Full TitleA Phase I Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Immunoregulatory Activity, and Preliminary Antitumor Activity of Anti-Programmed-Death 1 (PD-1) Antibody ((Nivolumab, BMS 936558) and the combination of Nivolumab and Ipilimumab in Subjects with Relapsed or RefractoryHematologic Malignancy Back to top
The purpose of this study is to find the highest dose of nivolumab (BMS-936558) in patients with multiple myeloma, non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic myelogenous leukemia that persists or has returned despite prior therapy. Nivolumab 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 shut-down mechanism by activating PD-1, enabling them to escape attack by the body’s white blood cells. Nivolumab binds to and inactivates PD-1, enhancing the body’s ability to detect and destroy cancer cells.
Nivolumab is approved for treating melanoma and some metastatic squamous cell lung cancers; its use for treating other cancers is considered investigational. It is given intravenously (by vein).Back to top
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have multiple myeloma, non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic myelogenous leukemia that persists or has returned despite prior therapy.
- Patients must have had at least one prior regimen of chemotherapy.
- At least 3 weeks must have passed since the completion of chemotherapy and entry into 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.
- Patients must be age 18 or older.