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Fecal Microbial Transplant for Melanoma

Phase 1

Waitlist Available

Led By John Lenehan, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, prior to 1st dose of immunotherapy (1 week post fmt) and 2nd dose of immunotherapy(2, 3, or 4 weeks post fmt depending on type of immunotherapy received), and at the 3 month follow-up visit

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the safety of combining an immunotherapy drug with fecal microbial transplantation (FMT) in treating patients with stage III-IV melanoma that has spread to other parts of the body.

Who is the study for?

This trial is for adults with advanced melanoma that can't be surgically removed. Participants must have an ECOG performance status of 0-2, indicating they are fully active or limited in physical activity but able to care for themselves. They should understand the risks of FMT and be capable of swallowing capsules. Pregnant individuals, those on high-dose steroids or immunosuppressants, recent antibiotic users, and patients with certain other health conditions cannot join.

What is being tested?

The MIMic trial tests whether combining Fecal Microbial Transplantation (FMT) from a healthy donor with standard immunotherapy drugs like pembrolizumab or nivolumab improves treatment response in melanoma patients. The study will assess safety and effects on the immune system and gut microbes.

What are the potential side effects?

Potential side effects include reactions related to the body's immune response due to immunotherapy drugs such as fatigue, skin issues, inflammation-related symptoms across various organs, as well as risks associated with ingesting fecal material from donors which may include gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, prior to 1st dose of immunotherapy (1 week post fmt) and 2nd dose of immunotherapy(2, 3, or 4 weeks post fmt depending on type of immunotherapy received), and at the 3 month follow-up visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, prior to 1st dose of immunotherapy (1 week post fmt) and 2nd dose of immunotherapy(2, 3, or 4 weeks post fmt depending on type of immunotherapy received), and at the 3 month follow-up visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, prior to 1st dose of immunotherapy (1 week post fmt) and 2nd dose of immunotherapy(2, 3, or 4 weeks post fmt depending on type of immunotherapy received), and at the 3 month follow-up visit for reporting.