First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)

Official Title

A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

Summary:

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The primary efficacy hypotheses are that both progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 and determined by blinded independent central review, and overall survival (OS) are superior with pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in all participants as well as participants whose tumours are programmed cell death-ligand 1 (PD-L1)-positive.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 in all participants
  • PFS per RECIST Version 1.1 in PD-L1 biomarker-positive participants
  • Overall Survival (OS) in all participants
  • OS in PD-L1 biomarker-positive participants
Secondary Outcome:
  • Objective Response Rate (ORR) per RECIST 1.1 in all participants
  • ORR per RECIST 1.1 in PD-L1 biomarker-positive participants
  • Duration of Response (DOR) per RECIST 1.1 in all participants
  • DOR per RECIST 1.1 in PD-L1 biomarker-positive participants
  • Number of participants with an adverse event (AE)
  • Number of participants discontinuing study treatment due to an AE
  • Change from baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Score
  • Change from baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Score

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society