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

  • Interventional
  • Not Recruiting
  • NCT02581631
Eligibility Details Visit Clinicaltrials.gov

A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination With Brentuximab Vedotin in Subjects With Relapsed Refractory Non Hodgkin Lymphomas With CD30 Expression (CheckMate 436: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 436)

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).

Gender
All

Age Group
15 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02581631

IRB#IRB15-1443

Lead SponsorBristol-Myers Squibb

Lead PhysicianJustin P. Kline

Collaborator(s)N/A

EligibilityAll
15 Years and up
Not Recruiting