NCT03044613

Nivolumab +/- Relatlimab Prior to Chemoradiation With II/III Gastro/Esophageal Cancer

Phase IB Trial of Induction Nivolumab or Nivolumab/Relatlimab Prior to Concurrent Chemoradiation in Patients With Operable Stage II/III Esophageal/ Gastroesophageal Junction Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Esophageal Cancer
• GastroEsophageal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	240mg or 1 mg/kg administered IV
DRUG	Relatlimab	80mg administered IV
DRUG	Carboplatin	standard care dose
DRUG	Paclitaxel	standard care dose
RADIATION	Radiation	standard care dose

Timeline

• Start date: 2017-07-11
• Primary completion: 2027-03-01
• Completion: 2027-08-01
• First posted: 2017-02-07
• Last updated: 2026-03-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study