LND101 for Fecal Microbiota Transplantation in Combination With Immune Checkpoint Blockade in Advanced Melanoma
This study is investigating a new way to treat advanced melanoma, a type of skin cancer. We are looking at whether combining a treatment called LND101 with the usual immunotherapy, known as Immune Checkpoint Blockade (ICB), is more effective. LND101 is a type of treatment that helps to change the bacteria in your gut, also known as your gut microbiome. Immunotherapy works by helping your body's own immune system fight the cancer. We want to find out if adding LND101 to immunotherapy can better prevent the cancer from growing or spreading compared to immunotherapy alone. This is an important step to see if we can improve treatments for people with advanced melanoma.
At a glance
What is this study about?
This study is for people who have advanced melanoma, which is a type of skin cancer that has grown or spread. Doctors are always looking for better ways to treat this condition, and this study aims to see if a particular addition to standard care might help.
The usual treatment for advanced melanoma involves medicines called immunotherapy. These medicines work by boosting your own body's defence system, called the immune system, to find and fight cancer cells. This can help slow down the cancer's growth and even make cancer cells die. However, immunotherapy doesn't work for everyone, and researchers are trying to find ways to make it more effective.
In this study, we are exploring a new approach that combines immunotherapy with another treatment called LND101. LND101 is a type of 'faecal microbiota transplant' (FMT). This means it helps to change the types of bacteria that live in your gut. Research has shown that the bacteria in our gut, known as the microbiome, can play a role in how well our immune system works and how it responds to cancer treatments. By changing these gut bacteria, doctors hope to make immunotherapy work better against melanoma.
Key takeaways
- This study combines standard immunotherapy with a gut-bacteria-changing treatment (LND101) for advanced melanoma.
- The aim is to see if LND101 can improve how well immunotherapy works.
- You must have advanced melanoma and not have had prior immunotherapy for this stage of cancer.
- Participation involves regular check-ups, scans, and providing samples.
- There's a chance the new treatment might be more effective, but also potential risks and side effects.
- You can stop participating in the study at any time.
Who may be eligible?
To be part of this study, you would need to have been diagnosed with an advanced form of melanoma, which means it has spread or cannot be removed by surgery. This also applies if the original source of your melanoma isn't known.
You cannot have had immunotherapy for your advanced melanoma before this study. However, it's okay if you had immunotherapy as an earlier, preventative treatment (called adjuvant or neo-adjuvant therapy), as long as your last dose was at least six months ago. If you've had other types of treatment for melanoma, such as targeted therapies or radiation, that's generally fine, as long as enough time has passed and any side effects have mostly cleared up.
To join, you must be at least 18 years old and generally well enough to take part in the study activities. This means you should be able to get around and do most of your daily tasks without too much difficulty. You'll also need to be able to swallow capsules and be willing to provide blood and stool (poo) samples, and if available, a stored sample of your tumour tissue.
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.
- Do I have advanced melanoma that has spread or cannot be removed by surgery?
- Have I received previous immunotherapy for advanced melanoma (not as an earlier preventative treatment)?
- Am I at least 18 years old?
- Am I generally well enough to manage my daily activities?
- Am I able to swallow capsules?
- Am I willing to provide blood and stool samples for research?
What does participation involve?
If you decide to take part in this study, you will receive either the standard immunotherapy treatment alone or immunotherapy combined with LND101. The LND101 treatment involves taking capsules by mouth. You will continue with your standard immunotherapy treatment as decided by your doctor before joining the study.
Throughout the study, you will have regular clinic visits. During these visits, the study team will monitor your health, check for any side effects, and assess how the treatment is affecting your melanoma. This will involve physical examinations, blood tests, and scans to see if the cancer has changed. You will also be asked to provide stool samples at specific times so that researchers can study your gut bacteria.
The total length of your participation will depend on how you respond to the treatment and the study's design, but there will be a follow-up period to monitor your long-term health after treatment ends.
Potential risks and benefits
Locations (14)
- BCCA - AbbotsfordVerified postcodeAbbotsford British Columbia, Canada· Recruiting
- BCCA - SurreyVerified postcodeSurrey, Canada· Recruiting
- BCCA - VancouverVerified postcodeVancouver, Canada· Recruiting
- Juravinski Cancer Centre at Hamilton Health SciencesVerified postcodeHamilton, Canada· Recruiting
- London Health Sciences Centre Research Inc.Verified postcodeLondon, Canada· Recruiting
- Stronach Regional Health Centre at SouthlakeVerified postcodeNewmarket, Canada· Recruiting
- Ottawa Hospital Research InstituteVerified postcodeOttawa, Canada· Recruiting
- Odette Cancer CentreVerified postcodeToronto, Canada· Recruiting
- University Health NetworkVerified postcodeToronto, Canada· Recruiting
- Centre Integre de Sante et de Services SociauxVerified postcodeGreenfield Park, Canada· Recruiting
- CHUM-Centre Hospitalier de l'Universite de MontrealVerified postcodeMontreal, Canada· Recruiting
- The Jewish General HospitalVerified postcodeMontreal, Canada· Recruiting
Common questions
What is advanced melanoma?
Advanced melanoma means a type of skin cancer that has grown beyond its original site or has spread to other parts of the body.
What is immunotherapy?
Immunotherapy is a type of treatment that uses your body's own immune system to fight cancer cells.
What is LND101?
LND101 is a treatment aimed at changing the balance of bacteria in your gut, which is thought to help boost your body's response to other cancer treatments.
How will I know if I'm getting LND101 or not?
Because this is a research study, participants are randomly assigned to either receive immunotherapy alone or immunotherapy with LND101. You and your doctors may not know which treatment you are receiving until the end of the study.
Will I have to pay to be part of this study?
No, the study treatments and related study procedures will be covered by the study. However, some routine medical costs might still be covered by your usual healthcare services.
How to find out more
Janet Dancey
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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