Hepzato Kit + Opdualag for Skin Cancer with Liver Metastases

Overseen By Cancer Connect

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Prednisone

Disqualifiers: Brain metastases, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to determine if they work better together for skin cancer that has spread to the liver. Researchers aim to discover whether using Hepzato Kit with two drugs, nivolumab and relatlimab, can improve outcomes for people with this type of cancer. The trial seeks participants diagnosed with metastatic melanoma (a type of skin cancer) that has spread to the liver and who have not yet received systemic treatment for this advanced stage. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you are taking prednisone at a dose of 10 mg per day or more. It's best to discuss your current medications with the trial team to be sure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using nivolumab and relatlimab together to treat advanced melanoma is generally safe. Studies have found that this combination can help patients without causing more side effects than nivolumab alone. For example, patients lived longer without their cancer worsening.

In earlier trials, patients tolerated the combination well, experiencing side effects similar to those from other advanced melanoma treatments. These side effects were manageable and did not outweigh the treatment's benefits. Overall, the safety data suggests this combination is a promising option for people with advanced melanoma, even for those whose cancer has spread to the liver. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Nivolumab and Relatlimab for skin cancer with liver metastases because these treatments introduce a unique combination approach. Nivolumab is a PD-1 inhibitor, which helps the immune system detect and attack cancer cells. Relatlimab, on the other hand, targets LAG-3, another checkpoint that can slow down the immune response to cancer. This dual mechanism aims to unleash the immune system more effectively than current treatments like single-agent checkpoint inhibitors or chemotherapy, potentially offering a more robust attack against metastatic melanoma.

What evidence suggests that this treatment might be an effective treatment for skin cancer with liver metastases?

Research has shown that using nivolumab and relatlimab together, both of which help the immune system fight cancer, appears promising for treating advanced melanoma, even when it has spread to the liver. This trial will evaluate the effectiveness of this combination for participants with metastatic melanoma. Studies have found that this combination can delay cancer progression for a longer period. Compared to other treatments, it might work better and have fewer side effects. Relatlimab appears to work as well as another treatment called ipilimumab, but with potentially fewer side effects. Early results suggest this combination could be a good first choice for treating melanoma in patients whose cancer has spread to the liver. ^{2 3 5 6 7}

Who Is on the Research Team?

Vincent Ma, MD

Principal Investigator

UW Carbone Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with metastatic melanoma that has spread to the liver, who haven't had treatment for their advanced cancer yet. They need a positive liver biopsy for melanoma, weigh at least 35 kg, and have good organ function. People can't join if they've had severe immune-related side effects from similar drugs before, received an organ transplant, or used certain treatments like HEPZATO KIT™.

Inclusion Criteria

Evaluable/measurable disease according to RECIST v1.1

My organ functions are within normal ranges as per recent tests.

Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System)

Exclusion Criteria

I had a severe reaction to previous immunotherapy but was able to continue treatment without serious side effects.

I have received an organ transplant.

I have been treated with HEPZATO KIT™ or Opdualag™ before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™) for metastatic melanoma with liver metastasis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Nivolumab
• Relatlimab

Trial Overview

The study tests whether combining Hepzato Kit (Melphalan) with Opdualag (Nivolumab and Relatlimab) is safe and works better than previous therapies for patients with skin cancer that's moved to the liver. It's a first-line treatment comparison against historical data of similar conditions.

How Is the Trial Designed?

Group I: Participants with Metastatic Melanoma Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Delcath Systems Inc.

Industry Sponsor

Trials

11

Recruited

970+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07281924

Hepzato Kit and Opdualag for Metastatic Melanoma and ...

To evaluate the tumor reduction at any time during treatment in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10164023/

The Latest Option: Nivolumab and Relatlimab in Advanced ...

Dual immune checkpoint inhibition with ipilimumab plus nivolumab is currently the most effective, but also by far the most toxic treatment for advanced melanoma ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.24.01125

First-Line Nivolumab Plus Relatlimab Versus ...

... treatment for melanoma brain metastases ... Relatlimab and nivolumab versus nivolumab in previously untreated metastatic or unresectable melanoma ...

4.

oncologynewscentral.com

oncologynewscentral.com/melanoma/nivolumab-plus-relatlimab-shows-sustained-pfs-benefit-in-advanced-melanoma

Nivolumab Plus Relatlimab Shows Sustained PFS Benefit ...

nivolumab plus ipilimumab, it is still unclear which combination is superior in the first line metastatic setting,” Dr. Muddasani said. “More ...

5.

cancernetwork.com

cancernetwork.com/view/relatlimab-shows-comparable-efficacy-to-ipilimumab-in-advanced-melanoma

Relatlimab Shows Comparable Efficacy to Ipilimumab in ...

After weighting, the any-grade treatment-related adverse effect (TRAE) incidence in the relatlimab and ipilimumab arms were 85% vs 96%.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0014299925007459

Safety profile of nivolumab-relatlimab in cancer patients

Clinical trials have demonstrated that relatlimab plus nivolumab improved progression free survival compared with nivolumab alone for patients with advanced ...

7.

mdanderson.org

mdanderson.org/newsroom/neoadjuvant-immunotherapy-with-relatlimab-and-nivolumab-is-safe-and-effective-in-stage-3-melanoma.h00-159543690.html

Neoadjuvant immunotherapy with relatlimab and ...

Our findings support the combination of relatlimab and nivolumab as a safe and effective treatment option in the neoadjuvant setting for stage III melanoma.