Treatment (STI-3031) for Melanoma

Phase-Based Progress Estimates
Mayo Clinic in Rochester, Rochester, MN
Melanoma+3 More
Anti-PD-L1 Monoclonal Antibody IMC-001 - Biological
All Sexes
What conditions do you have?

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

1 of 3

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

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
First Studied
Drug Approval Stage
How many patients have taken this drug
Punch Biopsy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.