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| ID | Type | Description | Link |
|---|---|---|---|
| UW25072 | Other Identifier | OnCore ID | |
| Protocol Version 9/26/25 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/HEM-ONC | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Delcath Systems Inc. | INDUSTRY |
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This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in the first line setting in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.
Co-Primary Objectives
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Metastatic Melanoma | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Dose Limiting Toxicities (DLTs) | 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. | up to 12 weeks |
| Incidence of Treatment-Emergent Adverse Events | up to 2 years | |
| Incidence of Serious Treatment-Emergent Adverse Events | up to 2 years | |
| Number of Participants that Discontinue Treatment due to Adverse Events | up to 2 years | |
| Overall Response Rate (ORR) | 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). | After treatment plus follow up for 2 years (up to 4 years) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR in Hepatic and Non-Hepatic Lesions | The proportion of all participants with confirmed PR or 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) in Hepatic and Non-Hepatic Target Lesions. | After treatment plus follow up for 2 years (up to 4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer Connect | Contact | 800-622-8922 | clinicaltrials@cancer.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Ma, MD | UW Carbone Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Hospital and Clinics | Recruiting | Madison | Wisconsin | 53792 | United States |
Researchers must have local IRB approval for their study that is to include study of the biospecimens and accompanying data. Release of biospecimens to non-UW researchers will be performed according to all UW regulatory policies. Tissue (including blood) specimen as part of this research will be primarily stored at UW and may be sent to an outside lab/facility to achieve the objectives of the study. No study data or patient health information will be shared with a third party.
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Researchers who are doing biomedical research may apply to the PI for access to blood and tissue (no patient identifiers on tubes or slides). Only de-identified information will be released with the specimens
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000721227 | relatlimab |
| C000729737 | Opdualag |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Five patients will be treated first. If at least two achieve an objective response and no more than two experience a DLT, an additional ten patients will be enrolled, giving a total sample of fifteen. If the first 5 participants records three or more DLTs, or one or fewer responses, the trial will halt.
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| 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 |
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| Disease Control Rate (DCR) | The disease control rate is the proportion of all subjects with SD for 8 weeks, or PR, or 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). | After treatment plus follow up for 2 years (up to 4 years) |
| Progression Free Survival (PFS) | A measurement from the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs. Participants who have not progressed will be right-censored at the date of the last disease evaluation. | After treatment plus follow up for 2 years (up to 4 years) |
| Overall Survival (OS) | Overall survival is defined by the date of randomization to date of death from any cause. | After treatment plus follow up for 2 years (up to 4 years) |
| Duration of Response (DOR) | Duration of overall response-the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). | After treatment plus follow up for 2 years (up to 4 years) |
| Number of Participants with Tumor Reduction at any time | After treatment plus follow up for 2 years (up to 4 years) |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |