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SNCTP000004815 | NCT05273255 | BASEC2021-02036

Stuhltransplantation (Fäkale Mikrobiota Transplantation – FMT) für Patienten mit bösartigen Tumoren, die nicht auf die Krebsimmuntherapie ansprechen

Data source: BASEC (Imported from 08.11.2024), WHO (Imported from 07.11.2024)
Changed: Nov 7, 2024, 1:00 AM
Disease category: Other Cancer, Pancreatic Cancer, Prostate Cancer, Bladder Cancer, Colon and Rectal Cancer, Kidney Cancer, Breast Cancer, Melanoma, Lung Cancer

Brief description of trial (Data source: BASEC)

In dieser klinischen Studie wird untersucht, ob eine Stuhltransplantation (fäkale Mikrobiota-Transplantation - FMT) von Patienten, die auf eine Krebsimmuntherapie ansprechen (FMT-Spender), das Darm-Mikrobiom von Patienten mit bösartien Erkrankungen, die nicht auf eine Krebsimmuntherapie ansprechen (FMT-Empfänger) verändern kann und sie damit ebenfalls zu Ansprechern machen kann. Dieser Ansatz wird für verschiedene Krebsarten getestet. Dabei wird auch untersucht, wodurch ein möglicher Therapieerfolg beeinflusst wird, z. B. durch Untersuchung der Zusammensetzung des transplantierten Mikrobioms im Stuhl des Spenders oder der Veränderungen des Immunsystems beim Empfänger des Stuhls. Unser übergeordnetes Ziel ist es, spezifische Bakterienstämme zu identifizieren, die zukünftig in der Krebstherapie für einen personalisierten Therapieansatz verwendet werden können.

Health conditions investigated(Data source: BASEC)

FMT Spender: Solide Tumore im Stadium III oder IV, die auf eine Krebsimmuntherapie ansprechen. FMT Empfänger: Tumore im Stadium IV, die nach mindestens einem Zyklus der Krebsimmuntherapie nicht ausreichend auf die Behandlung ansprechen.

Health conditions (Data source: WHO)

Cancer;Fecal Microbiota Transplantation;Immune Checkpoint Inhibitors;Immunotherapy

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Untersucht wird die fäkale Mikrobiota Transplantation (FMT), bei welcher der Stuhl des Spenders während einer Koloskopie im Darm des Empfängers deponiert wird.

Interventions (Data source: WHO)

Biological: Fecal Microbiota Transplantation (FMT)

Criteria for participation in trial (Data source: BASEC)

1. FMT-Spender: Patienten und Patientinnen, die mindestens 18 Jahre alt sind, und deren solide Tumoren im Stadium III oder IV (metastasierend) mit einer Krebsimmuntherapie behandelt werden und bei denen ein dauerhaftes partielles oder vollständiges Ansprechen erzielt wurde.
2. FMT-Empfänger: Krebspatientinnen und -patienten, die mindestens 18 Jahre alt sind und deren Tumor im Stadium IV nach mindestens einem vollständigen Zyklus der Krebsimmuntherapie nicht ausreichend angesprochen hat (stabile Erkrankung oder Nichtansprechen).

Exclusion criteria (Data source: BASEC)

FMT-Spender: Patientinnen und Patienten, die kürzlich mit Antibiotika behandelt wurden und/oder an gastrointestinalen, autoimmunen, neurologischen oder bestimmten infektiösen Erkrankungen leiden, werden als potenzielle Teilnehmer ausgeschlossen.
FMT-Empfänger: Patientinnen und Patienten mit absoluten Kontraindikationen für die Koloskopie, mit Hirnmetastasen, Patienten die derzeit mit Antibiotika behandelt werden und an Immunschwäche, schweren Nahrungsmittelallergien oder bestimmten Infektionskrankheiten leiden, werden als potenzielle Teilnehmer ausgeschlossen.

