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Anti-metabolites

Immunotherapy + Chemotherapy for Stomach Cancer (CheckMate649 Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)

Awards & highlights

CheckMate649 Trial Summary

This trial is testing whether adding immunotherapy to chemotherapy can help people with gastric or gastroesophageal junction cancer live longer than chemotherapy alone.

Who is the study for?

Adults with advanced or inoperable gastric or gastroesophageal junction cancer are eligible. They shouldn't have had chemo or radiotherapy in the last 6 months, must be able to perform light activities, and provide a tumor tissue sample. Excluded are those with serious medical conditions, HIV/AIDS, active hepatitis B/C infection, brain/spinal cord tumors untreated, or active autoimmune diseases.Check my eligibility

What is being tested?

The trial is testing the effectiveness of combining Nivolumab with Ipilimumab or chemotherapy versus chemotherapy alone for stomach cancers. The goal is to see which treatment helps patients live longer.See study design

What are the potential side effects?

Nivolumab and Ipilimumab can cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid), diarrhea/colitis; Oxaliplatin may lead to nerve damage; Capecitabine can cause hand-foot syndrome and diarrhea.

CheckMate649 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is in the stomach or where the stomach meets the esophagus and cannot be removed by surgery.

CheckMate649 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 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 Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5

Pharmacotherapy

Secondary outcome measures

OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy

OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy

Objective Response Rate

+3 more

CheckMate649 Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab + XELOXExperimental Treatment3 Interventions

Group II: Nivolumab + IpilimumabExperimental Treatment2 Interventions

Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy Enrollment is closed for this arm

Group III: Nivolumab + FOLFOXExperimental Treatment4 Interventions

Group IV: XELOX (Oxaliplatin + Capecitabine)Active Control2 Interventions

Group V: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)Active Control3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2670

Oxaliplatin

2011

Completed Phase 4

~2560

Capecitabine

2013

Completed Phase 3

~3420

Leucovorin

2005

Completed Phase 4

~5730

Fluorouracil

2014

Completed Phase 3

~11540

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,126,483 Total Patients Enrolled

Ono Pharmaceutical Co. LtdIndustry Sponsor

154 Previous Clinical Trials

92,492 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02872116 — Phase 3

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02872116 — Phase 3

Esophageal Cancer Research Study Groups: Nivolumab + FOLFOX, Nivolumab + Ipilimumab, XELOX (Oxaliplatin + Capecitabine), FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil), Nivolumab + XELOX

Esophageal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT02872116 — Phase 3

Frequently Asked Questions

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

How does Nivolumab's clinical trial results compare to other similar drugs?

"Nivolumab is being researched in 1532 active clinical trials, 335 of which are in Phase 3. While some research for Nivolumab is happening Guangzhou, Guangdong, there are 72904 total locations running studies involving this medication."

Answered by AI

How many people are the researchers hoping to test in this study?

"This particular clinical trial is not looking for more patients at this moment, as the last update was on September 1st, 2022. However, there are 1328 trials actively recruiting cancer patients and 1532 trials for Nivolumab with open recruitment."

Answered by AI

Does Nivolumab have a lot of dangerous side effects for the people who take it?

"Because this is a Phase 3 trial, meaning that there is data supporting efficacy and multiple rounds of safety data, we have estimated the safety of Nivolumab to be a 3."

Answered by AI

For what reasons is Nivolumab most often recommended?

"Nivolumab is a standard treatment for patients with malignant neoplasms. Additionally, Nivolumab has seen efficacy in treating other conditions like unresectable melanoma, squamous cell carcinoma of the skin, and rectal carcinoma."

Answered by AI