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, (CheckMate 812)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 3

Conditions: Hodgkin's Disease

Treatments: Biological: Brentuximab vedotin; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03138499

CA209-812

2017-000847-41 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Module A

Experimental group

Description:

Nivolumab combined with Brentuximab

Treatment:

Biological: Nivolumab

Biological: Brentuximab vedotin

Module B

Experimental group

Description:

Brentuximab alone

Treatment:

Biological: Brentuximab vedotin