A Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab in Relapsed or Refractory B-Cell Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Hematologic Neoplasms

In brief

The primary objective of this study is to characterize the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of relatlimab administered alone or in combination with nivolumab to subjects with relapsed or refractory B-cell malignancies. Co-primary objective is to investigate the preliminary efficacy of relatlimab in combination with nivolumab in subjects with relapsed or refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffused Large B Cell lymphoma (DLBCL)

Key facts

Study ID

NCT02061761

Run by

Bristol-Myers Squibb

People needed

106

Starts

2014-03-13

Expected to finish

2022-02-16

Last updated by the study team

2023-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologic or cytologic confirmation of chronic lymphocytic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, or Multiple Myeloma and have relapsed following prior treatment or been refractory to prior treatment
• Must have progressed or been refractory to, at least one prior standard therapy, including radiation, immunomodulatory agents (eg, lenalidomide), immunotherapy, cytotoxic chemotherapy, and select antibody (anti-CD20, alemtuzumab, or anti-CD30) therapy.
• Must be more than 100 days post autologous transplant

You may not qualify if…

• Known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease (controlled CNS metastases are allowed)
• Known or suspected autoimmune disease
• History of allergy to anti-PD-1 or anti-PD-L1 antibody therapy or to other monoclonal antibodies or related compounds or to any of their components
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0007 — Baltimore, Maryland, United States
• Local Institution - 0004 — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Local Institution - 0010 — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• Local Institution - 0002 — Portland, Oregon, United States
• Local Institution - 0006 — Houston, Texas, United States
• Local Institution - 0001 — Seattle, Washington, United States
• Local Institution - 0011 — Vancouver, British Columbia, Canada
• Local Institution - 0012 — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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