Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fecal Microbiota Transplant with Pembrolizumab · 1 trial · 1 indication
Number of patients with patients with objective responses (Complete Response (CR) + Partial Response (PR), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Fecal Microbiota Transplant (FMT) with Pembrolizumab | EXPERIMENTAL | The FMT along with an intestinal biopsy will be performed as outpatient by a gastroenterologist. The FMT is infused into the colon by performing a colonoscopy. FMT will be performed on Cycle 1 Day 1 and will take 15 to 30 minutes. Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT), and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4). |
| Name | Type | Description |
|---|---|---|
| Fecal Microbiota Transplant with Pembrolizumab | DRUG | FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1. Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4). |
Inclusion Criteria: * Have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma. Patient may not have a diagnosis of uveal or mucosal melanoma. * Have received any number of prior systemic therapies for metastatic disease. Prior radiation therapy (any numbe...
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Fecal microbiota transplant with pembrolizumab is an investigational combination approach studied in melanoma. It pairs pembrolizumab, a monoclonal antibody, with fecal microbiota transplant, which transfers gut bacteria from a donor. The combination was evaluated in a Phase 2 trial of 20 melanoma patients. Pembrolizumab is developed by Merck & Company, Inc.
It was studied for use in melanoma, a form of skin cancer. The Phase 2 trial enrolled 20 patients with melanoma in the United States. The study is completed, and the combination remains investigational rather than an approved melanoma treatment.
Merck & Company, Inc., which trades under the ticker MRK, is the developer associated with pembrolizumab in this combination. The fecal microbiota transplant component involves donor-derived gut bacteria rather than a company-manufactured product. Merck is the sponsor tied to the pembrolizumab portion of the regimen.
It is in Phase 2. The single registered trial, NCT03341143, is listed as Phase 2 and completed. It is not an FDA-approved treatment, and no active trials of this combination are currently listed. The study enrolled 20 patients with melanoma.
One trial is registered: NCT03341143, titled Fecal Microbiota Transplant (FMT) in Melanoma Patients. It was a Phase 2, completed study that enrolled 20 participants with melanoma in the United States. It was uncontrolled, not randomized, and not double blinded, and it enrolled adults aged 18 years and older.
No. Fecal microbiota transplant with pembrolizumab is investigational and has not been approved by the FDA for melanoma. Its only registered study, NCT03341143, was a completed Phase 2 trial with 20 patients. Further clinical development would be needed before any regulatory approval could be considered.