A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma
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 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 brentuximab vedotin.
• 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 and meets one of the following criteria:
a. Has failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT). Participants must not have had previous treatment with brentuximab vedotin.
b. Is not an auto-SCT candidate due to: chemo-resistant disease (unable to achieve CR or PR to salvage chemotherapy), advanced age (≥65 years of age), or any significant coexisting medical condition (cardiac, renal, pulmonary, or hepatic dysfunction) likely to have a negative impact on tolerability of auto-SCT. Participants <65 years of age who refuse auto-SCT are not eligible for this study. Note: Sponsor review and approval of participants <65 years of age who are not auto-SCT candidates are required before randomization. Participants must have received at least 2 prior multi-agent chemotherapy regimens that did not include brentuximab vedotin.
• Has measureable disease defined as ≥1 lesion that can be accurately measured in at least 2 dimensions with spiral computed tomography (CT) 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 or newly obtained biopsy at Screening (Visit 1).
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
John Godwin, M.D.
- Oncology and Hematology Care Eastside
- Oncology and Hematology Care Newberg
- Oncology and Hematology Care Westside