Clinical Trial: Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170)

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

Official Title: A Phase II Study of Pembrolizumab (MK-3475) in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) or Relapsed or Refractory Richter Syndrome

Brief Summary: In this study, participants with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL) or relapsed or refractory Richter Syndrome (rrRS) will receive pembrolizumab (MK-3475). The efficacy of pembrolizumab in the treatment of rrPMBCL and rrRS will be evaluated.

Detailed Summary: Treatment with pembrolizumab will continue for a maximum of 35 administrations (approximately 2 years) or until documented disease progression by investigator assessment, unacceptable adverse event(s) (AEs), intercurrent illness that prevents further administration of treatment, participant withdraws consent, pregnancy of the participant, noncompliance with study treatment or procedure requirements, or administrative reasons.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Objective Response Rate (ORR) by Independent Central Review [ Time Frame: Up to 2 years ]

Original Primary Outcome: Overall Response Rate (ORR) by Independent Central Review [ Time Frame: Every 12 weeks for up to 2 years ]

Current Secondary Outcome:

  • ORR by Investigator Assessment [ Time Frame: Up to 2 years ]
  • Progression Free Survival (PFS) by Independent Central Review and Investigator Assessment [ Time Frame: Up to 2 years ]
  • Duration of Response (DOR) by Independent Central Review and Investigator Assessment [ Time Frame: Up to 2 years ]
  • Disease Control Rate (DCR) by Independent Central Review and Investigator Assessment [ Time Frame: Up to 2 years ]
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]
  • Number of Participants Who Experience an AE [ Time Frame: Up to 27 months ]
  • Number of Participants Who Discontinue Study Drug Due to an AE [ Time Frame: Up to 2 years ]


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: October 14, 2015
Date Started: December 2, 2015
Date Completion: September 19, 2018
Last Updated: April 26, 2017
Last Verified: April 2017