CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
Pembrolizumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02576990
NCT02576990Phase 2Completed
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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 (rrRS)

Merck Sharp & Dohme LLC·interventional·Posted Oct 15, 2015·Updated Jul 27, 2023

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab for Mediastinal Large B-cell Lymphoma and Richter Syndrome. Completed, enrolled 80 participants.

Detailed 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. The primary study hypothesis is that intravenous (IV) administration of single agent pembrolizumab to the rrPMBCL cohort will result in an Objective Response Rate (ORR) of greater than 15% using the International Working Group (IWG) response criteria (Cheson, 2007) by independent central review. Effective with Protocol Amendment 04, enrollment into the rrRS cohort was closed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMediastinal Large B-cell Lymphoma, Richter Syndrome
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 15, 2015
Enrollment StartDec 2, 2015
Primary CompletionMay 28, 2019
Study CompletionOct 23, 2020
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.7 years ago

Interventions

Pembrolizumabbiological

IV infusion