Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04091750 | Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma | PHASE2 | ACTIVE NOT_RECRUITING | 14 | — | — | Mar 2, 2020 | Dec 1, 2026 | Mar 3, 2026 | 3 | United States |
The PFS rate for nivolumab/ipilimumab plus cabozantinib in patients with unresectable advanced melanoma using imRECIST.
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles with Cabozantinib 40mg PO daily for 12 weeks (Induction); Followed by Maintenance therapy: Nivolumab 480mg IV every 4 weeks for up to 92 weeks; Cabozantinib 40mg PO daily for up to 92 weeks; Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled. |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | Induction: 3mg/kg IV every 3 weeks x 4 cycles Maintenance: 480mg IV every 4 weeks for up to 92 weeks |
| Ipilimumab | DRUG | Induction: 1mg/kg IV every 3 weeks x 4 cycles |
| Cabozantinib | DRUG | Induction and Maintenance: 40mg PO daily |
Inclusion Criteria: 1. All patients must have unresectable stage IIIb-IIId or IV melanoma by AJCC 8th edition. Note: Patients with uveal melanoma are excluded from this study. 2. Age \> 18 and ECOG Performance Status of 0 or 1. 3. Measurable disease by RECIST 1.1 4. Baseline tumor specimen availabl...