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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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