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ACTIVE NOT RECRUITING
NCT04021108
PHASE2

Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2019-07-22

Completion Date

2026-06

Last Updated

2025-06-24

Healthy Volunteers

No

Interventions

DRUG

Nivolumab 240 MG

Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.

Locations (5)

Moffitt Cancer Center

Tampa, Florida, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

Roswell Park Cancer Center

Buffalo, New York, United States

Weill Cornell Medicine

New York, New York, United States