Renal Cell CarcinomaPhase 1PERFORMNCT04163289

Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation

A Phase 1 study testing Fecal Microbiota Transplantation in people with Renal Cell Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Carcinoma
What is being tested?: Fecal Microbiota Transplantation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCanada
Study dates: 23 Jan 2020to Nov 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have histologically confirmed diagnosis of advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
Intermediate or poor risk RCC as defined by International Metastatic RCC Database Consortium (IMDC criteria, Heng et al 2009):
Karnofsky performance status (KPS) < 80%
Less than 1 year form initial RCC diagnosis (including original localized disease if applicable) to systemic treatment
Hemoglobin < lower limit of normal (LLN)
Corrected calcium > 10 mg/dL

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Absolute neutrophil count (ANC) > upper limit of normal (ULN)
Platelet count > ULN
Age ≥ 18 years.
Karnofsky Performance Status (KPS) ≥70%
Evaluable disease determined by the Investigator
Ability to ingest capsules
Able to provide written informed consent
Understand non-infectious risks associated with FMT administration and that the long term data regarding safety risks of FMT are lacking
Recovery to baseline or ≤ Grade 1 CTCAE v 4.0 from toxicities related to any prior treatments, unless AEs are clinically non-significant
Adequate organ and marrow function, based upon meeting all the following laboratory parameters:
Absolute neutrophil count (ANC) ≥ 1500/μL (≥ 1.5 x 109/L) without granulocyte colony-stimulating factor support within 4 weeks before screening laboratory sample collection.
White blood cell count ≥ 2000/μL (≥ 2.0 x 109/L)
Platelets ≥ 100,000/μL (≥ 100 x 109/L) without transfusion within 4 weeks before screening laboratory sample collection.
Hemoglobin ≥ 9 g/dL (≥ 90 g/L) without transfusion within 4 weeks before screening laboratory sample collection.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.
Total bilirubin ≤ 1.5 × ULN (with the exception that total bilirubin for subjects with Gilbert's disease ≤ 3 × ULN).
Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance ≥ 40 mL/min (≥ 0.67 mL/sec) using the Cockcroft-Gault equation (see for Cockcroft-Gault formula).
Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g

Who cannot join

Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents.
Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible for the study.
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with signing the informed consent through 6 months after FMT.
Diagnosis of immunodeficiency (e.g. HIV, transplantation)
Receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. Adrenal replacement steroids doses > 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic steroids for allergic situations (e.g. contrast allergy) is also permitted. Patients who require inhaled, intranasal, intra-articular, or topical steroids are allowed. Intermittent use of bronchodilators or local steroid injections are not excluded from the study
Ongoing use of antibiotics or previous use of antibiotics in the last two weeks prior to the initial FMT procedure

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Presence of a chronic intestinal disease (e.g. Celiac, malabsorption, colonic tumor)
Presence of absolute contra-indications to FMT administration
Toxic megacolon
Severe dietary allergies (e.g. shellfish, nuts, seafood)
Inflammatory bowel disease
Expected to require any other form of systemic or localized anti-neoplastic therapy while on study. Treatment with either bisphosphonate or denosumab for bone metastatic disease is allowed
Known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the patient has undergone potentially curative therapy with no evidence of that disease for five years
o NOTE: This time requirement also does not apply to patients who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cancers including cervical cancer, breast cancer, melanoma, or other in situ cancers.
Active central nervous system (CNS) metastases and/or leptomeningeal involvement, unless treated with radiotherapy and/or radiosurgery with stable disease for at least 4 weeks prior to study entry after radiotherapy or at least 8 weeks prior to study entry after major surgery
Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
o Patients with vitiligo, type I diabetes, resolved childhood asthma/atopy are exceptions to this rule
A history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Serious concomitant illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders
o This includes HIV or AIDS-related illness, or active HBV and HCV
Active infection requiring systemic therapy.
Patient has received a live vaccine within 4 weeks prior to the first dose of treatment
o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, N6A 5W9

Other trials in Canada

About this study

Official title: Preventing Immune-Related Adverse Events in Renal Cell Carcinoma Patients Treated With Combination Immunotherapy Using Fecal Microbiota Transplantation

Cancer immunotherapy has been largely adopted in oncology patient management in the last decade. The deep and long responses to immunotherapy have accelerated the approval of these drugs across multiple disease sites. However, these agents can also be toxic to patients, meaning, the patient will have to discontinue treatment and outcomes could be negatively affected. Recently, a combination of two immunotherapy drugs, ipilimumab and nivolumab (ipi/nivo), has been approved for the treatment of intermediate and poor-risk renal cell carcinoma (RCC) patients. This powerful combination provides survival benefit, however, it can also be highly toxic leading to discontinuation of this treatment.