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: N/A
Minimum age: 18 Years
General inclusion criteria for all participants:

- Patients, at minimum 18 years of age, male or female

- Signed informed consent obtained from subject according to local regulations

- ECOG score at the time of study enrolment 0-1

The investigators will include patients/individuals fulfilling inclusion criteria for one
of the following groups:

1. Patients with refractory malignancy (FMT-Recipients). The investigators will recruit
25 individuals with stable or progressing disease after minimum of 1 cycle of CI.

2. Patients with malignancy in remission after ICI therapy (FMT-Donors). The
investigators will recruit 5 patients willing to donate stool samples for the study.

Inclusion criteria FMT-Recipients:

1. Histologically or cytologically confirmed diagnosis of malignancy

2. Currently treated with CI with at least 1 cycle completed. Multiple active
malignancies are allowed.

3. 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).

4. 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.

5. Willingness to receive FMT administered via colonoscopy and undergo necessary bowel
preparation pre-procedure.

6. Demonstrate adequate organ function as defined below, all screening labs should be
performed within 28 days of FMT intervention.

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

7. 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.

8. Female subjects of childbearing potential must be willing to use a clinically
established method of contraception before the FMT procedure.

Inclusion criteria FMT-Donors:

1. Documented history of malignancy treated with ICI therapy.

2. 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.

3. Willingness to complete donor-specific questionnaire.

4. Willingness to complete donor-specific serologic and stool testing to evaluate
infectious agents.

5. Patient tested negatively for all infectious agents specified.

6. Willingness to provide multiple stool samples, until total amount reaches 170g.

7. Absence of major gastrointestinal symptoms 3 months prior to stool donation
(including frequent vomiting, diarrhea, bleeding, constipation).

Exclusion criteria FMT Recipients:

1. Presence of absolute contra-indications to colonoscopy and/or FMT administration:

- Toxic megacolon

- Inflammatory bowel disease

- Anatomic contra-indications to colonoscopy

- Colectomy

2. 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.

3. Currently under any form of systemic antibiotics.

4. 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).

5. Severe anaphylactic reaction to any food (food allergies).

6. Had a severe hypersensitivity reaction to propofol.

7. Has serious concomitant illnesses. The eligibility can be granted by the treating
investigator on individual bases.

8. Has HIV infection or AIDS-related illness.

9. 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.

10. 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.

11. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

12. Females who are pregnant or breastfeeding.

13. Active central nervous system (CNS) metastases and/or leptomeningeal involvement.

Exclusion criteria FMT Donors:

1. History or current antibiotic treatment during the 2 month preceding donation.

2. 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.

3. History or current symptomatic autoimmune illness.

4. History or current documented neurologic or neurodevelopmental disorders.

5. History or current metabolic syndrome, obesity (BMI of >35), or moderate-to-severe
malnutrition (as assessed clinically).

6. History or current infection with HIV (or AIDS-related illness).

7. Positive serological tests for Syphilis, HAV, HBV or HCV.

8. Positive stool test for Escherichia coli, Vancomycin-resistant Enterococcus,
Norovirus, C. difficile, Yersinia, Campylobacter, Shigella or Salmonella.

9. Positive stool test for parasites.

10. 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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT05273255

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05273255
Further information on trial

Recruitment status

Completed

Academic title (Data source: WHO)

An Open Label Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients with Malignancies Not Responding to Cancer Immunotherapy (CI)

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Change in the intestinal microbiome community

Secundary end point (Data source: WHO)

Adverse Events Related to Study Intervention;Objective Response Rate;Progression-Free Survival;Overall Survival;Correlation between specific immune cell presence in blood/colon tissue and therapy response;CI response rate upon microbiome change;Quality of life based on the questionnaire

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Prof. Dr. Michael Scharl
+41 44 255 3419
Michael.Scharl@usz.ch

Contact for general information (Data source: WHO)

Michael Scharl, Prof. Dr.
University Hospital Zurich, University of Zurich

Contact for scientific information (Data source: WHO)

Michael Scharl, Prof. Dr.
University Hospital Zurich, University of Zurich

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

14.01.2022

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2021-02036

Secondary ID (Data source: WHO)

FMT-Malignancies
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