Who is sponsoring NCT06030037?

NCT06030037 is sponsored by Diwakar Davar.

What condition does NCT06030037 study?

NCT06030037 studies PD-1 Refractory Advanced Melanoma.

What drugs are being tested in NCT06030037?

Interventions: Healthy Donor Fecal Microbiota Transplantation (hdFMT), Pembrolizumab, Lenvatinib.

What is the status of NCT06030037?

NCT06030037 is currently WITHDRAWN.

Last reviewed 2025-09-29 · How we verify

Pembrolizumab/Lenvatinib With and Without Healthy Donor FMT (hdFMT) in Relapsed/ Refractory (R/R) Melanoma

NCT06030037 PHASE2 WITHDRAWN

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.

Details

Lead sponsor	Diwakar Davar
Phase	PHASE2
Status	WITHDRAWN
Start date	Tue Mar 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Dec 31 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

PD-1 Refractory Advanced Melanoma

Interventions

Healthy Donor Fecal Microbiota Transplantation (hdFMT)
Pembrolizumab
Lenvatinib