Immunotherapy + Chemoradiation for Gastroesophageal Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byVincent Lam, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Anti-PD-1 (nivolumab) or Anti-PD1/Anti LAG-3- (relaltimab) administration in the pre-operative setting with chemoradiation will be safe and feasible in patients with resectable distal esophageal/gastroesophageal junction cancer and will change cellular and molecular characteristics of the tumor microenvironment that will improve survival.

Eligibility Criteria

Adults with resectable esophageal or gastroesophageal junction cancer, who have not undergone certain treatments and do not have autoimmune diseases, active infections, or recent heart issues. Participants must meet specific health criteria like normal organ function tests, be able to undergo surgery, and agree to use contraception.

Inclusion Criteria

I can eat and maintain my weight without special feeding tubes or IV nutrition.

I had surgery that allows for my tissue to be tested for specific markers.

My cancer in the esophagus or where it meets the stomach has been confirmed by a biopsy.

+10 more

Exclusion Criteria

I have an autoimmune disease, but it's not one of the exceptions listed.

My esophageal cancer is located in the middle or upper part of my esophagus.

I do not have an active infection, Hepatitis B/C, HIV/AIDS, or allergies to the study drug.

+11 more

Participant Groups

The trial is testing the safety and effectiveness of Nivolumab alone or combined with Relatlimab before chemoradiation therapy in patients preparing for surgery. It aims to see if these drugs can change tumor characteristics to improve survival rates.

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment5 Interventions

Nivolumab 240mg administered IV over 30 minutes followed by relatlimab 80mg administered IV over 60 minutes on Day 1 every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation).

Group II: Arm AExperimental Treatment4 Interventions

Nivolumab 240mg administered IV over 30 minutes every 2 weeks for 2 cycles and then standard of care chemoradiation (weekly carboplatin/paclitaxel and concurrent radiation

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

🇺🇸 Approved in United States as Paraplatin for: