Clinical Trials Logo
  1. Home
  2. Esophageal Carcinoma
  3. NCT03933449

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

Esophageal Carcinoma Clinical Trial

Official title:
A Phase III Randomized Open-Label Study of Single Agent Pembrolizumab vs Physicians' Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects With Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus That Have Progressed After First-Line Standard Therapy (KEYNOTE-181)

Clinical Trial Summary

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.

Clinical Trial Description

The China extension study will include participants previously enrolled in China in the global study for MK-3475-181 (NCT02564263) plus those enrolled during the China extension enrollment period. Per protocol, response/progression or adverse events during the second pembrolizumab course will not be counted towards efficacy outcome measures or safety outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03933449
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact
Status Completed
Phase Phase 3
Start date December 29, 2016
Completion date March 14, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Not yet recruiting NCT05996484 - Neoadjuvant Therapy of Anlotinib Combined With Toripalimab and Chemotherapy for Resectable Esophageal Carcinoma Phase 2
Recruiting NCT02355249 - Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer Phase 3
Completed NCT01691625 - Concurrent Chemoradiation With or Without DC-CIK Immunotherapy in Treating Locally Advanced Esophageal Cancer N/A
Not yet recruiting NCT05937438 - Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Carcinoma Phase 1/Phase 2
Recruiting NCT05777707 - Neoadjuvant Therapy of PD-1 Blockade Combined With Chemotherapy for Esophageal Carcinoma Phase 1/Phase 2
Recruiting NCT02527057 - Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer N/A
Withdrawn NCT00636298 - Study of Cetuximab and Bevacizumab in Cancer of the Esophagus After Failure of Patient's First Therapy Phase 2
Recruiting NCT06009705 - Toripalimab Combined With Radiotherapy and S-1 for Older Patients With Esophageal Cancer
Recruiting NCT04652180 - Robot-assisted Thoracic Approach Versus Open Transthoracic Esophagectomy . N/A
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Withdrawn NCT03220009 - Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma Phase 2
Recruiting NCT06199895 - Clinical Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Patients With Taxans-resistant Pancreatic Adenocarcinoma, Cholangiocarcinoma, Lung Cancer, Gastric Cancer, Esophageal Carcinoma, or Breast Cancer Phase 2
Completed NCT00590031 - Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan. Phase 2
Active, not recruiting NCT00176800 - Chemoradiation and Tetrathiomolybdate (TM) in Patients With Esophageal Carcinoma Phase 2
Completed NCT03099382 - Study of SHR-1210 Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal Cancer Phase 3
Active, not recruiting NCT04607590 - Yoga Program for Improving the Quality of Life in Couples Coping With Cancer
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Completed NCT01855854 - Second-line Treatment With Icotinib in Esophageal Carcinoma Patients With EGFR Overexpression (IHC 3+) or Positive FISH Phase 2
Recruiting NCT06265285 - Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program Phase 2