FMT to Convert Response to Immunotherapy

Recruiting Phase 1 Phase 2 Interventional Study
Melanoma Stage III Melanoma Stage IV
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
The Netherlands Cancer Institute · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 * In case of stage IV disease, only patients with M1a or M1b disease are eligible. * Patients have c…
Contacts

John Haanen, Prof

+31205129111

j.haanen@nki.nl

CONTACT

Femke Burgers, MD

+31205129111

f.burgers@nki.nl

CONTACT