Immunotherapy + Chemoradiation for Gastric Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMariela Blum

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses thin beams of radiation of different strengths aimed at the tumor from many angles. This type of radiation therapy may reduce the damage to healthy tissue near the tumor. Giving nivolumab, ipilimumab, chemotherapy and radiation therapy may work better in treating patients with gastric cancer.

Eligibility Criteria

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.

Inclusion Criteria

Subjects must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

My kidney function is within the required range for the study.

Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days of treatment initiation).

+12 more

Exclusion Criteria

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

White blood cell (WBC) < 2000/uL.

I haven't had any cancer except for certain skin, bladder, prostate, cervix, or breast cancers in the last 3 years.

+6 more

Participant Groups

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.

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.

Fluorouracil is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as 5-Fluorouracil for: