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Checkpoint Inhibitor

Nivolumab + Radiation for Gastroesophageal Cancer

Phase 2

Waitlist Available

Led By Manish Shah, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

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

Must have

Age > 18 years

Subjects with a diagnosis of advanced unresectable or metastatic gastroesophageal adenocarcinoma (eg. gastric, gastroesophageal junction, and esophageal adenocarcinoma)

Must not have

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

HER2 positive adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if nivolumab alone or with radiation therapy can help people with cancer who didn't respond to initial treatment with FOLFOX and nivolumab.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation of organs like lungs or intestines; skin reactions; liver problems; hormonal gland issues like thyroid dysfunction; fatigue; infusion reactions and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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

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

Exclusion Criteria

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

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

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My cancer is HER2 positive adenocarcinoma.

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I am currently on medication for an infection.

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

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

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I have an active tuberculosis infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients with 12-month progression free survival

Secondary study objectives

Number of subjects who receive short course chemotherapy with immunotherapy that achieve 12-month progression free survival

Occurrence of Significant Toxicity, as measured by Number of Grade 3 and Grade 4 Adverse Events (Combined) Attributable to Immunotherapy

Overall Survival, as measured by the rate of survival in patients

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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)

0 / 10Eligibility criteria met