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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 previously untreated localized gastric or GEJ adenocarcinoma as defined by T3 or greater primary lesion or the presence of any positive nodes - N+ (clinical nodes) without evidence of metastatic disease
Plans to proceed to surgery following pre-operative chemotherapy based on standard staging studies per local practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights

Study Summary

This trial will study whether the use of pembrolizumab can help treat patients with gastric or GEJ adenocarcinoma.

Who is the study for?
Adults with untreated gastric or GEJ adenocarcinoma, planning surgery after chemotherapy, able to provide tissue samples, and in good physical condition (ECOG score 0-1). Must have a life expectancy over 6 months and adequate organ function. Women must use contraception for 180 days post-chemo or 120 days post-pembrolizumab; men also need to agree to contraception.Check my eligibility
What is being tested?
The trial is testing if pembrolizumab plus chemotherapy before and/or after surgery is better than placebo plus chemotherapy for increasing the time without cancer events (EFS) and improving complete response rates at surgery in stomach/GEJ cancer patients.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation of organs, infusion reactions, fatigue, skin issues, hormonal gland problems (like thyroid), lung issues (pneumonitis), digestive tract problems, liver inflammation, muscle pain/joint pain/arthritis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My stomach cancer has not spread but is advanced.
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I plan to have surgery after chemotherapy, as recommended by my doctors.
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I agree to give tumor tissue samples before and during surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 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
Pharmacotherapy
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Pathological Complete Response (pathCR) Rate - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
+2 more
Secondary outcome measures
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts
Overall Survival (OS) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy Treatment Arms and Pembrolizumab+FLOT and Placebo+FLOT Cohorts
+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

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab+FLOT CohortExperimental Treatment5 Interventions
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W PLUS docetaxel 50 mg/m^2, oxaliplatin 85 mg/m^2, 5FU 2600 mg/m^2, and leucovorin 200 mg/m^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Group II: Pembrolizumab+ChemotherapyExperimental Treatment4 Interventions
Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Group III: Placebo+ChemotherapyPlacebo Group4 Interventions
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle. Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m^2 via IV infusion on Day 1 Q3W and 5FU 800 mg/m^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Group IV: Placebo+FLOT CohortPlacebo Group5 Interventions
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations). Adjuvant: 4 to 10 weeks postsurgery, participants receive 3 cycles of placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m^2 via IV infusion, oxaliplatin 85 mg/m^2 via IV infusion, 5FU 2600 mg/m^2 via IV infusion, and leucovorin 200 mg/m^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3, for 4 administrations), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Capecitabine
FDA approved
Docetaxel
FDA approved
Leucovorin
FDA approved
Pembrolizumab
FDA approved
Oxaliplatin
FDA approved
Fluorouracil
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,904 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,693 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,193 Total Patients Enrolled

Media Library

5-fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03221426 — Phase 3
Stomach Cancer Research Study Groups: Pembrolizumab+Chemotherapy, Placebo+Chemotherapy, Pembrolizumab+FLOT Cohort, Placebo+FLOT Cohort
Stomach Cancer Clinical Trial 2023: 5-fluorouracil Highlights & Side Effects. Trial Name: NCT03221426 — Phase 3
5-fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03221426 — Phase 3

Frequently Asked Questions

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

What are the Pembrolizumab safety trials looking like?

"Pembrolizumab has undergone multiple rounds of testing, with some data supporting efficacy, which gives it a safety rating of 3."

Answered by AI

What are the maladies that Pembrolizumab has been shown to ameliorate?

"Pembrolizumab is the standard treatment for esophageal neoplasms malignant. Additionally, pembrolizumab can also help patients with actinic keratosis, disease, and hodgkin disease."

Answered by AI

Out of how many people apply, how many are typically accepted into this type of program?

"This particular study is no longer looking for patients to participate. However, there are 1139 other trials for patients with malignant neoplasms and 2442 trials for Pembrolizumab that are ongoing."

Answered by AI

Why was this clinical trial designed in this way?

"According to the sponsor of the trial, Merck Sharp & Dohme Corp., the primary outcome will be Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts, and it will be measured over a Up to approximately 2 years time span. Additionally, this study will measure secondary outcomes including Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+Chemotherapy and Placebo+Chemotherapy"

Answered by AI

What other testing has been done with Pembrolizumab in the past?

"Pembrolizumab was first evaluated in 1997 at City of Hope Comprehensive Cancer Center. So far, 21054 clinical trials have been completed. There are currently 2442 ongoing studies, with a significant number of these trials based in Edmonton, Alberta."

Answered by AI

In how many different hospitals is this clinical study being offered?

"There are 22 different hospitals conducting this trial at the moment. Some of the locations include Edmonton, Fairfax and Greenfield Park. If you are considering participating, it would be most convenient for you to select a hospital close to your home to limit travel."

Answered by AI
Recent research and studies
~136 spots leftby Mar 2025