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Chemotherapy

Pembrolizumab + Chemotherapy for Stomach Cancer

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

Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma with known programmed cell death ligand 1 (PD-L1) expression status

Has human epidermal growth factor receptor 2 (HER2) negative cancer

Must not have

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has squamous cell or undifferentiated gastric cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 49.5 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether adding pembrolizumab to chemotherapy helps people with HER2-negative gastric or GEJ adenocarcinoma live longer than chemotherapy alone.

Who is the study for?

Adults with HER2-negative advanced gastric or GEJ adenocarcinoma, who have not had previous treatments for advanced cancer, can join. They must be in good physical condition (ECOG 0-1), agree to use contraception, and have adequate organ function. People with active brain metastases, severe allergies to trial drugs, recent major surgery or other conditions that could affect participation are excluded.

What is being tested?

The study is testing the effectiveness of pembrolizumab combined with chemotherapy (Cisplatin/5-Fluorouracil or Oxaliplatin/Capecitabine) versus a placebo plus chemotherapy in treating stomach tumors. The main goal is to see if pembrolizumab helps patients live longer compared to the placebo.

What are the potential side effects?

Pembrolizumab may cause immune-related side effects like inflammation of organs, fatigue, skin reactions and infusion-related reactions. Chemotherapy can lead to nausea, hair loss, blood cell count changes and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced stomach or GEJ cancer, and I know my PD-L1 status.

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My cancer is HER2 negative.

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My cancer can be measured using specific criteria.

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I have provided a sample of my tumor that has not been treated with radiation.

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I have given a tumor sample for PD-L1 analysis.

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I have given a tissue sample for cancer genetic testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have been treated for an autoimmune disease in the last 2 years.

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My cancer is a type of stomach cancer called squamous cell or undifferentiated.

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I have active brain metastases or cancer in the lining of my brain.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.

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I have been treated with specific immune therapy for cancer.

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I have a history of Hepatitis B or active Hepatitis C.

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I have had or currently have lung inflammation treated with steroids.

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I am currently being treated for an infection.

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I have moderate to severe hearing loss from taking cisplatin.

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I have mild to severe nerve damage in my hands or feet.

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I have an active tuberculosis infection.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 49.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 49.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49.5 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) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10

Overall Survival (OS) in All Participants

Secondary study objectives

Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants

Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1

+8 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

Clostridium difficile colitis

Systemic infection

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

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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

Active Control

Group I: Pembrolizumab + Chemotherapy (FP or CAPOX regimen)Experimental Treatment5 Interventions

Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who complete up to 35 administrations of pembrolizumab (approximately 2 years) or achieve a complete response (CR) but experience progression of disease (PD), can initiate a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

Group II: Placebo + Chemotherapy (FP or CAPOX regimen)Active Control5 Interventions

Participants receive placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

capecitabine

2002

Completed Phase 3

~2360

Pembrolizumab

2017

Completed Phase 3

~2810