An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas (CheckMate 436)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Non-Hodgkin's Disease

Treatments

Drug: Brentuximab Vedotin

Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02581631

CA209-436

2015-003286-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).

Enrollment

145 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
Expression of CD30
Subjects must be 18 years or older (≥ 15 years for PMBL)

Exclusion Criteria:

Known central nervous system (CNS) lymphomas; Active cerebral/meningeal disease related to the underlying malignancy
Active, known, or suspected autoimmune disease