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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
Patients with CNS progression (parenchymal but not leptomeningeal) are eligible if CNS metastases are treated and deemed stable (with a repeat CT/MRI imaging study) prior to the enrollment date. If radiation is used to treat CNS parenchymal disease, a 2 week washout period will apply (counted from Day 1 treatment). Stability must be confirmed with a repeat CT/MRI imaging study performed as part of the screening evaluation (at least 2 weeks after radiation). Patients with new CNS metastases identified during screening are ineligible.
Consent to receive FMT administered endoscopically (colonoscopically) and undergo necessary bowel preparation pre-procedure.
Must not have
Has a known history of active TB (Bacillus Tuberculosis).
Has a history of (non-infectious) pneumonitis that was life-threatening and/or required invasive support (CTCAE grade 4 or greater) or current pneumonitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
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 belowSelect...
My brain metastases are stable and treated, with no new growths found during screening.
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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 am fully active or restricted in physically strenuous activity but can do light work.
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I have advanced melanoma that cannot be removed by surgery, but it's not in my eyes or mucous membranes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active tuberculosis infection.
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I have had severe lung inflammation that was life-threatening or needed intensive care.
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I currently have COVID-19 or have been exposed to it recently.
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I do not have serious illnesses like heart disease, bleeding disorders, severe lung problems, active infections, or inflammatory bowel diseases.
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I am HIV positive.
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My cancer is stable or improving on PD-1 therapy.
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I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
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 moreOther outcome measures
Association of PD-1 response with (common) gut microbiota
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).
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Who is running the clinical trial?
Zarour, Hassane, MDLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,245 Total Patients Enrolled
120 Trials studying Melanoma
21,984 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I won't need any other cancer treatments during the study.My organs are functioning well.I agree to use birth control or practice abstinence during and up to 120 days after the study.I am a man who can father children and will use birth control during and after the study.My symptoms are stable and not rapidly worsening.You understand that there is a small chance of getting infections from the stool used in the treatment, even though it has been checked for germs. After the treatment, there is a small chance of getting very sick from certain bacteria and infections.You had a serious allergic reaction to pembrolizumab or any of its ingredients.I have an active tuberculosis infection.I still have side effects from previous treatments that are not mild.If you are a woman who can have children, you need to have a negative pregnancy test within 72 hours before starting the study. If the urine test is positive or unclear, a blood test will be needed.I agree to participate in additional studies and have tumor tissue available for biopsy.I have had severe lung inflammation that was life-threatening or needed intensive care.I have an immune system disorder or am on high-dose steroids or other drugs that weaken my immune system.My brain metastases are stable and treated, with no new growths found during screening.I have not received a live vaccine in the last 4 weeks.I am HIV positive.I do not have active Hepatitis B or C, or I am disease-free after treatment.My cancer can be measured and biopsied according to specific guidelines.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I currently have COVID-19 or have been exposed to it recently.I do not have serious illnesses like heart disease, bleeding disorders, severe lung problems, active infections, or inflammatory bowel diseases.I agree to have a fecal transplant via a colonoscopy and prepare my bowel for it.I have stable brain metastases, not on high-dose steroids, and no leptomeningeal disease.I have an autoimmune disease but it's controlled and doesn't require strong medication.I had cancer before, but it's been cured and hasn't shown signs for 5 years, except for certain skin, bladder, cervical, breast cancers or melanomas which were treated successfully.I understand the risks of receiving a stool transplant, including allergies and other health issues.I have had treatments, including vaccines and radiation, for my cancer after it spread.My cancer did not respond to at least 2 doses of a specific immunotherapy.My cancer is stable or improving on PD-1 therapy.I do not have severe allergies, toxic megacolon, inflammatory bowel disease, or issues preventing a colonoscopy.I am currently being treated for an infection.You need to know that we don't have enough information about the long-term safety of FMT (fecal microbiota transplantation).I have advanced melanoma that cannot be removed by surgery, but it's not in my eyes or mucous membranes.I am currently on pembrolizumab or nivolumab for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplant (FMT) with Pembrolizumab
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.
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