A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT04317066
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg by intravenous (IV) infusion, given on day 1 of each 3-week cycle.

Study Details

The purpose of this study is to evaluate the objective response, safety, and tolerability of pembrolizumab in Japanese participants who have refractory primary mediastinal large B-cell lymphoma.

Key Dates

First listed
Mar 20, 2020
Start date
Jun 26, 2020
Status verified
Mar 2025
Primary completion
Apr 11, 2024
Completion
Apr 11, 2024

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab in Participants with rrPMBCL
    Participants with relapsed or refractory primary mediastinal large B-cell lymphoma (rrPMBCL) receive Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 3-week cycle for up to 35 cycles (approximately 2 years).

Primary Outcome Measure

Objective Response Rate (ORR) Using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma as Assessed by Independent Central Review [ Time Frame: Up to approximately 24 months ]

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