions, hormone gland problems (like thyroid dysfunction), liver issues; while gemcitabine/cisplatin can lead to nausea, kidney damage, low blood cell counts increasing infection risk.

KEYNOTE-966 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can provide a sample of my tumor for testing.
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My organs are functioning well.
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My cancer is in the bile ducts or gallbladder and cannot be removed by surgery.

KEYNOTE-966 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 38 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 38 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AE)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

KEYNOTE-966 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (Pembrolizumab+Gemcitabine+Cisplatin)Experimental Treatment3 Interventions
Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Group II: Arm B (Placebo+Gemcitabine+Cisplatin)Placebo Group3 Interventions
Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,631 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,842 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,131 Total Patients Enrolled

Media Library

Cisplatin (Platinum-containing compound) Clinical Trial Eligibility Overview. Trial Name: NCT04003636 — Phase 3
Bile Duct Cancer Research Study Groups: Arm A (Pembrolizumab+Gemcitabine+Cisplatin), Arm B (Placebo+Gemcitabine+Cisplatin)
Bile Duct Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04003636 — Phase 3
Cisplatin (Platinum-containing compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04003636 — Phase 3

Frequently Asked Questions

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

Is it dangerous to use Pembrolizumab?

"Pembrolizumab has been studied in multiple Phase 3 trials, meaning that there is evidence of its efficacy and safety. Our analysts have given it a score of 3."

Answered by AI

Could you list some of the other research studies that have used Pembrolizumab?

"Pembrolizumab is being researched in 1893 clinical trials, with 424 of those trials currently in Phase 3. Pembrolizumab is being studied all over the world, with a large concentration in Shanghai, but with research centres in 77337 locations."

Answered by AI

At how many institutions is this research project taking place?

"23 different hospitals are running this clinical trial at the moment. The locations of these facilities are in Oklahoma City, Charleston, Hamilton and 20 other cities. If you decide to participate in this research, try to enroll at a hospital that is close to your home to reduce the amount of travel required."

Answered by AI

Pembrolizumab is used to treat which medical conditions?

"Pembrolizumab is a common treatment for refractory, relapsed mediastinal large b-cell lymphoma. Pembrolizumab has also shown to be effective in treating other forms of cancer, such as urinary bladder, advanced testicular, and small cell lung cancer (sclc)."

Answered by AI
~194 spots leftby Mar 2025