MedTrace Logo

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)

NCT02564263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2023-03-13

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Esophageal Carcinoma
  • Esophagogastric Junction Carcinoma

Interventions

BIOLOGICAL

pembrolizumab

200 mg administered as IV infusion on Day 1 of every 21-day cycle

DRUG

paclitaxel

80-100 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle

DRUG

docetaxel

75 mg/m\^2 administered as IV infusion on Day 1 of every 21-day cycle

DRUG

irinotecan

180 mg/m\^2 administered as IV infusion on Day 1 of every 14-day cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2018-10-15
Completion
2022-03-14
FDA Drug
Yes

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02564263 on ClinicalTrials.gov