A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed / Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,

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

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)

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

• Primary ID CA209-812
• Secondary IDs NCI-2017-01275, 2017-000847-41
• Clinicaltrials.gov ID NCT03138499