Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
Description
Brief Summary
The purpose of this study is to determine whether an investigational immuno-therapy
combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
participants of this trial will comprise of patients who have relapsed or did not respond to
treatment and are not eligible for stem cell transplant
Phase
N/AInclusion and Exclusion Criteria
- Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:. i) Autologous stem cell transplant (ASCT) ineligible patients. ii) Patients after failure of ASCT.
- Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan. Exclusion Criteria
- Known central nervous system lymphoma.
- Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).
- Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Sites
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