Your session is about to expire
← Back to Search
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 belowSelect...
My cancer is advanced stomach or GEJ cancer, and I know my PD-L1 status.
Select...
My cancer is HER2 negative.
Select...
My cancer can be measured using specific criteria.
Select...
I have provided a sample of my tumor that has not been treated with radiation.
Select...
I have given a tumor sample for PD-L1 analysis.
Select...
I have given a tissue sample for cancer genetic testing.
Select...
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:Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
My cancer is a type of stomach cancer called squamous cell or undifferentiated.
Select...
I have active brain metastases or cancer in the lining of my brain.
Select...
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.
Select...
I have been treated with specific immune therapy for cancer.
Select...
I have a history of Hepatitis B or active Hepatitis C.
Select...
I have had or currently have lung inflammation treated with steroids.
Select...
I am currently being treated for an infection.
Select...
I have moderate to severe hearing loss from taking cisplatin.
Select...
I have mild to severe nerve damage in my hands or feet.
Select...
I have an active tuberculosis infection.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.
Select...
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
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
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) ≥10
+8 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
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
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
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
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
~3130
Cisplatin
2013
Completed Phase 3
~3120
5-fluorouracil
2005
Completed Phase 4
~8440
oxaliplatin
2002
Completed Phase 3
~6370
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,026 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,032 Previous Clinical Trials
5,188,222 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,905 Previous Clinical Trials
8,089,890 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for an autoimmune disease in the last 2 years.My cancer is a type of stomach cancer called squamous cell or undifferentiated.I've had treatment for advanced stomach cancer more than 6 months ago.I haven't had radiotherapy in the last 2 weeks or still have side effects from it.I haven't had cancer treatment or clinical trials in the last 4 weeks and have recovered from side effects.I have active brain metastases or cancer in the lining of my brain.My recent tests show my organs are functioning well.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.I have been treated with specific immune therapy for cancer.I have another cancer besides skin cancer that hasn't needed treatment in the last 5 years.I have a history of Hepatitis B or active Hepatitis C.I don't have health issues that could affect the study's results or my participation.My cancer is advanced stomach or GEJ cancer, and I know my PD-L1 status.My cancer is HER2 negative.I am not pregnant or breastfeeding and agree to use birth control or abstain from sex if I can have children.My cancer can be measured using specific criteria.I have provided a sample of my tumor that has not been treated with radiation.I have given a tumor sample for PD-L1 analysis.I have had or currently have lung inflammation treated with steroids.I am currently being treated for an infection.I have moderate to severe hearing loss from taking cisplatin.I agree to follow the study's rules on contraception and not donate sperm for 95 days after my last chemotherapy dose.I have mild to severe nerve damage in my hands or feet.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have an active tuberculosis infection.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have received an organ or tissue transplant from another person.I have given a tissue sample for cancer genetic testing.I am fully active or restricted in physically strenuous activity but can do light work.I have not had a live vaccine in the last 30 days.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + Chemotherapy (FP or CAPOX regimen)
- Group 2: Placebo + Chemotherapy (FP or CAPOX regimen)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.