Nivolumab + Radiation for Gastroesophageal Cancer

Recruiting at 4 trial locations

Overseen By Carina Puello, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must be taking: FOLFOX, Nivolumab

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: HER2 positive, Active TB, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

80 Participants Needed

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.

Research Team

Manish Shah, MD

Principal Investigator

Weill Medical College of Cornell University

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

Absolute neutrophil count ≥ 1,500/mL

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.

Exclusion Criteria

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

My cancer is HER2 positive adenocarcinoma.

I was treated for cancer other than prostate or skin cancer less than 3 years ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive FOLFOX plus nivolumab for 2 months. If stable disease is observed, treatment continues for an additional month.

3 months

Every 2 weeks

Randomized Treatment

Participants are randomized to receive either nivolumab alone or nivolumab plus radiation therapy.

1 month

Every 2 weeks for two doses, then every 4 weeks

Maintenance Therapy

Participants who remain on study receive nivolumab 480 mg every 4 weeks.

20 months

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 months

Treatment Details

Interventions

• Nivolumab

Trial Overview 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.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania