Nivolumab + Radiation for Gastroesophageal Cancer

Palo Alto (17 mi)

Overseen byManish Shah, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab.

Eligibility Criteria

Adults over 18 with advanced gastroesophageal adenocarcinoma that can't be surgically removed or has spread, who haven't progressed after initial FOLFOX and Nivolumab therapy. Participants need normal organ function, not pregnant, willing to use birth control, and able to provide a recent tumor tissue sample. Excludes those with immune deficiencies, active infections or other cancers within the last 3 years (with some exceptions), autoimmune diseases requiring treatment in the past 2 years, known HIV/Hepatitis B/C, or prior anti-PD-1/L1/L2 therapies.

Inclusion Criteria

I am older than 18 years.

I have advanced cancer that started in my stomach or esophagus and it can't be removed by surgery.

I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

My cancer is HER2 positive adenocarcinoma.

I am currently on medication for an infection.

I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I have an active tuberculosis infection.

I have or had lung inflammation not caused by an infection.

Treatment Details

This phase II trial is testing whether adding radiation therapy to nivolumab offers any benefit compared to nivolumab alone for patients whose cancer hasn't worsened following initial treatment with FOLFOX chemotherapy combined with nivolumab.

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 2 will receive Nivolumab (every 2 weeks for two doses, and then every 4 weeks) plus radiation therapy (total 5 sessions)

Group II: Cohort 1Experimental Treatment1 Intervention

Subjects will receive standard dose FOLFOX plus nivolumab 240mg IV every 2 weeks for 2 months. If you are responding to treatment, you will receive FOLFOX plus nivolumab for one additional month and then you will be randomized to Cohort 1 or Cohort 2. Subjects in Cohort 1 will receive Nivolumab alone (every 2 weeks for two doses, and then every 4 weeks)

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

🇺🇸 Approved in United States as Opdivo for: