Bristol-Myers Squibb, Pharmacyclics and Janssen R&D have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of BMS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor co-developed and co-marketed by Pharmacyclics and Janssen.

The phase I/II study will focus on evaluating the safety and anti-tumor activity of combining Opdivo and Imbruvica as a potential treatment option for patients with non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). BMS has proposed the name Opdivo, which, if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab.

Opdivo is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; preclinical evidence suggests Opdivo and Imbruvica may have the potential for additive treatment effects in patients with hematologic malignancies.

The study will be conducted by Janssen.