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ACTIVE NOT RECRUITING
NCT03776487
PHASE2

Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses thin beams of radiation of different strengths aimed at the tumor from many angles. This type of radiation therapy may reduce the damage to healthy tissue near the tumor. Giving nivolumab, ipilimumab, chemotherapy and radiation therapy may work better in treating patients with gastric cancer.

Official title: Pilot Study of Dual Checkpoint Inhibition Followed by Immuno-Chemoradiation in Patients With Resectable Gastric Adenocarcinoma (Concept ID 2016-NIV-0551)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2019-01-07

Completion Date

2026-12-30

Last Updated

2025-11-03

Healthy Volunteers

No

Conditions

Clinical Stage 0 Gastric Cancer AJCC v8Clinical Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IIB Gastric Cancer AJCC v8Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Gastric AdenocarcinomaLocalized Gastric CarcinomaLocalized Gastroesophageal Junction AdenocarcinomaPathologic Stage 0 Gastric Cancer AJCC v8Pathologic Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage I Gastric Cancer AJCC v8Pathologic Stage IA Gastric Cancer AJCC v8Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IB Gastric Cancer AJCC v8Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIA Gastric Cancer AJCC v8Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIB Gastric Cancer AJCC v8Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8

Interventions

DRUG

Fluorouracil

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Oxaliplatin

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo partial or total gastrectomy and lymphadenectomy

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States