Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab · 1 trial · 1 indication
A DLT is defined as one of the following toxicities: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/µL) lasting 5 days or more. * Grade 3 to 4 thrombocytopenia associated with bleeding requiring platelet transfusion * Cardiac dysfunction: Grade \> 3 left ventricular systolic dysfunction or grade \> 2 myocarditis * Any grade 3-4 treatment-emergent non-hematologic adverse event (AE) clearly unrelated to the underlying disease and considered to be at least possibly related to protocol therapy
The Escalation with Overdose Control (EWOC) design will be used to identify the MTD.
A DLT is defined as one of the following toxicities: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/µL) lasting 5 days or more. * Grade 3 to 4 thrombocytopenia associated with bleeding requiring platelet transfusion * Cardiac dysfunction: Grade \> 3 left ventricular systolic dysfunction or grade \> 2 myocarditis * Any grade 3-4 treatment-emergent non-hematologic adverse event (AE) clearly unrelated to the underlying disease and considered to be at least possibly related to protocol therapy
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm 2 | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Arm 3 (expansion) | EXPERIMENTAL | Patients receive dexamethasone IV on days 1, 2, 8, 9, 15, and 16, pelareorep IV on days 1, 2, 8, 9, 15, and 16, carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16, and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib | DRUG | Given IV |
| Dexamethasone | DRUG | Given IV |
| Nivolumab | BIOLOGICAL | Given IV |
| Pelareorep | BIOLOGICAL | Given IV |
Inclusion Criteria: * Patient must have multiple myeloma that fits or did fit International Myeloma Working Group (IMWG) diagnostic criteria * In arm 3 but not for arms 1 or 2, patients must have measurable disease defined as any of the following: * Serum monoclonal protein ≥ 0.5 g/dL by protein...
Nivolumab is a monoclonal antibody being studied for the treatment of recurrent plasma cell myeloma, a form of multiple myeloma. It is currently in Phase 1 clinical development as an investigational therapy for this condition.
Nivolumab targets the programmed cell death protein 1 (PD-1) receptor on T cells, which helps the immune system recognize and attack cancer cells. By blocking PD-1, it enhances the body's immune response against tumors.
Nivolumab is being developed by Oncolytics Biotech Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ONCY. The company is conducting clinical trials to evaluate its safety and efficacy.
Nivolumab is in Phase 1 clinical development for recurrent plasma cell myeloma. It is an investigational drug and has not yet been approved by regulatory authorities for this indication.
Nivolumab is being studied in a Phase 1 clinical trial with the identifier NCT03605719. This completed trial enrolled 23 participants and evaluated the combination of dexamethasone, carfilzomib, and nivolumab with pelareorep for relapsed or refractory multiple myeloma.
Nivolumab is the generic name for the drug also known as Opdivo, a PD-1 inhibitor used in cancer immunotherapy. In this context, it is being investigated in combination with other agents for recurrent plasma cell myeloma.