Full TitleA 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]
The purpose of this study is to evaluate the safety and effectiveness of giving both brentuximab vedotin and nivolumab immunotherapy in patients with recurrent or persistent non-Hodgkin lymphoma.
Brentuximab is already approved for treating Hodgkin lymphoma and anaplastic large cell lymphoma. It has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug) that kills the cancer.
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; its use in this study for non-Hodgkin lymphoma and in combination with brentuximab is considered investigational.
Both drugs are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CD30-positive non-Hodgkin lymphoma that has continued to grow or came back despite prior therapy.
- Patients must recover from the serious side effects of previous treatments before entering the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.