A Phase II Study of Maintenance Nivolumab Immunotherapy for People with Primary Central Nervous System Lymphoma and Persistent Cerebrospinal Fluid Tumor DNA After Finishing Initial Chemotherapy

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Full Title

Phase II Maintenance Trial of Nivolumab for Newly Diagnosed PCNSL Patients with Persistent Circulating Tumor DNA in the CSF After Completion of Methotrexate-Based First-Line Induction Chemotherapy

Purpose

In this study, researchers want to see if nivolumab immunotherapy is effective for reducing the risk of cancer recurrence in people with primary central nervous system lymphoma (PCNSL) who have evidence of tumor DNA in their cerebrospinal fluid after completing initial chemotherapy with the drug methotrexate. The presence of tumor DNA in the cerebrospinal fluid is an indicator that the cancer might come back. These patients might benefit from an additional treatment, such as immunotherapy, that fights the cancer in a different way than the first therapy.

Patients in this study will receive nivolumab for a year. Nivolumab works by boosting the ability of the immune system to detect and destroy cancer cells. It is approved for several types of cancer; its use in this study is considered investigational. Nivolumab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have PCNSL with evidence of tumor DNA (“cell-free DNA”) in the cerebrospinal fluid following completion of first-line therapy with methotrexate.
  • At least 2 weeks must pass between the completion of previous treatments and receipt of the first dose of nivolumab.
  • Prior treatment with immunotherapy is not permitted.
  • 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.

For more information about this study and to inquire about eligibility, please contact Dr. Christian Grommes at 212-639-4058.

Protocol

19-383

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators