Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02684292|
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : February 28, 2019
The purpose of this study is to evaluate pembrolizumab (MK-3475) in the treatment of participants with relapsed or refractory Classical Hodgkin Lymphoma. Participants will be randomized to receive either pembrolizumab or brentuximab vedotin (BV) for up to 35 three-week cycles of treatment.
The primary hypotheses of this study are that treatment with pembrolizumab prolongs Progression-free Survival (PFS) and Overall Survival (OS) in participants with relapsed or refractory Classical Hodgkin Lymphoma compared to treatment with BV.
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma||Biological: pembrolizumab Biological: brentuximab vedotin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma|
|Actual Study Start Date :||May 23, 2016|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||December 30, 2023|
Participants receive pembrolizumab 200 mg administered intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles.
Active Comparator: Brentuximab vedotin
Participants receive BV 1.8 mg/kg (maximum 180 mg per dose) IV on Day 1 of each 3-week cycle for up to 35 cycles.
Biological: brentuximab vedotin
Other Name: ADCETRIS®
- Progression-free Survival (PFS) [ Time Frame: Up to approximately 40 months ]
- Overall Survival (OS) [ Time Frame: Up to approximately 40 months ]
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 40 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684292
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|