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KeyLARGO for Gastro-esophageal Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study learn about the good and bad side effects pembrolizumab, oxaliplatin, and capecitabine has on you and your cancer.

What is the Condition Being Studied?

Esophageal/ Stomach Cancer

Who Can Participate in the Study?

Adults who:
- Are diagnosed with recurrent (metastatic) cancer (adenocarcinoma) of the esophagus or stomach
- Are HER2 Negative unless you cannot take Herceptin
- Have not had any prior treatment for their cancer, with a few exceptions

Age Group
Adults

What is Involved?

The study will be done in two stages:

Stage 1 is a safety study to make sure the study drug is safe and doesn't cause too many bad side effects.

Stage 2 is a dose expansion study where the study drug will be given to a higher number of subjects to make sure the study drug is safe and doesn't cause too many bad side effects.

If you choose to join this study, you will:
- Get pembrolizumab and oxaliplatin into a vein on day 1 of each 21 days and Capecitabine by mouth on days 1-14 of each 21 day cycle.
- Have routine clinic visits to check you and your cancer

Study Details

Full Title
A Single Arm, Phase II Study of Pembrolizumab, Oxaliplatin, and Capecitabine in the First Line Treatment of Patients with Gastro-esophageal Cancer (KeyLARGO)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00080566
NCT:NCT03342937
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698