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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 Corp.

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 histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)

Must not have

Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 38 months

Awards & highlights

Pivotal 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.

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.

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.

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 cancer is in the bile ducts or gallbladder and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with specific immune therapy for cancer.

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I have had treatment for advanced biliary tract cancer.

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I have or might have cancer spread to my brain or spinal cord.

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I have received an organ or tissue transplant from another person.

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I have cancer of the ampulla of Vater.

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My cancer is not small cell, neuroendocrine, lymphoma, sarcoma, mixed histology, or mucinous cystic.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 38 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Secondary study objectives

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~3130

Gemcitabine

2017

Completed Phase 3

~1920