Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer
NCT03044613 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-03-23
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.
Conditions
- Gastric Cancer
- Esophageal Cancer
- GastroEsophageal Cancer
Interventions
- DRUG
-
240mg or 1 mg/kg administered IV
- DRUG
-
80mg administered IV
- DRUG
-
standard care dose
- DRUG
-
standard care dose
- RADIATION
-
Radiation
standard care dose
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
lead OTHER
Principal Investigators
-
Vincent Lam, MD · Johns Hopkins University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-11
- Primary Completion
- 2027-03-31
- Completion
- 2027-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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