Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R) Melanoma
Status:
RECRUITING
Trial end date:
2029-12-31
Target enrollment:
Participant gender:
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.
Phase:
PHASE2
Details
Lead Sponsor:
Diwakar Davar
Collaborators:
Gateway for Cancer Research Merck Sharp & Dohme LLC