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FMT + Immunotherapy for Non-Small Cell Lung Cancer or FMT + Immunotherapy for Melanoma (FMT-LUMINATE Trial)
Phase 2
Waitlist Available
Led By Bertrand Routy, MD, PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage IV or unresectable disease
No prior anti-PD1 treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
FMT-LUMINATE Trial Summary
This trial will test whether combining fecal matter transplants with immunotherapy can help fight tumors.
Who is the study for?
Adults over 18 with certain types of advanced melanoma or non-small cell lung cancer (NSCLC) that haven't been treated with anti-PD1 drugs. They must understand the risks of fecal microbial transplantation (FMT), not have autoimmune diseases, active infections, severe heart conditions, or be pregnant. Participants should not be on high-dose steroids and must agree to effective contraception.Check my eligibility
What is being tested?
The trial is testing the combination of FMT and immune checkpoint inhibitors (ICI) as a treatment for advanced melanoma and NSCLC. It aims to see if adding FMT can boost the anti-tumor effects of ICI therapy in patients who meet specific health criteria.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's activation such as inflammation in various organs, digestive issues due to FMT, increased risk of infection from both treatments, and possible infusion-related reactions from ICI therapy.
FMT-LUMINATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is at stage IV or cannot be surgically removed.
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I have never received anti-PD1 treatment.
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My cancer is melanoma or NSCLC and cannot be removed by surgery.
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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I am not pregnant.
FMT-LUMINATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 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 in the NSCLC cohort by RECIST criteria.
Secondary outcome measures
Incidence of treatment-related adverse events (Safety and tolerability)
Incidence of treatment-related laboratory test abdnomarlities (Safety and tolerability)
Overall survival at 1 year in the NSCLC cohort assessed by RECIST criteria.
+1 moreFMT-LUMINATE Trial Design
1Treatment groups
Experimental Treatment
Group I: Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).Experimental Treatment1 Intervention
Metastatic or advanced NSCLC: Single-agent Pembrolizumab (2 mg/kg or 200 mg every 3 weeks) in combination with investigational FMT capsules as follows: Full FMT at least 7 days prior to first cycle of Pembrolizumab.
Metastatic melanoma and uveal melanoma: Combination therapy of Ipilimumab plus Nivolumab (Ipilimumab 3 mg/kg every 3 weeks and Nivolumab 1 mg/kg every 3 weeks x 4 doses, followed by Nivolumab 3 mg/kg or 240mg every 2 weeks or 6 mg/kg or 480mg every 4 weeks) in combination with investigational FMT capsules as follows: full FMT at least 7 days prior to first treatment with Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the second cycle with combination Ipilimumab plus Nivolumab, followed by supportive FMT within 7 days of the third cycle of Ipilimumab plus Nivolumab.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,592 Total Patients Enrolled
2 Trials studying Melanoma
71 Patients Enrolled for Melanoma
Bertrand Routy, MD, PhDPrincipal InvestigatorCHUM
1 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Melanoma
45 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active inflammatory bowel condition.I have not taken antibiotics in the last 2 weeks.My condition is at stage IV or cannot be surgically removed.I have never received anti-PD1 treatment.My melanoma returned more than 6 months after my last immunotherapy.I will stop taking probiotics 24 hours before FMT and won't take them during immunotherapy.I had cancer before, but I've been free of it for two years after treatment.I have brain metastases or leptomeningeal disease that hasn't been treated.I have an immune system condition or have been on strong immune system medications.I have an autoimmune disease that needs steroids or immunosuppressants.I do not have serious heart problems, infections, or inflammatory bowel disorders.I have a long-term serious gut condition.I have been diagnosed with toxic megacolon.I understand the risks of receiving a fecal microbiota transplant.My cancer is melanoma or NSCLC and cannot be removed by surgery.I am able to get out of my bed or chair and move around.I have had pneumonitis treated with steroids or have it now.If you have vitiligo, type I diabetes, or had asthma or allergies as a child, you can still participate.I have taken high dose steroids by mouth or IV in the last 3 months.I am currently being treated for an infection.I won't need other cancer treatments during the study.I cannot receive FMT due to specific health reasons.I use bronchodilators or get local steroid shots occasionally.You have severe allergies to foods like shellfish, nuts, or seafood.I do not have HIV, AIDS, active hepatitis B, or hepatitis C.I have not received a live vaccine in the last 4 weeks.I have only received the flu shot, not the nasal spray vaccine.I am 18 years old or older.For patients with non-small cell lung cancer, the level of PD-L1 expression in the tumor is at least 50%.Your disease can be measured and evaluated using a specific method called iRECIST.I am using or willing to use effective birth control during and for 60 days after the study.I am taking a low dose of steroids, not more than 10 mg of prednisone daily or its equivalent.I am not pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Immune checkpoint inhibitor (ICI) therapy in combination with fecal microbial transplantation (FMT).
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being admitted to this research program?
"Affirmative, the details hosted on clinicaltrials.gov show that this medical study is still seeking participants. Initially posted on November 16th 2021 and most recently updated August 19th 2022, it requires 70 enrollees between 4 different locations."
Answered by AI
To what extent is FMT in combination with ICI a secure treatment for patients?
"Our team at Power has assigned FMT + ICI a score of 2 due to this being in the Phase 2 stage; while there is some evidence suggesting safety, no such data exists for efficacy."
Answered by AI
Are there any remaining openings for participants in this experiment?
"According to clinicaltrials.gov, this trial is actively seeking participants and has been updated with new information as recently as August 19th 2022. Its first posting was on November 16th 2021."
Answered by AI
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