A Phase 1/2a Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the Combination of Ibrutinib with Nivolumab in Subjects with Hematologic Malignancies
Ibrutinib is an anticancer drug used to treat lymphoma and chronic lymphocytic leukemia. It works by blocking a protein inside lymphoma cells called Bruton's tyrosine kinase (BTK), which helps lymphoma cells to live and grow.
Nivolumab is a form of immunotherapy. It boosts the body's immune system by targeting a protein on white blood cells called PD-1. PD-1 normally maintains the balance of the immune system by shutting it down at the right time. Some cancers take advantage of this mechanism by expressing PD-L1, enabling them to escape attack by the body's white blood cells. Nivolumab blocks PD-1, enhancing the body's ability to detect and destroy cancer cells. It is approved for treating several types of cancer.
In this study, researchers want to find the best dose of these two drugs that can be given together in patients with chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), or diffuse large B-cell lymphoma (DLBCL) that continues to grow despite other treatment. Ibrutinib is taken by mouth, while nivolumab is given intravenously.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CLL, FL, or DLBCL that has continued to grow despite at least one but no more than four prior regimens of treatment.
- Patients must have recovered from the serious side effects of prior therapies before entering the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.