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A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants with Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

Clinical Trial Details

The purpose of this study is to:

  • Test how well the study drug pembrolizumab (MK-3475) works with definitive chemoradiotherapy (dCRT) as compared to placebo (a look-alike with no active ingredients) with dCRT in patients with esophageal carcinoma. dCRT combines chemotherapy and radiation therapy to increase the effects of both.
  • See if pembrolizumab and dCRT slows cancer growth and helps you live longer compared to placebo and dCRT.
  • Test the safety of the study drug when combined with dCRT.
  • See how your body responds the study drug when combined with dCRT.

Pembrolizumab (MK-3475), also known as KEYTRUDA®, is a humanized monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including cancer cells) that is given intravenously and acts as a checkpoint inhibitor (a molecule that blocks protein binding on immune cells) to allow your immune system to participate in tumor cell destruction. It has not been approved to treat your type of esophageal cancer, but it is approved to treat other types of cancer. It has been approved by certain health authorities, such as the Food and Drug Administration (FDA), for the treatment of various cancers (i.e. lung cancer, melanoma); however, it may not be approved for your exact type of cancer.

The chemotherapies that can be used in this study are FOLFOX and FP. FOLFOX is a combination of the chemotherapy drugs 5-fluorouracil, oxaliplatin, and leucovorin/calcium folinate/folinic acid or levoleucovorin/calcium levofolinate/levofolinic acid. FP is a combination of cisplatin and 5-fluorouracil (5-FU). You will be receiving FOLFOX. Chemotherapies are approved by the FDA as treatment for your type of esophageal cancer. Chemotherapy drugs kill or disable cancer cells.

Chemotherapies can be combined with various doses of radiation therapy in this study. You will be receiving dose of 50 Gy.

The combination of pembrolizumab and FOLFOX or FP are considered experimental. Experimental means that this use was not approved by the FDA for treatment of your type of cancer.

Key Eligibility: 
  • Open to men and women above the age of 18 with esophageal cancer, adenocarcinoma of the esophagogastric junction (EGJ), or esophageal adenocarcinoma (EAC)
  • Is deemed suitable for dCRT, has disease that is qualitatively evaluable upon radiographic assessment by local site Investigator, and is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist
  • Has an ECOG performance status of 0 to 1 within 3 days of the first dose of study intervention.

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


June Greenberg, RN
(212) 746-2651

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group