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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Immunotherapy
Secondary outcome measures
Assess Objective Response Rate
Evaluate the effect(s) combination FMT and immunotherapy has on changes in immune blood biomarkers
Evaluate the effect(s) combination FMT and immunotherapy has on patient's metabolomics
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Study InterventionExperimental Treatment1 Intervention
Fecal Microbial Transplantation - all patients registered on study will receive one dose (80-100mg) of FMT. This is a single arm, unblinded study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbial Transplantation
2017
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,408 Total Patients Enrolled
John Lenehan, MDPrincipal InvestigatorLondon Regional Cancer Program
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma cannot be removed by surgery and may have any BRAF status.I cannot receive FMT due to specific health reasons.You have a disease that can be measured according to specific guidelines.I have an immune system condition or am taking high-dose steroids or other drugs that weaken my immune system.I cannot have a colonoscopy due to physical reasons.My cancer has spread to my brain or spinal cord.I have inflammatory bowel disease.I am taking a low dose of steroids, not more than 10 mg of prednisone daily or its equivalent.I am 18 years old or older.You have severe allergies to certain foods like shellfish, nuts, or seafood.I have not had a live vaccine in the last 4 weeks.I had cancer before, but I've been free of it for 5 years after treatment.I will not need any other cancer treatment during the study.I am currently using antibiotics or have used them in the last two weeks.I have used high dose steroids in the last 3 months.I have a long-term gut condition like Celiac or a tumor in my colon.I am currently being treated for an infection.I am able to care for myself and perform daily activities.I do not have serious illnesses like uncontrolled heart disease, severe lung problems, or autoimmune diseases.I have had lung inflammation treated with steroids or have it now.I understand the long-term safety of FMT is not fully known.I have been diagnosed with toxic megacolon.I have an autoimmune disease that needs steroids or other immune-suppressing drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Study Intervention
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.
Is Fecal Microbial Transplantation sanctioned by the FDA?
"Fecal Microbial Transplantation was evaluated as 1 on a scale of 1 to 3 due to its Phase 1 status, indicating that there is modest evidence surrounding safety and efficacy."
Answered by AI
Are there any opportunities to join this research initiative presently?
"As per information on clinicaltrials.gov, this investigation is not currently enrolling patients despite being initially posted on March 27th 2019 and updated as recently as December 14th 2021. However, 753 other studies are presently recruiting participants."
Answered by AI
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