Actively Recruiting
FMT to Convert Response to Immunotherapy
Led by The Netherlands Cancer Institute · Updated on 2025-03-10
24
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study the aim is to investigate whether transfer of the microbiota of either responder or non-responder patients via fecal microbiotica transplantation (FMT) can convert the response to immunotherapy in immune checkpoint inhibitors (ICI) refractory metastatic melanoma patients. This is a randomized double-blind intervention phase Ib/IIa trial in ICI refractory metastatic melanoma patients receiving either FMT of an ICI responding or FMT from an ICI non-responding donor, in combination with ICI. Following randomization, patients will receive vancomycin 250 mg, four times daily for 4 days (day -5 up until day -2), and undergo bowel clearance on day -1 (in total 1L MoviPrep). The FMT, either derived from donor group R (who showed a good response on anti-PD-1 therapy) or donor group NR (who showed progression on anti-PD-1 therapy), will be performed by a gastroenterologist using esophagogastroduodenoscopy. A total amount of 198mL (containing a total of 60 gram feces) will be used for transplantation. Anti-PD-1 treatment will be continued according to the patient's regular treatment schedule. Evaluation of safety and response to treatment will be performed.
CONDITIONS
Official Title
FMT to Convert Response to Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients should be 18 years or older
- Patients have pathologically confirmed advanced stage cutaneous melanoma (stage III or IV) requiring systemic treatment with anti-PD-1
- For stage IV disease, only patients with M1a or M1b disease are eligible
- Patients have confirmed disease progression (≥20% increase by RECIST 1.1) on two scans at least four weeks apart while on anti-PD-1 treatment
- The second scan must be within 3 weeks prior to signing informed consent
- Patients must have measurable disease per RECIST 1.1 criteria
- Patients have an ECOG performance status of 0-1
- Patients have a life expectancy of more than 3 months
- Patients have adequate organ function based on lab tests including ALAT/ASAT less than three times the upper limit of normal, creatinine clearance 50 ml/min or higher, total bilirubin ≤20 micromol/L (or ≤50 micromol/L if Gilbert's Syndrome)
- Patients have an LDH level of 1 times ULN or less
- Patients of both genders must agree to use highly effective birth control during treatment
- Patients must be able to understand and sign the informed consent document
You will not qualify if you...
- Patients with acral, uveal, mucosal melanoma, or unknown primary melanoma
- Patients who have received melanoma treatment other than anti-PD-1
- Stage IV patients with M1c or M1d disease
- Patients with autoimmune diseases including inflammatory bowel disease, ulcerative colitis, or Crohn's disease (except Hashimoto thyroiditis, vitiligo, history of psoriasis without active disease)
- Patients with grade 3 or 4 immune-related adverse events requiring active immunosuppressive medication, except stable endocrinopathies on hormone replacement
- Patients with brain or leptomeningeal metastasis
- Patients with elevated LDH levels
- Patients who had major gastric, esophageal, or bowel surgery (like Whipple procedure or subtotal colectomy)
- Patients with severe food allergies (e.g., nuts, shellfish)
- Patients with swallowing disorders or bowel passage problems such as ileus, fistulas, or perforation
- Patients unable to swallow 2 liters of bowel lavage solution
- Patients with life expectancy less than three months
- Patients with severe cardiac or pulmonary conditions as judged by the investigator
- Women who are pregnant or breastfeeding
- Patients with active systemic infections, coagulation disorders, or other major illnesses
- Patients with other cancers unless adequately treated and cancer-related life expectancy over 5 years
- Patients treated with antibiotics in the three months before enrollment or expected to need antibiotics during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX
Actively Recruiting
Research Team
J
John Haanen, Prof
CONTACT
F
Femke Burgers, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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