CancerNCT05273255
Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy
A study testing Fecal Microbiota Transplantation (FMT) in people with Cancer and Fecal Microbiota Transplantation, run by Michael Scharl at 1 site in Switzerland.
Trial summary
The intestinal microbiome forms a symbiotic relationship with the human host and continuously interacts with its immune system. Specific compositions of the intestinal microbiome in patients with cancer have been linked to the response to therapy with cancer immunotherapies (CI), such as immune checkpoint inhibitors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Fecal Microbiota Transplantation, Immune Checkpoint Inhibitors
- What is being tested?
- Fecal Microbiota Transplantation (FMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Mar 2022to 24 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed diagnosis of malignancy
- Currently treated with CI with at least 1 cycle completed. Multiple active malignancies are allowed.
- Patient with stable or progressive disease as shown at the most recent staging method and decided by the treating investigator (based on the radiologic assessment).
- Must be CI refractory/resistant as judged by the treating physician based on a recent CT or PET-CT (PET-MRI) scan not older than 8 weeks before screening visit.
- Willingness to receive FMT administered via colonoscopy and undergo necessary bowel preparation pre-procedure.
- Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of FMT intervention.
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- Following laboratory parameters need to be met:
- Platelet count ≥ 50 x 10^9 / L
- Hemoglobin ≥ 8.5 g/dL
- Prothrombin time (PT)-international normalized ration (INR) ≤ 1.5
- Female subject of childbearing potential should have a negative urine pregnancy within minimum 8 hours prior to receiving the study intervention (FMT). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential must be willing to use a clinically established method of contraception before the FMT procedure.
- Documented history of malignancy treated with ICI therapy.
- Featuring partial or complete response of the malignancy as assessed by radiologic examination with a minimum duration of remission lasting ≥12 months measured since initiation of therapy.
- Willingness to complete donor-specific questionnaire.
- Willingness to complete donor-specific serologic and stool testing to evaluate infectious agents.
- Patient tested negatively for all infectious agents specified.
- Willingness to provide multiple stool samples, until total amount reaches 170g.
- Absence of major gastrointestinal symptoms 3 months prior to stool donation (including frequent vomiting, diarrhea, bleeding, constipation).
Who cannot join
- Presence of absolute contra-indications to colonoscopy and/or FMT administration:
- Toxic megacolon
- Inflammatory bowel disease
- Anatomic contra-indications to colonoscopy
- Colectomy
- Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.
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- Currently under any form of systemic antibiotics.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (> 10 mg prednisone daily or equivalent).
- Severe anaphylactic reaction to any food (food allergies).
- Had a severe hypersensitivity reaction to propofol.
- Has serious concomitant illnesses. The eligibility can be granted by the treating investigator on individual bases.
- Has HIV infection or AIDS-related illness.
- Has active infection of HAV, HBV or HCV. Patients with a history of Hepatitis B/C infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with Principal Investigator.
- Patient has received a live vaccine within 4 weeks prior to the first dose of treatment. Seasonal influenza vaccines or COVID-19 vaccines for injection are generally inactivated virus vaccines and are allowed.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Females who are pregnant or breastfeeding.
- Active central nervous system (CNS) metastases and/or leptomeningeal involvement.
- History or current antibiotic treatment during the 2 month preceding donation.
- History or current intrinsic gastrointestinal illnesses, including inflammatory bowel disease, irritable bowel syndrome, chronic diarrheal disorder (e.g. celiac disease or microscopic colitis) or major gastrointestinal surgical procedures.
- History or current symptomatic autoimmune illness.
- History or current documented neurologic or neurodevelopmental disorders.
- History or current metabolic syndrome, obesity (BMI of >35), or moderate-to-severe malnutrition (as assessed clinically).
- History or current infection with HIV (or AIDS-related illness).
- Positive serological tests for Syphilis, HAV, HBV or HCV.
