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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07281924 | Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis | PHASE1 | RECRUITING | 15 | — | — | Jun 1, 2026 | Dec 1, 2030 | May 29, 2026 | 1 | United States |
A DLT is defined as any grade 4+ non-hematologic event lasting greater than 3 days (despite appropriate medical management) considered possibly related to study treatment (HEPZATO KIT™ or Opdualag™) within 12 weeks of Cycle 1 Day 1.
The objective response rate is the proportion of all participants with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).
| Arm | Type | Description |
|---|---|---|
| Participants with Metastatic Melanoma | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Nivolumab and Relatlimab | DRUG | Relatlimab is a human IgG4 LAG-3 blocking antibody. Nivolumab is a human IgG4 PD-1 blocking antibody. Nivolumab 480 mg and relatlimab 160 mg in a fixed-dose combination will be administered on Day 1 of each 28-day cycle that the participant is on treatment and will be given for up to 2 years from start of treatment. |
| Melphalan | DEVICE | The recommended HEPZATO dose is 3 mg/kg based on ideal body weight (IBW), infusion every 6 to 8 weeks for up to 2 total infusions |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required. * Systemic treatment naïve in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (ant...