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

NCT06030037 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • PD-1 Refractory Advanced Melanoma

Interventions

BIOLOGICAL

Healthy Donor Fecal Microbiota Transplantation (hdFMT)

hdFMT (induction) via colonoscopy or oral capsule on C1D1 and C3D1. hdFMT (maintenance) via sigmoidoscopy or oral capsules will be repeated every 9 weeks.

DRUG

Pembrolizumab

Pembrolizumab will be administered at 200 mg every 3 weeks (Q3W) as a 30-minute IV infusion (treatment intervals may be increased due to toxicity)

DRUG

Lenvatinib

Lenvatinib will be administered at 20 mg daily

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • Diwakar Davar

    lead OTHER

Principal Investigators

  • Diwakar Davar, MD, PhD · UPMC Hillman Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030037 on ClinicalTrials.gov