The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug called nivolumab. This study will determine the safety in subjects that receive nivolumab when given in combination with daratumumab, or dartartumumab alone in relapsed and/or refractory multiple myeloma.
Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body’s immune system to work against tumor cells. It has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced lung and kidney cancers.
Daratumumab is a human CD38-directed monoclonal antibody and is approved as monotherapy for third line treatment of MM patients who failed prior therapy.
Another purpose of this study is to evaluate the low-level disease in your blood, urine and bone marrow (minimal residual disease), percentage of patients whose cancer shrinks or disappears after treatment (overall response rate), how long your body responds (duration of response), how long you stay free of disease (progression free survival), your bodies immune response to nivolumab, and how nivolumab works in body.
BMS hopes to use the data from this study together with data from other clinical studies using these investigational drugs to determine the most effective combination of nivolumab for further study.
SparkCures ID | 222 |
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Trial Phase | Phase 1/2 |
Enrollment | 60 Patients |
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The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Please visit the ClinicalTrials.gov page for historical site information.
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