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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Esophageal AdenocarcinomaGastroesophageal 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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11570

Memorial Sloan Kettering Rockville Centre, Rockville Centre

11725

Memorial Sloan Kettering Commack, Commack

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07645

Memorial Sloan Kettering Bergen, Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER