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Label indication YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. FDA label
Ipilimumab · 1 trial · 2 indications
The safety and tolerability of APX005M in combination with nivolumab and ipilimumab will be assessed by monitoring the of dose-limiting toxicities (DLTs) . This will be defined by both DLTs and any of the following AEs (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) which occur during the first 9 weeks of ipilimumab + nivolumab + APX005M administration that is not clearly due to a cause other than study medication. DLTs in this study do not include reversible grade 3-4 irAEs, that are acceptable and expected with treatment regimens containing ipilimumab and nivolumab, but do include severe, irreversible, non-endocrine adverse events
This outcome will determine the recommended phase II dose (RP2D) of APX005M in combination with nivolumab and ipilimumab in patients with unresectable or metastatic melanoma or renal cell carcinoma (RCC). The RP2D will be defined as a triplet regimen that does not exceed a grade 3-4 irAE rate of approximately 55% or lead to a significant increase in dose limiting toxicities (DLTs) specific to an ipilimumab + nivolumab containing regimen, particularly those which are severe, irreversible, and non-endocrine related events.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1 (DL1) | EXPERIMENTAL | DL1 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.1mg/kg for the induction phase. After 4 cycles, participants will be treated with 360mg of nivolumab and APX005M every 3 weeks. |
| Dose Level 2 (DL2) | EXPERIMENTAL | DL2 will include ipilimumab at 1mg/kg and nivolumab at 3 mg/kg with APX005M of 0.3mg/kg for the induction phase. After 4 cycles we will treat with 360mg of nivolumab and APX005M every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | Nivolumab 3mg/kg intravenously (IV) every 3 weeks for the first 4 treatments and then will be given at 360mg every 3 weeks thereafter |
| Ipilimumab | DRUG | Ipilimumab 1mg/kg intravenously (IV) every 3 weeks for a total of 4 treatments |
| APX005M | DRUG | APX005M 0.3mg/kg intravenously (IV) every 3 weeks |
Inclusion Criteria: * 1\. At least 1 site of disease must be accessible to provide repeat biopsies for tumor tissue. The biopsy may be waived if not feasible upon discussion with the study PIs. This site may be a target lesion as long as it will not be rendered unmeasurable by the biopsy procedure....
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