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Multicenter, Randomized Phase II Study of Pembrolizumab in Combination with Chemotherapy and Chemoradiation in Locally Advanced Esophageal Adenocarcinoma

Clinical Trial Details

This clinical trial is for men and women with locally advanced esophageal adenocarcinoma. This study will test the safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma.

Eligible patients will be randomized to either Cohort 1 or Cohort 2. Patients in Cohort 1 will receive induction chemotherapy followed by chemoradiation while patients in Cohort 2 will receive induction chemotherapy plus pembrolizumab followed by chemoradiation. Patients in both cohorts will then go on to have a resection followed by pembrolizumab. The treatment phase will last up to approximately 14 weeks and the post-surgery phase will last up to approximately 12 months. It is expected that patients will be randomized over approximately 18 months. 

Key Eligibility: 

   • Men and women age 18 and older 
   • Diagnosis of esophageal or GEJ Siewert type I or II adenocarcinoma 
   • No prior anti-cancer treatment, including chemotherapy, radiation or monoclonal antibody 
   • Detailed eligibility reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Sabrina Machado, RN
(646) 962-3378
sam4006@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1602016966

Status

Open to Enrollment

Age Group

Adult

Sponsor