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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 49.5 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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 2

~2010

Cisplatin

2013

Completed Phase 3

~1940

5-fluorouracil

2005

Completed Phase 4

~7960

oxaliplatin

2002

Completed Phase 3

~6370

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,580,243 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,052,992 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,061,901 Total Patients Enrolled

Media Library

5-fluorouracil (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03675737 — Phase 3

5-fluorouracil (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03675737 — Phase 3

Stomach Tumors Research Study Groups: Pembrolizumab + Chemotherapy (FP or CAPOX regimen), Placebo + Chemotherapy (FP or CAPOX regimen)

Stomach Tumors Clinical Trial 2023: 5-fluorouracil Highlights & Side Effects. Trial Name: NCT03675737 — Phase 3

Frequently Asked Questions

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

Pembrolizumab is often prescribed to help patients with what condition?

"Pembrolizumab is an effective treatment for refractory fallopian tube carcinoma, malignant neoplasms, and unresectable melanoma."

Answered by AI

Does Pembrolizumab have any adverse effects?

"Pembrolizumab has received a score of 3 for safety. This assessment comes from our team at Power, and it takes into account that Pembrolizumab is a Phase 3 trial medication."

Answered by AI

Are there precedents for Pembrolizumab's effectiveness?

"Out of the 2204 ongoing studies on Pembrolizumab, 554 are currently in Phase 3. The locations with the most trials for this medication are Guangzhou, Guangdong; however, there are 89319 total clinical trial sites worldwide."

Answered by AI

Are there any patients that this trial is still recruiting?

"This particular trial is not currently looking for new participants, as noted on clinicaltrials.gov. The study was originally posted on November 8th, 2018 and was updated most recently on August 16th, 2022. Although this research is not taking any more patients right now, there are 3403 other trials that are still enrolling candidates."

Answered by AI