Spots Global Cancer Trial Database for Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer
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Trial Identification
Brief Title: Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer
Official Title: Phase IB Trial of Induction Nivolumab or Nivolumab/Relatlimab Prior to Concurrent Chemoradiation in Patients With Operable Stage II/III Esophageal/ Gastroesophageal Junction Cancer
Study ID: NCT03044613
Study Description
Brief Summary: 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.
Detailed Description: This is a Phase IB study assessing the safety of 2 cycles of induction (Arm A) nivolumab or (Arm B) 2 cycles of induction nivolumab prior to concurrent chemoradiation plus nivolumab (Arm A) or nivolumab/relatlimab (Arm B) before surgical resection in operable stage II/III esophageal/gastroesophageal junction cancer. Approximately 32 patients will be enrolled on study with 16 enrolled on Arm A and if no unexpected toxicities then an additional 16 patients will be enrolled on Arm B.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Johns Hopkins University, Baltimore, Maryland, United States
Alleghany Health Network, Pittsburgh, Pennsylvania, United States
Baylor University/ Charles A. Sammons Cancer Center, Dallas, Texas, United States
Contact Details
Name: Vincent Lam, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
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