Clinical Trial: Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122, KEYNOTE-122)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Two-arm, Open-label, Randomized Phase II Study of Pembrolizumab (MK-3475) Monotherapy Versus Standard Chemotherapy in Platinum Pre-treated, Recurrent or Metastatic Nasopharyngeal Cancer (NPC) (Keyno

Brief Summary:

This is a study of pembrolizumab (MK-3475) versus standard of care (SOC) treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.

The primary study hypothesis is that pembrolizumab treatment prolongs progression-free survival (PFS) and overall survival (OS) when compared to SOC treatment.


Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Response Rate (ORR) per RECIST 1.1 [ Time Frame: Up to approximately 2 years ]
  • Number of Participants Who Experience One or More Adverse Events (AEs) [ Time Frame: Up to approximately 25 months ]
  • Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to approximately 2 years ]


Original Secondary Outcome: Same as current

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: November 19, 2015
Date Started: April 18, 2016
Date Completion: August 14, 2019
Last Updated: March 22, 2017
Last Verified: March 2017