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Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

ConditionsMetastatic MelanomaLiver Metastases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.

Evaluable/measurable disease according to RECIST v1.1.

Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.

Disqualifiers

Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)

Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.

History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.

Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Participants with Metastatic MelanomaExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 12 weeks
2

Incidence of Treatment-Emergent Adverse Events

Time frame
up to 2 years
3

Incidence of Serious Treatment-Emergent Adverse Events

Time frame
up to 2 years
4

Number of Participants that Discontinue Treatment due to Adverse Events

Time frame
up to 2 years

Secondary outcomes

1

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.

Time frame
After treatment plus follow up for 2 years (up to 4 years)
2

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).

Time frame
After treatment plus follow up for 2 years (up to 4 years)
3

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.

Time frame
After treatment plus follow up for 2 years (up to 4 years)
4

Overall Survival (OS)

Overall survival is defined by the date of randomization to date of death from any cause.

Time frame
After treatment plus follow up for 2 years (up to 4 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Delcath Systems Inc.

Collaborator

Source ClinicalTrials.gov
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