Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab and Relatlimab · 1 trial · 2 indications
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. * 0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell de...
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Nivolumab and Relatlimab is being studied for the treatment of metastatic melanoma with liver metastases. It is currently in Phase 1 clinical development as an investigational therapy. The combination is being evaluated in a clinical trial to assess its safety and efficacy in patients with this condition.
Nivolumab and Relatlimab is being developed by Delcath Systems, Inc., a company traded under the ticker symbol DCTH. The company is conducting a Phase 1 clinical trial to evaluate this combination therapy for metastatic melanoma with liver metastases.
Nivolumab and Relatlimab is in Phase 1 clinical development. It is an investigational therapy, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the combination in patients with metastatic melanoma and liver metastases.
Nivolumab and Relatlimab is being studied in a single Phase 1 clinical trial with the identifier NCT07281924. The trial, titled 'Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis,' is recruiting 15 participants in the United States. It is an uncontrolled, open-label study.
Nivolumab and Relatlimab is being studied in combination with Opdualag in the clinical trial NCT07281924. The trial evaluates the combination of Hepzato Kit and Opdualag, which includes nivolumab and relatlimab, for metastatic melanoma with liver metastases. The study is in Phase 1.