What side effects are associated with this type of intervention?

Monoclonal antibody immunotherapy treatments for melanoma, such as pembrolizumab and avelumab, commonly cause side effects including fatigue, musculoskeletal pain, decreased appetite, pruritus (itching), diarrhea, nausea, rash, pyrexia (fever), cough, dyspnea (difficulty breathing), constipation, and abdominal pain. These treatments work by stimulating the immune system to attack cancer cells, which can also lead to immune-related adverse events affecting various organs.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibody immunotherapies for the treatment of melanoma. Pembrolizumab and nivolumab, both targeting PD-1, have been approved for advanced melanoma and have demonstrated significant efficacy in clinical trials. Ipilimumab, targeting CTLA-4, is another approved monoclonal antibody used in melanoma treatment. Combinations of these drugs, such as nivolumab plus ipilimumab, have also received approval and are utilized in clinical practice to improve patient outcomes.

What other types of research exist?

Promising novel alternatives to STI-3031 for melanoma patients include: 1) Pembrolizumab (Keytruda) - a PD-1 inhibitor that has shown significant efficacy in melanoma. 2) Nivolumab (Opdivo) - another PD-1 inhibitor with proven benefits in melanoma treatment. 3) Atezolizumab - a PD-L1 inhibitor being evaluated in various cancers, including melanoma. 4) Combination therapies such as Nivolumab and Ipilimumab (Yervoy) - combining PD-1 and CTLA-4 inhibitors has shown improved outcomes in melanoma patients.

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Immunotherapy for Melanoma

Phase 1

Waitlist Available

Led By Anastasios Dimou

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with ITM, visible superficial ITM, non-nodal lesion with longest diameter >= 1.0 cm in diameter as assessed using a ruler (documentation by color photography, including a ruler is required) OR malignant regional lymph node with short axis > 1.0 cm as assessed by computed tomography (CT) scan OR non-visible, non-nodal soft tissue mass of the involved extremity with longest diameter >= 1.0 cm as measured with CT scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI)

Age >= 18 years

Must not have

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

Previously untreated metastatic melanoma (visceral or CNS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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 spread but not yet reached the nearest lymph node. The treatment works by boosting the immune system to attack cancer cells.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions at the infusion site due to Sofusa DoseConnect device usage and typical immunotherapy-related issues such as inflammation in organs (immune-related adverse events), fatigue, digestive problems like diarrhea, skin reactions and possible increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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My kidneys are functioning well enough, based on a specific test.

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My melanoma has spread to lymph nodes and can be treated with limb infusion.

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I have a lymph node tumor larger than 15 mm.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on any experimental drugs for my cancer.

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

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My cancer affects my hands and feet and cannot be treated with DoseConnect infusion.

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I have had radiation on tumors that are now being measured.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I still have side effects from previous treatments.

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I have undergone a major surgery recently.

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My melanoma has spread beyond reachable lymph nodes and cannot be treated with DoseConnect.

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I have received a stem cell transplant from a donor.

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I do not have any serious ongoing illnesses that would interfere with the study.

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My tumor is not on my arms or legs.

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I have had a solid organ transplant.

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I had a severe reaction to previous immune therapy or haven't fully recovered from it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Maximum tolerated dose (MTD) of STI-3031 that can be administered through the DoseConnect device

Secondary study objectives

Clinical benefit rate

Progression-free survival (PFS)

Response rate

Other study objectives

Indocyanine green (ICG) lymphography classification

Lymphatic flow rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (STI-3031)Experimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Punch Biopsy

2017

N/A

~40

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibody immunotherapy, such as the treatment being studied in the STI-3031 trial, works by targeting specific proteins on the surface of cancer cells or immune cells to enhance the body's immune response against the tumor. For example, drugs like pembrolizumab and nivolumab target the PD-1 receptor on T-cells, preventing cancer cells from evading immune detection. Ipilimumab targets CTLA-4, another checkpoint protein, to further stimulate immune activity. These treatments are crucial for melanoma patients as they can lead to durable responses and improved survival rates by effectively harnessing the body's own immune system to fight the cancer.