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Nivolumab and Ipilimumab in Treating Patients With Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

NCT03604991 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • 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

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood sample

DRUG

Carboplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

DRUG

Paclitaxel

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET scan

RADIATION

Radiation Therapy

Undergo radiation therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jennifer R Eads · ECOG-ACRIN Cancer Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-03
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604991 on ClinicalTrials.gov