Fecal Microbiota Transplantation in Patients With Malignancies Not Responding to Cancer Immunotherapy
- Conditions
- Fecal Microbiota TransplantationCancerImmunotherapyImmune Checkpoint Inhibitors
- Interventions
- Biological: Fecal Microbiota Transplantation (FMT)
- Registration Number
- NCT05273255
- Lead Sponsor
- Michael Scharl
- Brief 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 (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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMT-Recipients 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.
- Primary Outcome Measures
Name Time Method Change in the intestinal microbiome community up to 24 weeks Mean change from baseline of bacterial species compared with 24 weeks post fecal microbiota transplantation (FMT).
- Secondary Outcome Measures
Name Time Method CI response rate upon microbiome change up to 24 weeks Number of participants with specific bacteria species that positively correlate with the favorable response to cancer immunotherapy.
Adverse Events Related to Study Intervention up to 24 weeks Number of adverse events and serious adverse events related definitely to fecal microbiota transplantation (FMT).
Objective Response Rate up to 24 weeks Percentage of participants that achieved an objective response as per Response Evaluation Criteria in Solid Tumours (iRECIST) treated with immunotherapy.
Progression-Free Survival up to 24 weeks 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.
Overall Survival up to 24 weeks The length of time (in days) from study intervention that participants remain alive.
Correlation between specific immune cell presence in blood/colon tissue and therapy response up to 24 weeks 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).
Quality of life based on the questionnaire up to 24 weeks Scoring based on "European Organization for Research and Treatment of Cancer 30-item quality of life questionnaire (EORTC QLQ C-30)".
Trial Locations
- Locations (1)
University of Zurich, University Hospital Zurich
🇨🇭Zurich, Switzerland