drugset / Trial / NCT06030037
Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R) Melanoma
Phase 2
Withdrawn
Diwakar Davar
Gateway for Cancer Research · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this is a randomized phase II study the addition of hd-FMT (healthy donor fecal-microbiota transplant) to pembrolizumab /lenvatinib in PD-1 R/R melanoma will be evaluated over a 104-week period in patients with anti-PD-1 R/R disease. Patients with PD-1 refractory advanced melanoma are eligible to enroll, excluding patients with prior lenvatinib (or other TKI) exposure. Intestinal microbiome composition mediates response to anti-PD-1 by affecting systemic inflammatory tone.
Timeline
- Start
- 2025-03-11
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Outcome
Outcome not reported
Stopped: “Trial withdrawn per PI directive”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenvatinib | Small molecule | 20 mg | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
Indications
No indication recorded.