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 therapy being studied for the treatment of melanoma. It combines a fecal microbiota transplant with the checkpoint inhibitor pembrolizumab. The therapy is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Fecal Microbiota Transplant with Pembrolizumab is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this combination therapy for melanoma, and it is currently in Phase 2 development.
Fecal Microbiota Transplant with Pembrolizumab is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA or other regulatory agencies. The therapy is being studied for the treatment of melanoma, and its clinical trial has been completed.
Fecal Microbiota Transplant with Pembrolizumab has one completed clinical trial, identified as NCT03341143, titled "Fecal Microbiota Transplant (FMT) in Melanoma Patients." This Phase 2 study enrolled 20 participants with melanoma in the United States. The trial was uncontrolled, meaning there was no comparator arm.
Yes, Fecal Microbiota Transplant with Pembrolizumab is commonly referred to as FMT with pembrolizumab. The therapy combines a fecal microbiota transplant with the immune checkpoint inhibitor pembrolizumab. It is being investigated as a potential treatment for melanoma in a Phase 2 clinical trial.