- Positive stool test for Escherichia coli, Vancomycin-resistant Enterococcus, Norovirus, C. difficile, Yersinia, Campylobacter, Shigella or Salmonella.
- Positive stool test for parasites.
- Positive Sars-CoV-2 screening/testing (active infection).
- Subjects whose pregnancy test on Screening visit shows a positive result, have to be excluded from the study. All pregnancies occurring during the treatment phase of the study and within 30 days after discontinuation of study medication have to be reported to the Investigator-Sponsor within one working day of the investigational sites knowledge of the pregnancy on the Initial Pregnancy Report Form. Female Subjects should be informed in this way before signing the informed consent form. Female partners of male participants may get pregnant without any consequence to the male participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients With Malignancies Not Responding to Cancer Immunotherapy (CI)
The intestinal microbiome forms a symbiotic relationship with the human host and continuously interacts with its immune system. Specific compositions of the intestinal microbiome in patients with cancer have been linked to the response to therapy with cancer immunotherapies (CI), such as immune checkpoint inhibitors (ICIs). The investigators hypothesize that fecal microbiota transplantation (FMT) from patients being responsive to ICI therapy (FMT-Donor) can modulate the intestinal microbiome of patients with CI-refractory malignancies (FMT-Recipients) and render them into responders. Successful proof-of-concept studies showed that reversion from an ICI non-responsive to a responsive disease is indeed possible in melanoma patients after FMT. This trial expands the FMT intervention to patients with any malignancy treated with cancer immunotherapy as a standard of care, to demonstrate the feasibility of this FMT approach as a novel option in cancer therapy.
- Being tested
- Fecal Microbiota Transplantation (FMT)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)Biological
Single-dose of fecal microbiota from FMT-Donor transplanted endoscopically to FMT-Recipient in between two cycles of CI.
| Study group | Role | What they receive |
|---|---|---|
| FMT-Recipients | Experimental | FMT-Recipients are patients with stage IV cancer, who have not sufficiently responded (stable disease or non-response) after at least 1 full cycle of CI. These patients will undergo the FMT procedure after the colon cleansing performed per routine treatment protocols at the Departement of Gastroenterology at the University Hospital of Zürich.
The stool is donated by FMT-Donors, which are patients with any solid cancer stage III or IV cancers, who received any ICI-Therapy and have experienced a durable partial or complete response.
FMT infusate will be administered via colonoscopy. Receives: Biological: Fecal Microbiota Transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intestinal microbiome community
Mean change from baseline of bacterial species compared with 24 weeks post fecal microbiota transplantation (FMT).
Measured: up to 24 weeks
Secondary outcomes (7)
Adverse Events Related to Study Intervention
Number of adverse events and serious adverse events related definitely to fecal microbiota transplantation (FMT).
Measured: up to 24 weeks
Objective Response Rate
Percentage of participants that achieved an objective response as per Response Evaluation Criteria in Solid Tumours (iRECIST) treated with immunotherapy.
Measured: up to 24 weeks
Progression-Free Survival
Time, measured in days, between the fecal microbiota transplantation (FMT) and disease progression as per Response Evaluation Criteria in Solid Tumours (iRECIST) treated with immunotherapy.
Measured: up to 24 weeks
Overall Survival
The length of time (in days) from study intervention that participants remain alive.
Measured: up to 24 weeks
Correlation between specific immune cell presence in blood/colon tissue and therapy response
Number of immune cells in peripheral blood, intestinal and tumor tissue at the time of stool donation, baseline and after 24 weeks post fecal microbiota transplantation (FMT).
Measured: up to 24 weeks
CI response rate upon microbiome change
Number of participants with specific bacteria species that positively correlate with the favorable response to cancer immunotherapy.
Measured: up to 24 weeks
Quality of life based on the questionnaire
Scoring based on "European Organization for Research and Treatment of Cancer 30-item quality of life questionnaire (EORTC QLQ C-30)".
