Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refract… (NCT02684292) | Clinical Trial Compass
CompletedPhase 3
Study of Pembrolizumab (MK-3475) vs. Brentuximab Vedotin in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-204/KEYNOTE-204)
304 participantsStarted 2016-05-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Has relapsed (disease progression after most recent therapy) or refractory (failure to achieve Complete Response \[CR\] or Partial Response \[PR\] to most recent therapy) classical Hodgkin Lymphoma.
* Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously treated with BV.
* Has measurable disease defined as ≥1 lesion that can be accurately measured in ≥2 dimensions with spiral computed tomography (CT) scan or combined CT/positron emission tomography (PET) scan. Minimum measurement must be \>15 mm in the longest diameter or \>10 mm in the short axis.
* Is able to provide an evaluable core or excisional lymph node biopsy for biomarker analysis from an archival (\>60 days) or newly obtained (within 60 days) biopsy at Screening (Visit 1).
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Has adequate organ function
* Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days (for participants receiving pembrolizumab) or 180 days (for participants receiving BV) after the last dose of study drug.
* Male participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 120 days (for participants receiving pembrolizumab) or 180 days (for participants receiving BV) after the last dose of study drug.
Exclusi…