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FMT + Pembrolizumab for Melanoma
Study Summary
This trial is testing if FMT can help the body fight cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Fecal Microbiota Transplant (FMT) with Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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