Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT02564263
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pembrolizumab — BIOLOGICAL
    200 mg administered as IV infusion on Day 1 of every 21-day cycle
  • paclitaxel — DRUG
    80-100 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle
  • docetaxel — DRUG
    75 mg/m\^2 administered as IV infusion on Day 1 of every 21-day cycle
  • irinotecan — DRUG
    180 mg/m\^2 administered as IV infusion on Day 1 of every 14-day cycle

Study Details

In this study, participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that had progressed after first-line standard therapy were randomized to receive either pembrolizumab (MK-3475) OR the Investigator's choice of standard chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary study hypothesis was that treatment with pembrolizumab would prolong overall survival (OS) as compared to treatment with standard chemotherapy.

Key Dates

Start date
Dec 1, 2015
Status verified
Feb 2023
Primary completion
Oct 15, 2018
Completion
Mar 14, 2022

Study Design

Enrollment
628 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab
    Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).
  • Active Comparator: Chemotherapy
    Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).

Primary Outcome Measure

Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus [ Time Frame: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months) ]

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