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Anti-metabolites

Immunotherapy + Chemoradiation for Gastric Cancer

Phase 2

Waitlist Available

Led By Mariela Blum

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Subject must be previously untreated with systemic treatment (including HER 2 inhibitors) given as primary therapy for advanced or metastatic disease. No prior neoadjuvant chemotherapy, immunotherapy, radiotherapy and/or chemoradiotherapy are permitted.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Must not have

Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy drugs, chemo, and radiation to treat gastric cancer. The hope is that the immunotherapy will help the body's immune system attack the cancer, and that the combination of treatments will be more effective than any one treatment alone.

Who is the study for?

This trial is for patients with resectable gastric or gastroesophageal junction adenocarcinoma, without prior systemic treatment for advanced disease. Participants must have adequate organ function and performance status, not be pregnant or breastfeeding, and agree to contraception if applicable. Exclusions include previous immunotherapy, certain allergies, active autoimmune diseases requiring steroids, other cancers within 3 years (with exceptions), HIV/AIDS positive status, and serious uncontrolled medical disorders.

What is being tested?

The study tests the combination of nivolumab and ipilimumab (immunotherapies) with chemotherapy drugs oxaliplatin and fluorouracil plus intensity-modulated radiation therapy in treating resectable gastric cancer. The goal is to see how well this combo works by helping the immune system attack cancer while minimizing damage to healthy tissue.

What are the potential side effects?

Potential side effects may include typical reactions from immunotherapy such as fatigue, skin reactions, digestive issues; chemotherapy-related nausea, hair loss; radiation-induced skin changes; increased risk of infections due to a weakened immune system; liver enzyme elevation; blood cell count changes.

Eligibility Criteria

Inclusion Criteria

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

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I have not received any systemic treatment for my advanced or metastatic disease.

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

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I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.

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I have a type of stomach or junction cancer that can be operated on and has not spread to my abdomen.

Exclusion Criteria

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

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I have been treated with specific immune system targeting drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Disease-free survival

Incidence of adverse events in patients with resected gastroesophageal junction (GEJ) or gastric cancer

Response rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, immunotherapy, IMRT)Experimental Treatment6 Interventions

INDUCTION CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV over 48 hours on day 1. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment with nivolumab repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning course 4, patients also receive fluorouracil IV continuously for 5 days per week and undergo 25 fractions of IMRT for 5 weeks. Patients undergo surgical resection 5-7 weeks after completing radiation therapy. Within 8-12 weeks post-surgery, patients with residual disease may receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for 8 courses (16 weeks) then every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Therapeutic Conventional Surgery

2005

Completed Phase 3

~9930

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160