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Immunotherapy for Melanoma
Phase 1
Waitlist Available
Led By Anastasios Dimou, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new immunotherapy to see if it's safe and effective in treating melanoma that has spread through a lymph vessel.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum tolerated dose (MTD) of STI-3031 that can be administered through the DoseConnect device
Secondary outcome measures
Clinical benefit rate
Progression-free survival (PFS)
Response rate
Other outcome measures
Indocyanine green (ICG) lymphography classification
Lymphatic flow rate
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,080 Total Patients Enrolled
40 Trials studying Melanoma
2,520 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,664 Total Patients Enrolled
557 Trials studying Melanoma
193,230 Patients Enrolled for Melanoma
Anastasios Dimou, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Melanoma
6 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a visible or non-visible tumor or lymph node that is at least 1.0 cm big.I am not on any experimental drugs for my cancer.My melanoma has spread and I haven't received treatment for it.My cancer affects my hands and feet and cannot be treated with DoseConnect infusion.I am willing to give tissue samples for research.I am 18 years old or older.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had radiation on tumors that are now being measured.I am immunocompromised or HIV positive and on antiretroviral therapy.My blood clotting tests are normal or within the target range if I'm on blood thinners.I can visit the study site for follow-ups every 3 months.I still have side effects from previous treatments.Your liver enzymes (ALT and AST) are not more than 3 times the normal level.Women who could become pregnant need to have a negative pregnancy test within 7 days before joining the study.Your blood creatinine level is not more than two times the upper limit of normal.I have undergone a major surgery recently.My melanoma has spread beyond reachable lymph nodes and cannot be treated with DoseConnect.I have received a stem cell transplant from a donor.Your total bilirubin level in the blood should be less than 1.5 times the upper limit of normal.My melanoma is in one limb, possibly affecting nearby lymph nodes.My kidneys are functioning well enough, based on a specific test.I do not have any serious ongoing illnesses that would interfere with the study.Your platelet count is at least 75,000 per cubic millimeter.My tumor is not on my arms or legs.Your hemoglobin level is 8.0 grams per deciliter or higher.My melanoma has spread to lymph nodes and can be treated with limb infusion.I have had a solid organ transplant.I am on replacement therapy like insulin or thyroxine, not for cancer treatment.You have a sufficient number of a type of white blood cell called neutrophils in your blood.I had a severe reaction to previous immune therapy or haven't fully recovered from it.I have a lymph node tumor larger than 15 mm.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (STI-3031)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts actively underway for this experiment?
"It is accurate to say that the information on clinicaltrials.gov shows this trial is actively seeking enrollees. It was initially posted in mid-June of 2022 and has been modified since then, with 18 individuals needed across a single site."
Answered by AI
How many participants have chosen to join this medical experiment?
"Affirmative. Per the clinicaltrials.gov platform, this research endeavour is still recruiting participants who signed up after June 14th 2022. At the moment, a single location needs 18 patients to sign up and partake in it."
Answered by AI
What perils can be associated with the utilization of Anti-PD-L1 Monoclonal Antibody IMC-001?
"The safety of Anti-PD-L1 Monoclonal Antibody IMC-001 is estimated to be a 1 on our team's scale due its Phase 1 status, which signals there is limited clinical data validating the drug's efficacy and safety."
Answered by AI
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