There has been some evidence that these otherwise toxic drugs can be better tolerated by altering the composition of the patients gut bacteria to create a more diverse and healthy microbiome. The current study will involve Fecal Microbiota Transplantation (FMT) before the start of the immunotherapy combination, and during the first two cycles of ipilimumab treatment (the more toxic agent) as supportive therapy to prevent toxicity associated with the ipi/nivo combination.

The goal of this project is to study the safety of such FMT combination treatment and reduce occurrence of immune-related toxicities in patients, allowing them to continue their cancer treatments in the hopes of a better outcome. The investigators will also be looking at changes in the immune populations, microbiome profile of patients, response to treatment, and patient survival as secondary objectives.

Conditions: Renal Cell Carcinoma
Being tested: Fecal Microbiota Transplantation
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal Microbiota TransplantationDrug
Fecal microbiota transplantation is the process of administering stool samples derived from healthy donors, which have been processed and prepared into capsules. Capsules will be taken 7 days or more prior to the first treatment with nivolumab and ipilimumab, and 1 to 3 days prior to the next 2 treatments with nivolumab and ipilimumab.

Study groups in NCT04163289
Study group	Role	What they receive
Fecal Microbiota Transplantation	Experimental	Fecal microbiota transplantation combined with approved standard of care treatment with nivolumab and ipilimumab. Receives: Drug: Fecal Microbiota Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment
Occurence of grade 3 or higher immune-related colitis from the start of treatment with ipilimumab and nivolumab to 120 days after completion of treatment. Colitis will be graded using the Common Toxicity Criteria for Adverse Events version 4.02.
Measured: 28 months

Secondary outcomes (7)

Incidence of any immune-related adverse event associated with ipilimumab/nivolumab treatment
Incidence of any immune-related adverse event grade 3 or higher from the start of treatment with ipilimumab and nivolumab to 120 days after completion of treatment. Adverse events will be graded using the Common Toxicity Criteria for Adverse Events version 4.02.
Measured: 28 months
Proportion of patients who discontinue treatment because of immune-related adverse events
Measured from the start of treatment with ipilimumab and nivolumab to 120 days after completion of treatment.
Measured: 28 months
Objective response rate
Objective response rate is defined as the proportion of patients achieving a complete response (disappearance of all lesions) and a partial response (30% or more decrease in the sum diameters of the target lesions) (Eisenhauer et al., 2009). Objective response rate will be measured using RECIST criteria version 1.1.
Measured: Approximately 9 years (end of study)
Changes in patient microbiome following FMT
Changes in patient microbiome will be determined by analysis of gut bacterial composition in patient stool samples at baseline and post-FMT.
Measured: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Success rate of the fecal microbiota transplant
Success will be determined by comparing the make-up of the healthy donor microbiome to the patient's microbiome, using stool samples.
Measured: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Determine the effect on immune response
Effects on the patient immune response will be assessed by examining changes in peripheral blood immune cells, chemokines, cytokines, and other immune and tumor biomarkers.
Measured: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Health related quality of life
Patient reported quality of life will be measured using the standardized questionnaire, European Organization for Research and Treatment of Cancer (EORTC) EQ-5D-5L.
Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 2020Nov 2028

First posted14 Nov 2019
Study start23 Jan 2020
Primary completion28 Nov 2023
Study completionNov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04163289
Sponsor's protocol ID: PERFORM Renal
Acronym: PERFORM
Status last verified: Sep 2026
First submitted: 12 Nov 2019
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
PubMed 19097774
Fernandes R, Jabbarizadeh B, Rajeh A, Hong MMY, Baines KJ, Ernst S, Winquist E, Ali AS, Penny S, Figueredo R, Parvathy SN, Lenehan JG, Pinto DM, Silverman MS, Maleki Vareki S. Fecal microbiota transplantation plus immunotherapy in metastatic renal cell carcinoma: the phase 1 PERFORM trial. Nat Med. 2026 Apr;32(4):1325-1336. doi: 10.1038/s41591-025-04183-8. Epub 2026 Jan 28.
PubMed 41606120
Ninkov M, Schmerk CL, Moradizadeh M, Parvathy SN, Figueredo R, Burton JP, Silverman MS, Fernandes R, Maleki Vareki S, Haeryfar SMM. Improved MAIT cell functions following fecal microbiota transplantation for metastatic renal cell carcinoma. Cancer Immunol Immunother. 2023 May;72(5):1247-1260. doi: 10.1007/s00262-022-03329-8. Epub 2022 Nov 18.
PubMed 36396738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Immune-Related Adverse Events in Renal Cell Carcinoma Patients Treated With Combination Immunotherapy Using Fecal Microbiota Transplantation
ClinicalTrials.gov ID: NCT04163289
Acronym / sponsor ID: PERFORM / PERFORM Renal
Conditions: Renal Cell Carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (actual)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
Collaborators: Academic Medical Organization of Southwestern Ontario
Study start: 23 Jan 2020 (actual)
Primary completion: 28 Nov 2023 (actual)
Study completion: Nov 2028 (estimated)
First posted: 14 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fecal Microbiota Transplantation	Experimental	Drug: Fecal Microbiota TransplantationFecal microbiota transplantation combined with approved standard of care treatment with nivolumab and ipilimumab.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Patients must have histologically confirmed diagnosis of advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma
Intermediate or poor risk RCC as defined by International Metastatic RCC Database Consortium (IMDC criteria, Heng et al 2009):
Age ≥ 18 years.
Karnofsky Performance Status (KPS) ≥70%
Evaluable disease determined by the Investigator

