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Fecal Microbiota Transplantation for Kidney Cancer (PERFORM Trial)
Phase 1
Waitlist Available
Led By Ricardo Fernandes, MD
Research Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status (KPS) ≥70%
Ability to ingest capsules
Must not have
Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to study entry
Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 years (end of study)
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying if Fecal Microbiota Transplantation (FMT) can help reduce side effects from a cancer immunotherapy drug combination.
Who is the study for?
This trial is for adults with advanced or metastatic renal cell carcinoma, specifically those at intermediate or poor risk. Participants must be in good physical condition (KPS ≥70%), able to swallow capsules, and have not had certain prior treatments including systemic therapy for RCC. Pregnant individuals, those with immunodeficiency, chronic intestinal diseases, active infections requiring systemic therapy, or a history of serious autoimmune disease are excluded.
What is being tested?
The study tests if Fecal Microbiota Transplantation (FMT) can reduce the side effects of ipilimumab/nivolumab immunotherapy in kidney cancer patients. The goal is to allow patients to tolerate their cancer treatment better by altering gut bacteria before and during the first two cycles of this powerful but potentially toxic drug combination.
What are the potential side effects?
Potential side effects from FMT may include discomfort at administration site and changes in bowel habits. Immunotherapy drugs like ipilimumab/nivolumab can cause inflammation in organs, fatigue, skin reactions, hormonal gland problems like thyroid issues, and could worsen pre-existing autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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I can swallow pills.
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My kidney cancer has spread and this was confirmed through tissue testing.
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My kidney cancer is classified as intermediate or poor risk.
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My blood tests show my organs and bone marrow are working well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.
Select...
I have an autoimmune disease that needs steroids or other immune-suppressing drugs.
Select...
I cannot receive FMT due to specific health reasons.
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I have had lung inflammation treated with steroids or have it now.
Select...
I have had treatment for advanced kidney cancer that couldn't be surgically removed.
Select...
I have a long-term bowel disease.
Select...
I am currently being treated for an infection.
Select...
I have been diagnosed with an immune system disorder.
Select...
I am not on high-dose steroids or any immunosuppressive drugs.
Select...
I am currently using antibiotics or have used them in the last two weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 9 years (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 9 years (end of study)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment
Secondary study objectives
Changes in patient microbiome following FMT
Determine the effect on immune response
Health related quality of life
+4 moreOther study objectives
Assess the immune profile of the tumor
Overall survival
Progression-free survival
Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT0310684444%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Fatigue
6%
Vomiting
4%
Heart Burn
4%
Chills
4%
Yeast Infection
4%
Migraine
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Fecal microbiota transplantation combined with approved standard of care treatment with nivolumab and ipilimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2020
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
638 Previous Clinical Trials
409,635 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
15 Previous Clinical Trials
1,413 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,400 Total Patients Enrolled
Ricardo Fernandes, MDPrincipal InvestigatorLondon Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
1 Previous Clinical Trials
75 Total Patients Enrolled
Saman Maleki, PhDPrincipal InvestigatorLondon Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.I have not received a live vaccine in the last 4 weeks.I am able to care for myself but may not be able to do active work.I will not need any other cancer treatment during the study.My side effects from previous treatments are mild or gone.I had cancer before, but I've been free of it for 5 years after treatment.I have an autoimmune disease that needs steroids or other immune-suppressing drugs.My brain metastases are stable after treatment.I cannot receive FMT due to specific health reasons.My kidney cancer has spread and this was confirmed through tissue testing.I can swallow pills.I have had lung inflammation treated with steroids or have it now.The doctor can measure the disease.I have had treatment for advanced kidney cancer that couldn't be surgically removed.My kidney cancer is classified as intermediate or poor risk.I have a long-term bowel disease.I am currently being treated for an infection.I have been diagnosed with an immune system disorder.I am not on high-dose steroids or any immunosuppressive drugs.My blood tests show my organs and bone marrow are working well.I am currently using antibiotics or have used them in the last two weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Fecal Microbiota Transplantation
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.