Active not recruitingPHASE1INTERVENTIONAL

Fecal Microbial Transplantation in Combination With Immunotherapy in Melanoma Patients (MIMic)

This study, called MIMic, is exploring a new way to treat advanced melanoma by combining Fecal Microbial Transplantation (FMT) with standard immunotherapy drugs like pembrolizumab or nivolumab. Immunotherapy helps your body's immune system fight cancer, but it doesn't work for everyone. Recent research suggests that the good bacteria in your gut (your microbiome) might affect how well these drugs work. FMT involves transplanting healthy gut bacteria from a donor to a patient. This study wants to find out if combining FMT with immunotherapy is safe for melanoma patients. Researchers will also look at how FMT changes the patient's immune system and gut bacteria, hoping to improve treatment responses. It's a Phase 1 study, meaning the main goal is to check for safety.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

27 Mar 2019

Estimated completion

01 Aug 2026

Melanoma

What is this study about?

In recent years, immunotherapy has brought a lot of hope to cancer patients. These clever drugs, like pembrolizumab and nivolumab, work by giving your body's own immune system a boost to find and fight cancer cells. Think of it like taking the brakes off your internal cancer-fighting team. For some people with advanced melanoma, these treatments have been very effective.

However, immunotherapy doesn't work for everyone, and scientists are trying to understand why. Emerging evidence suggests that the tiny organisms living in your gut, collectively known as your gut microbiome, might play a surprisingly big role. It seems that patients who respond well to immunotherapy often have a specific mix of healthy bacteria in their gut. This has led researchers to wonder: if we can make a patient's gut bacteria healthier and more diverse, could it improve how they respond to immunotherapy?

This is where Fecal Microbial Transplantation (FMT) comes in. FMT is a procedure where healthy stool from a carefully screened donor is transferred to a patient. It's already successfully used to treat certain serious gut infections in people without cancer. In this study, called MIMic, researchers are combining FMT with the standard immunotherapy drugs used for advanced melanoma. The main goal of this study is to find out if this combination treatment is safe. They will also look at how FMT might change the patient's immune system and their gut bacteria, hoping to understand if this approach could help more people benefit from immunotherapy.

Key takeaways

This study combines a gut bacteria treatment (FMT) with standard immunotherapy for advanced melanoma.
The main goal is to find out if this combination treatment is safe.
Researchers are also exploring if FMT can make immunotherapy more effective by improving gut health.
It's a 'Phase 1' study, meaning safety is the top priority.
Understanding the role of gut bacteria in cancer treatment is a growing area of research.

Who may be eligible?

To take part in this study, you would generally need to be 18 years old or older and have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread. Your overall health and ability to go about daily activities should be quite good, and you must be able to understand what the study involves and agree to take part in writing.

There are certain situations that would prevent someone from joining. For example, if you are pregnant or breastfeeding, or planning to have children soon, you cannot participate. You also cannot be taking high doses of steroids or certain other medications that affect your immune system. If you have been on antibiotics recently or have certain long-term gut conditions like Inflammatory Bowel Disease, or severe allergies to foods like shellfish or nuts, you would also not be able to join this study. The medical team will check all your health details carefully to make sure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have advanced melanoma that can't be surgically removed or has spread?
Are you able to swallow capsules without issue?
Have you avoided antibiotics in the last two weeks before the planned FMT, or do you expect to avoid them?
Are you not pregnant, breastfeeding, or planning to conceive or father children during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive FMT combined with either pembrolizumab or nivolumab, which are standard immunotherapy drugs for advanced melanoma. The FMT involves receiving specially prepared stool material from a healthy donor. The researchers will closely monitor your health to check for any side effects from the combination treatment. This involves regular check-ups, blood tests, and possibly scans to see how your body is reacting and how the treatment is affecting your immune system and gut bacteria. You will need to be able to take capsules for the FMT. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and helping advance medical knowledge for others. However, there are also potential risks, as FMT is being combined with immunotherapy for the first time in melanoma patients, and its long-term safety is not fully known. You might experience side effects from either treatment, or from the combination. All possible risks will be fully explained to you by the study team. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

London Regional Cancer Program
Verified postcode
London, Canada
CHUM
Approximate
Montréal, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada

Common questions

What is Fecal Microbial Transplantation (FMT)?

FMT involves transferring healthy gut bacteria from a carefully screened donor to a patient to improve their gut health.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that boosts your body's own immune system to fight cancer cells.

Why are they combining FMT with immunotherapy?

Researchers want to see if FMT can make immunotherapy work better by improving the balance of bacteria in the gut.

Is this a new treatment for melanoma?

Immunotherapy is standard for melanoma, but combining it with FMT for melanoma is new and being studied for safety.

What is a 'Phase 1' study?

A Phase 1 study primarily focuses on checking if a new treatment or combination of treatments is safe for patients.