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start14 Mar 2022
- Primary completion4 Jan 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Scharl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Scharl, University of Zurich
- Investigators
- Michael Scharl, Prof. Dr., Principal investigator, University Hospital Zurich, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273255
- Sponsor's protocol ID
- FMT-Malignancies
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients With Malignancies Not Responding to Cancer Immunotherapy (CI)
- ClinicalTrials.gov ID
- NCT05273255
- Acronym / sponsor ID
- FMT-Malignancies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Michael ScharlUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 10 Mar 2022 (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.
The intestinal microbiome forms a symbiotic relationship with the human host and continuously interacts with its immune system. Specific compositions of the intestinal microbiome in patients with cancer have been linked to the response to therapy with cancer immunotherapies (CI), such as immune checkpoint inhibitors (ICIs). The investigators hypothesize that fecal microbiota transplantation (FMT) from patients being responsive to ICI therapy (FMT-Donor) can modulate the intestinal microbiome of patients with CI-refractory malignancies (FMT-Recipients) and render them into responders. Successful proof-of-concept studies showed that reversion from an ICI non-responsive to a responsive disease is indeed possible in melanoma patients after FMT. This trial expands the FMT intervention to patients with any malignancy treated with cancer immunotherapy as a standard of care, to demonstrate the feasibility of this FMT approach as a novel option in cancer therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT-Recipients | Experimental | Biological: Fecal Microbiota Transplantation (FMT)FMT-Recipients are patients with stage IV cancer, who have not sufficiently responded (stable disease or non-response) after at least 1 full cycle of CI. These patients will undergo the FMT procedure after the colon cleansing performed per routine treatment protocols at the Departement of Gastroenterology at the University Hospital of Zürich. The stool is donated by FMT-Donors, which are patients with any solid cancer stage III or IV cancers, who received any ICI-Therapy and have experienced a durable partial or complete response. FMT infusate will be administered via colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed diagnosis of malignancy
- Currently treated with CI with at least 1 cycle completed. Multiple active malignancies are allowed.
- Patient with stable or progressive disease as shown at the most recent staging method and decided by the treating investigator (based on the radiologic assessment).
- Must be CI refractory/resistant as judged by the treating physician based on a recent CT or PET-CT (PET-MRI) scan not older than 8 weeks before screening visit.
- Willingness to receive FMT administered via colonoscopy and undergo necessary bowel preparation pre-procedure.
Key exclusion criteria (28 listed)
- Presence of absolute contra-indications to colonoscopy and/or FMT administration:
- Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.
- Currently under any form of systemic antibiotics.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (> 10 mg prednisone daily or equivalent).
- Severe anaphylactic reaction to any food (food allergies).
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 Transplantation (FMT)Single-dose of fecal microbiota from FMT-Donor transplanted endoscopically to FMT-Recipient in between two cycles of CI. | Biological | FMT-Recipients |
Primary outcome
Change in the intestinal microbiome community
Time frame: up to 24 weeks
Mean change from baseline of bacterial species compared with 24 weeks post fecal microbiota transplantation (FMT).
7 secondary outcomes
Adverse Events Related to Study Intervention
Time frame: up to 24 weeks
Objective Response Rate
Time frame: up to 24 weeks
Progression-Free Survival
Time frame: up to 24 weeks
Overall Survival
Time frame: up to 24 weeks
Correlation between specific immune cell presence in blood/colon tissue and therapy response
Time frame: up to 24 weeks
CI response rate upon microbiome change
Time frame: up to 24 weeks
Quality of life based on the questionnaire
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
Michael Scharl, Prof. Dr. principal investigator
University Hospital Zurich, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation (FMT) in people with Cancer and Fecal Microbiota Transplantation, run by Michael Scharl at 1 site in Switzerland.
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 19 inclusion and 28 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: finished, as of the sponsor's last update on 28 Mar 2025. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the intestinal microbiome community (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.