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Fecal Microbiota Transplantation for Kidney Cancer (PERFORM Trial)

Phase 1
Waitlist Available
Led By Ricardo Fernandes, MD
Research Sponsored by Lawson Health Research Institute
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 below
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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:
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I haven't had radiation for bone metastasis in the last 2 weeks or any radiation in the last 4 weeks.
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I have an autoimmune disease that needs steroids or other immune-suppressing drugs.
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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.
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I have had treatment for advanced kidney cancer that couldn't be surgically removed.
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I have a long-term bowel disease.
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I am currently being treated for an infection.
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I have been diagnosed with an immune system disorder.
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I am not on high-dose steroids or any immunosuppressive drugs.
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I am currently using antibiotics or have used them in the last two weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 9 years (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 9 years (end of study) for reporting.

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 more
Other 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 • NCT03106844
44%
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?

Academic Medical Organization of Southwestern OntarioOTHER
15 Previous Clinical Trials
1,413 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
677 Previous Clinical Trials
421,607 Total Patients Enrolled
Ricardo Fernandes, MDPrincipal InvestigatorLawson Health Research Institute
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Fecal Microbiota Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT04163289 — Phase 1
Kidney Cancer Research Study Groups: Fecal Microbiota Transplantation
Kidney Cancer Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT04163289 — Phase 1
Fecal Microbiota Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04163289 — Phase 1
~3 spots leftby Nov 2025
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