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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT03933449
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • pembrolizumab — BIOLOGICAL
    IV infusion
  • paclitaxel — DRUG
    IV infusion
  • docetaxel — DRUG
    IV infusion
  • irinotecan — DRUG
    IV infusion

Study Details

In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.

Key Dates

Start date
Dec 29, 2016
Status verified
Mar 2023
Primary completion
Feb 13, 2019
Completion
Mar 14, 2022

Study Design

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

Arms

  • Experimental: Pembrolizumab
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to \~2 years). Participants who complete the first course of up to 35 administrations of pembrolizumab (\~2 years) but progress after discontinuation, may be eligible for a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 of each 3-week cycle for up to 17 cycles (up to \~1 year).
  • Active Comparator: Chemotherapy
    Participants receive Investigator's choice of chemotherapy: 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 \~2 years).

Primary Outcome Measure

Overall Survival (OS) in All Participants [ Time Frame: From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to ~24 months) ]

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