Study of Pembrolizumab Versus Placebo in Patients with Esophageal Cancer Receiving Chemotherapy and Radiation

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04210115

Provider View

This clinical trial is comparing the effects of adding pembrolizumab, an immunotherapy drug, to standard chemotherapy and radiation treatment for esophageal cancer, against a placebo. The study aims to see if this combination improves survival and delays cancer progression.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding pembrolizumab to standard chemotherapy and radiation therapy can improve outcomes for patients with esophageal cancer. Researchers are looking at how well this combination works in extending the time patients live without their cancer getting worse and overall survival rates. The study focuses on patients whose tumors have certain levels of a protein called PD-L1, as well as all participants regardless of PD-L1 levels.

Description

Participants in this study will receive either pembrolizumab or a placebo, along with one of two chemotherapy regimens and radiation therapy, for up to about one year. The chemotherapy options include:

  • FP: 5-fluorouracil (5-FU) and cisplatin
  • FOLFOX: 5-FU, oxaliplatin, and leucovorin or levoleucovorin.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of esophageal cancer that cannot be removed by surgery.
  • Suitable for chemotherapy and radiation therapy.
  • Not expected to need surgery during the study.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate organ function.
  • Male participants must use effective contraception and avoid donating sperm during and after treatment.
  • Female participants must use effective contraception, not be pregnant or breastfeeding, and avoid donating eggs during and after treatment.

Exclusion Criteria

  • Tumor has invaded nearby organs or major blood vessels.
  • Recent major surgery or need for major surgery during the study.
  • Significant weight loss in the past 3 months.
  • Previous chemotherapy or radiation for esophageal cancer.
  • Recent heart attack or heart failure.
  • Previous treatment with certain immunotherapy drugs.
  • Recent live vaccine.
  • Active infections or immune system issues.
  • Other active cancers requiring treatment in the past 3 years.
  • Severe allergies to study drugs.
  • Active autoimmune diseases needing treatment in the past 2 years.
  • History of lung inflammation requiring steroids.
  • Active infections needing treatment.
  • History of HIV, Hepatitis B or C, or tuberculosis.
  • Pregnant or breastfeeding, or planning to conceive during the study.
  • Previous organ transplant.

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