Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

This phase II/III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.

Official Title

A Phase II/III Study of Peri-Operative Nivolumab and Ipilimumab in Patients With Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

Details

Keywords

Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Adenocarcinoma, Esophageal Neoplasms, Paclitaxel, Carboplatin, Nivolumab, Albumin-Bound Paclitaxel, Ipilimumab, Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Radiation Therapy, carboplatin, paclitaxel, radiation therapy, carboplatin, paclitaxel, radiation therapy, nivolumab, nivolumab, ipilimumab

Eligibility

Locations

Details

Status
currently not accepting new patients, but might later
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT03604991
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 278 study participants
Last Updated