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Durvalumab, an Anti-PDLI Antibody, and Tremelimumab, an Anti-CTLA4 Antibody, and Chemoradiation Before Surgery for Esophageal Cancer

NCT02962063 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-05

No results posted yet for this study

Summary

The purpose of this study is to test the safety of adding a new drug, durvalumab (also called MEDI4736), to chemoradiation with either FOLFOX/Capeox or carboplatin and paclitaxel, following initial chemotherapy with FOLFOX. The investigators want to find out what effects, good and/or bad, this combination has on the patient and cancer.

Conditions

  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Interventions

BIOLOGICAL

durvalumab

Durvalumab can be given irrespective of CBC, at the discretion of the treating physician.

DRUG

carboplatin AUC 2/paclitaxel

RADIATION

External beam radiation (EBRT)

Radiation will be delivered starting on a Monday or Tuesday between Days 29-30, based on the first induction durvalumab dose administered on Day 1. Patients will be treated 5 days/week at 1.80 Gy/day, to a total planned dose of 41Gy in 23 fractions. Induction Day 15 has a -1/+2 day window, and Day 29 has a -1/+1 day window.

PROCEDURE

esophagogastrectomy

Patients undergo surgical resection 6-10 weeks after the completion of chemoradiation.

DRUG

Tremelimumab

Tremelimumab will be administered once at 300 mg on Day 29 prior to chemoradiation only.

Sponsors & Collaborators

Principal Investigators

  • Geoffrey Ku, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02962063 on ClinicalTrials.gov