Immunotherapy for Melanoma

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals, Immunosuppressants

Disqualifiers: Pregnancy, CNS metastases, HIV, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 378 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new immunotherapy treatment called STI-3031 for individuals with a specific type of melanoma that has spread in a particular way. The main goals are to assess the treatment's safety, understand its side effects, and determine the optimal dose. The study seeks participants with melanoma that has spread to the lymph system but remains confined to one limb. If melanoma has spread in a limb but hasn't reached major organs, this trial might be suitable. The treatment involves an intra-lymphatic injection using the Sofusa DoseConnect Device. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on systemic steroids or immunosuppressive drugs for active autoimmune disease, you may need to stop or adjust those medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Sofusa DoseConnect device and STI-3031 are safe for treating melanoma?

Research shows that STI-3031, a new treatment that helps the immune system fight cancer, is being tested for safety in patients with melanoma, a specific type of skin cancer. Previous studies indicate that patients have generally tolerated similar treatments well. However, since this is an early-stage trial, the main goal is to determine the best dose and closely monitor for any side effects. Researchers are still collecting safety information, and participants will be carefully observed for any negative reactions. If STI-3031 resembles other treatments of its kind, common side effects might include fatigue, skin reactions, or flu-like symptoms. Overall, the trial aims to find the safest way to use this new treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for melanoma, which often involve surgery, radiation, or systemic therapies like chemotherapy and immune checkpoint inhibitors, STI-3031 offers a unique approach. This treatment is administered directly into the lymphatic system using the Sofusa DoseConnect device, which allows for more targeted delivery. Researchers are excited about this because it could enhance the immune response specifically against melanoma cells, potentially improving effectiveness while minimizing side effects. Additionally, this method of delivery might allow the drug to work more efficiently, providing a new avenue for tackling melanoma that differs from traditional systemic routes.

What evidence suggests that the intra-lymphatic injection using the Sofusa DoseConnect device might be an effective treatment for melanoma?

Research has shown that STI-3031, an immunotherapy treatment, might help the body's immune system fight melanoma, a type of skin cancer. Immunotherapy uses the body's natural defenses to combat cancer. In this trial, participants will receive STI-3031 intra-lymphatically using the DoseConnect device. Early studies suggest that delivering STI-3031 directly into the lymph nodes or vessels can target melanoma more effectively and reduce side effects. This method aims to stop cancer cells from growing and spreading. Although detailed information from human studies remains limited, this approach shows promise for improving melanoma treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Anastasios Dimou, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Adults with in-transit melanoma confined to a limb, or metastatic melanoma of the lymph nodes accessible for treatment. Participants must have adequate organ function and agree to use contraception. Excluded are pregnant or nursing individuals, those planning pregnancy soon, patients with ITM beyond reachable areas by DoseConnect, severe allergies to monoclonal antibodies or related substances, uncontrolled diseases, and certain prior treatments.

Inclusion Criteria

I have a visible or non-visible tumor or lymph node that is at least 1.0 cm big.

I am willing to give tissue samples for research.

Rochester only: Willingness to provide mandatory blood specimens for correlative research

Exclusion Criteria

You have had serious allergic reactions to other drugs like the one being tested in the study, or to certain dyes and substances.

I am not on any experimental drugs for my cancer.

My melanoma has spread and I haven't received treatment for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours once weekly for 6 weeks in cycle 1 and once every 2 weeks for 6 weeks in cycle 2. Treatment may continue for up to 9 cycles based on response.

Up to 378 days

Weekly visits for cycle 1, bi-weekly visits for cycle 2

Follow-up

Participants are monitored for safety and effectiveness after treatment completion at 2-4 weeks, 90 days, and every 3 months for up to 2 years.

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Intra-Lymphatic Injection using Sofusa DoseConnect Device
• STI-3031

Trial Overview The trial is testing STI-3031—an anti-PD-L1 monoclonal antibody—administered directly into lymphatics using Sofusa DoseConnect. It aims to find the safest dose while observing how well it helps the immune system fight cancer spread through lymph vessels from an original tumor site.

How Is the Trial Designed?

Group I: Treatment (STI-3031) Experimental Treatment 2 Interventions

Patients receive STI-3031 intra-lymphatically via the DoseConnect device over 1-8 hours QW on days 1, 8, 15, 22, 29, and 36 of cycle 1, and Q2W on days 1, 15, and 29 of cycle 2. Treatment repeats every 42 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR at the end of cycle 2 receive 1-2 additional cycles in the absence of disease progression or unacceptable toxicity. Patients with PR or SD at the end of cycle 2 continue treatment for a total of 9 cycles in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A retrospective analysis of 21 patients with advanced cutaneous melanoma showed that nonselected autologous tumor-infiltrating lymphocytes (TILs) resulted in a high overall response rate of 67% and a complete response rate of 19%, indicating significant efficacy even in patients who had previously undergone PD-1 inhibition.

The treatment was found to be safe, with no treatment-related deaths and a median overall survival of 21.3 months, suggesting that TIL therapy could be a promising option for patients with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical feasibility and treatment outcomes with nonselected autologous tumor-infiltrating lymphocyte therapy in patients with advanced cutaneous melanoma. Pillai, M., Jiang, Y., Lorigan, PC., et al.[2022]

In a study of 10 patients with advanced melanoma treated with autologous tumor-infiltrating lymphocytes (TILs) and interleukin-2 (IL-2), no serious adverse effects were reported, indicating a favorable safety profile for this immunotherapy approach.

Among the patients, there were instances of complete and partial remission, with one patient surviving for 9 years post-treatment, suggesting potential long-term benefits; however, the presence of certain T cell types was associated with shorter overall survival, highlighting the need for further research into optimizing treatment combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes in Advanced Melanoma Patients. Saint-Jean, M., Knol, AC., Volteau, C., et al.[2021]

Intratumoral therapy for advanced melanoma allows for direct delivery of medications into tumors, potentially increasing local drug concentration and attracting immune cells, which may lead to fewer systemic side effects.

This review highlights that intratumoral therapies can act as in situ vaccines, offering the possibility of controlling disease both locally within the tumor and systemically throughout the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intratumoral therapies and in-situ vaccination for melanoma. Huppert, LA., Daud, AI.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-melanoma-6-2022-94fb0

Immunotherapy for Melanoma · Info for Participants This trial uses STI-3031, delivered directly into lymph nodes or vessels with a special device, to treat patients with a specific type of melanoma that has ...

2. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/metastatic-melanoma

Metastatic Melanoma Clinical Trials This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12308841/

Barriers to the successful treatment of melanoma - PMC Large-scale clinical trials incorporating novel targeted therapy combinations have been unsuccessful in significantly improving outcomes ...

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/melanoma

Melanoma Clinical Trials The purpose of this phase trial is to identify the best dose of STI-3031 that can be administered through the DoseConnect device in treating patients with ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0378517324011116

Novel strategies in systemic and local administration of ... Here, we confirm the authors' opinion that this approach is likely to lead to reduction in systemic adverse effects, improved clinical outcomes ...

6. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/skin-cancer

Skin Cancer Clinical Trials The purpose of this phase trial is to identify the best dose of STI-3031 that can be administered through the DoseConnect device in treating patients with ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0020306

Melanoma (DBCOND0020306) | DrugBank Online NCT01673854. Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma. Ipilimumab · Vemurafenib.