Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This phase Ib trial tests the safety, side effects, and best dose of STI-3031 given directly into the into the lymph nodes or the lymph vessels (intra-lymphatic) using the Sofusa DoseConnect device in treating patients with melanoma that has spread through a lymph vessel and begins to grow more than 2 centimeters away from the primary tumor but before it reaches the nearest lymph node (in-transit). Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Eligible Conditions
- Melanoma
- Recurrent Metastatic Melanoma
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Metastatic Melanoma
Treatment Effectiveness
Effectiveness Progress
Other trials for Melanoma
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: Up to 2 years
Baseline and prior to cycle 3
Lymphatic flow rate
Year 2
Progression-free survival (PFS)
Up to 2 years
Incidence of adverse events
Indocyanine green (ICG) lymphography classification
Response rate
Day 42
Maximum tolerated dose (MTD) of STI-3031 that can be administered through the DoseConnect device
Day 126
Clinical benefit rate
Trial Safety
Safety Progress
Other trials for Melanoma
Trial Design
1 Treatment Group
Treatment (STI-3031)
1 of 1
Experimental Treatment
18 Total Participants · 1 Treatment Group
Primary Treatment: Treatment (STI-3031) · No Placebo Group · Phase 1
Treatment (STI-3031)Experimental Group · 2 Interventions: Anti-PD-L1 Monoclonal Antibody IMC-001, Punch Biopsy · Intervention Types: Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Punch Biopsy
2017
N/A
~40
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
2021First Recorded Clinical Trial
19 TrialsResearching Melanoma
502 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Hemoglobin > 8.0 g/dL (obtained =< 15 days prior to registration).
You have a total bilirubin level of less than 1.5 x ULN.
You have metastatic melanoma of the lymph nodes in lymphatic beds accessible to limb-lymphatic infusion.
You have at least one tumor that is ≥ 15 mm as assessed by CT, PET or MRI (target lesion by RECIST).
You have a platelet count of at least 75,000/mm^3.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Top Oncology Trials
Top Clinical Trials in Cities
Relevant Clinical Trials
Unbiased Results
We believe in providing patients with all the options.Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.Back to top
Conditions
Cancer Related
Treatments