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Microbiota Therapy

FMT + Pembrolizumab for Melanoma

Phase 2
Waitlist Available
Led By Diwakar Davar, MD
Research Sponsored by Zarour, Hassane, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma. Patient may not have a diagnosis of uveal or mucosal melanoma.
Have received any number of prior systemic therapies for metastatic disease. Prior radiation therapy (any number) and interferon use (any formulation and/or duration) in the adjuvant or metastatic disease settings is permitted. Vaccine therapy will be counted as systemic therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing if FMT can help the body fight cancer.

Who is the study for?
Adults with advanced melanoma not responding to PD-1 immunotherapy can join this trial. They must be receiving pembrolizumab or nivolumab, have stable brain metastases if present, and agree to a fecal transplant via colonoscopy. Pregnant women, those with severe allergies or autoimmune diseases, and patients with certain serious health conditions are excluded.Check my eligibility
What is being tested?
The study is testing whether adding a fecal microbiota transplant (FMT) to the existing PD-1 immunotherapy (pembrolizumab/nivolumab) helps improve the body's cancer-fighting abilities in melanoma patients who haven't responded well to treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to FMT such as infection risk from donor stool, allergic reactions, and possible long-term risks like obesity or autoimmune disorders. Colonoscopy risks include perforation and pneumonia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced melanoma that cannot be removed by surgery, but it's not in my eyes or mucous membranes.
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I have had treatments, including vaccines and radiation, for my cancer after it spread.
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I am currently on pembrolizumab or nivolumab for my cancer.
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My cancer did not respond to at least 2 doses of a specific immunotherapy.
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My brain metastases are stable and treated, with no new growths found during screening.
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I understand the risks of receiving a stool transplant, including allergies and other health issues.
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My cancer can be measured and biopsied according to specific guidelines.
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I am a man who can father children and will use birth control during and after the study.
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I agree to participate in additional studies and have tumor tissue available for biopsy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organs are functioning well.
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I agree to have a fecal transplant via a colonoscopy and prepare my bowel for it.
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I am 18 years old or older.
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I agree to use birth control or practice abstinence during and up to 120 days after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Change in Innate/adaptive immune system subsets
Body Weight Changes
Function of T-cells
+3 more
Other outcome measures
Association of PD-1 response with (common) gut microbiota

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota Transplant (FMT) with PembrolizumabExperimental Treatment1 Intervention
The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes. Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4).

Find a Location

Who is running the clinical trial?

Zarour, Hassane, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,847 Previous Clinical Trials
5,045,904 Total Patients Enrolled
119 Trials studying Melanoma
21,462 Patients Enrolled for Melanoma
Diwakar Davar, MD5.01 ReviewsPrincipal Investigator - Univ of Pittsburgh
University of Pittsburgh
7 Previous Clinical Trials
245 Total Patients Enrolled
6 Trials studying Melanoma
219 Patients Enrolled for Melanoma
5Patient Review
Dr. Davar is very patient and caring, which is reassuring given my recent cancer diagnosis. He always takes the time to explain things to me so that I can understand them.

Media Library

Fecal Microbiota Transplant (Microbiota Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03341143 — Phase 2
Melanoma Research Study Groups: Fecal Microbiota Transplant (FMT) with Pembrolizumab
Melanoma Clinical Trial 2023: Fecal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT03341143 — Phase 2
Fecal Microbiota Transplant (Microbiota Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03341143 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots in this trial that remain open for new participants?

"The clinical trial in question is not currently seeking patients, as evidenced by the fact that it was last updated over two years ago. That said, there are nearly 1800 other trials actively recruiting patients right now."

Answered by AI

What are some of the main conditions that Fecal Microbiota Transplant with Pembrolizumab has been shown to improve?

"Fecal Microbiota Transplant with Pembrolizumab is a treatment for cancer that can also help patients manage microsatellite instability high and disease progression after chemotherapy."

Answered by AI

Could you please remind me of the dangers associated with Fecal Microbiota Transplant with Pembrolizumab?

"Although there is no data supporting Fecal Microbiota Transplant with Pembrolizumab's efficacy, there is enough evidence to rate its safety as a 2."

Answered by AI

What does the research say about using Fecal Microbiota Transplantation in combination with Pembrolizumab?

"There are currently 1000 studies underway researching the potential of fecal microbiota transplantation (FMT) with pembrolizumab for cancer treatment. 122 of those trials are in Phase 3, and 36034 locations around the world are participating. Many of the studies for FMT with pembrolizumab are based in Houston, Texas."

Answered by AI
~3 spots leftby Feb 2025