This phase II trial studies how well nivolumab works for the treatment of hematological malignancies that have come back (relapsed), does not respond (refractory), or is detectable after CAR T cell therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
OUTLINE: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Given IV
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Best Overall Response Rate (ORR)
Assessed by disease-specific guidelines: multiple myeloma - International Myeloma Working Group response criteria, non-Hodgkin lymphoma - Response assessment will be based on the Lugano Criteria, and chronic lymphocytic leukemia - Response assessment based on the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria. ORR will be estimated, and its corresponding 95% exact binomial confidence interval (CI) will be provided.
Time frame: Up to 1 year 8 months
Overall Survival
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Time frame: From the first study drug administration to death from any cause, up to 5 years
Progression-free Survival
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Time frame: From first study drug administration to the first occurrence of disease progression or death from any cause, assessed up to 5 years
Duration of Response
Will employ Kaplan-Meier and Cox proportional hazard model methodology.
Time frame: Up to 5 years
Incidence of Adverse Events
Will be determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Safety data will be summarized descriptively. Adverse events will be summarized by severity, seriousness, and relationship to study drug.
Time frame: Up to 30 days after the last dose of study drug, up to a maximum of 1 year 9 months
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