Key exclusion criteria (24 listed)

Prior systemic therapy for unresectable locally advanced or metastatic RCC including investigational agents.
Radiation therapy for bone metastasis within 2 weeks, or any other radiation therapy within 4 weeks prior to study entry. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible for the study.
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with signing the informed consent through 6 months after FMT.
Diagnosis of immunodeficiency (e.g. HIV, transplantation)
Receiving systemic steroid therapy (>10mg prednisone daily or equivalent) or any other form of immunosuppressive therapy prior to trial treatment. Adrenal replacement steroids doses > 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic steroids for allergic situations (e.g. contrast allergy) is also permitted. Patients who require inhaled, intranasal, intra-articular, or topical steroids are allowed. Intermittent use of bronchodilators or local steroid injections are not excluded from the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fecal Microbiota TransplantationFecal microbiota transplantation is the process of administering stool samples derived from healthy donors, which have been processed and prepared into capsules. Capsules will be taken 7 days or more prior to the first treatment with nivolumab and ipilimumab, and 1 to 3 days prior to the next 2 treatments with nivolumab and ipilimumab.	Drug	Fecal Microbiota Transplantation

Primary outcome

Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment
Time frame: 28 months
Occurence of grade 3 or higher immune-related colitis from the start of treatment with ipilimumab and nivolumab to 120 days after completion of treatment. Colitis will be graded using the Common Toxicity Criteria for Adverse Events version 4.02.

7 secondary outcomes

Incidence of any immune-related adverse event associated with ipilimumab/nivolumab treatment
Time frame: 28 months
Proportion of patients who discontinue treatment because of immune-related adverse events
Time frame: 28 months
Objective response rate
Time frame: Approximately 9 years (end of study)
Changes in patient microbiome following FMT
Time frame: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Success rate of the fecal microbiota transplant
Time frame: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Determine the effect on immune response
Time frame: At baseline (prior to FMT) and prior to the 1st, 2nd, 3rd and fourth dose of immunotherapy (approximately 1 week, 3 weeks, 7 weeks , and 10 weeks post FMT).
Health related quality of life
Time frame: 30 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
Background: PubMed 19097774Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
Derived from this study: PubMed 41606120Fernandes R, Jabbarizadeh B, Rajeh A, Hong MMY, Baines KJ, Ernst S, Winquist E, Ali AS, Penny S, Figueredo R, Parvathy SN, Lenehan JG, Pinto DM, Silverman MS, Maleki Vareki S. Fecal microbiota transplantation plus immunotherapy in metastatic renal cell carcinoma: the phase 1 PERFORM trial. Nat Med. 2026 Apr;32(4):1325-1336. doi: 10.1038/s41591-025-04183-8. Epub 2026 Jan 28.
Derived from this study: PubMed 36396738Ninkov M, Schmerk CL, Moradizadeh M, Parvathy SN, Figueredo R, Burton JP, Silverman MS, Fernandes R, Maleki Vareki S, Haeryfar SMM. Improved MAIT cell functions following fecal microbiota transplantation for metastatic renal cell carcinoma. Cancer Immunol Immunother. 2023 May;72(5):1247-1260. doi: 10.1007/s00262-022-03329-8. Epub 2022 Nov 18.
Individual participant dataSharing planned: No

Related trials for Renal Cell Carcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
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Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ricardo Fernandes, MD principal investigator

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

Saman Maleki, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of immune-related colitis associated with ipilimumab/nivolumab treatment (time frame: 28 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04163289, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.