Study on Nivolumab, Ipilimumab, and Chemoradiation for Treating Patients with Stomach Cancer That Can Be Removed by Surgery

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03776487

Provider View

This clinical trial is exploring the effects of combining immunotherapy drugs nivolumab and ipilimumab with chemotherapy and radiation therapy to treat patients with stomach cancer that can be surgically removed. The study aims to determine if this combination is safe and effective in controlling the cancer.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with stomach cancer that can be removed by surgery. It combines immunotherapy drugs, nivolumab and ipilimumab, with chemotherapy and radiation therapy. Immunotherapy helps the immune system attack cancer cells, while chemotherapy and radiation work to stop cancer cells from growing and spreading. The goal is to see if this combination can improve treatment outcomes for patients.

Description

The study is divided into several phases:

  1. Induction Chemotherapy: Patients receive chemotherapy drugs oxaliplatin and fluorouracil to help shrink the tumor before surgery. This treatment is given every two weeks for up to four cycles.

  2. Immunotherapy: Patients receive nivolumab and ipilimumab to boost the immune system's ability to fight cancer. Nivolumab is given every two weeks for up to six cycles.

  3. Chemoradiation: Starting in the fourth cycle, patients receive continuous fluorouracil and undergo radiation therapy for five weeks to target the tumor more precisely.

  4. Surgery: Patients undergo surgery to remove the cancer 5-7 weeks after completing radiation therapy.

  5. Post-Surgery Treatment: If cancer remains, patients may receive additional nivolumab treatment every two weeks for 16 weeks, then every four weeks for up to two more cycles.

Patients will be monitored closely throughout the study and followed up regularly after treatment to assess their health and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must have signed a consent form agreeing to participate in the study.
  • Have stomach cancer that can be surgically removed and has not spread to other parts of the body.
  • Must not have received prior treatment for advanced or metastatic stomach cancer.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate blood cell counts and organ function as determined by specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men must agree to use contraception and refrain from donating sperm during and after the study.

Exclusion Criteria

  • Have an active autoimmune disease or require systemic treatment with steroids or other immunosuppressive drugs.
  • Have a known history of HIV or AIDS.
  • Have low white blood cell counts or positive tests for hepatitis B or C.
  • Have allergies to any of the study drugs.
  • Have had another active cancer within the past three years, except for certain skin or localized cancers.
  • Have serious or uncontrolled medical conditions.
  • Have received prior treatment with certain immunotherapy drugs targeting T-cell pathways.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.