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Pembrolizumab + Lenvatinib with/without FMT for Melanoma

Phase 2

Waitlist Available

Led By Diwakar Davar, MD, PhD

Research Sponsored by Diwakar Davar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with cutaneous melanoma or unknown primary melanoma may enroll. Patients with uveal or mucosal or acral-lentiginous melanoma are excluded.

Willingness to repeatedly receive FMT administered endoscopically (colonoscopy or sigmoidoscopy) following necessary bowel preparation pre-procedure.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will study how adding microbiome therapy to an existing treatment for PD-1 refractory melanoma affects outcomes over 104 weeks in patients.

Who is the study for?

This trial is for adults with advanced melanoma that has not responded to anti-PD-1 therapy. They must have stable, treated brain metastases if present, agree to use contraception, and be willing to undergo endoscopic FMT. Excluded are those with certain types of melanoma (uveal, mucosal), recent major surgery, severe allergies or gastrointestinal conditions affecting drug absorption, unmanaged side effects from previous treatments, active infections including COVID-19 or hepatitis B/C virus infection.Check my eligibility

What is being tested?

The study tests whether adding Responder-Derived Fecal Microbiota Transplantation (R-FMT) to the combination of Pembrolizumab and Lenvatinib improves outcomes in patients whose melanoma hasn't responded to PD-1 inhibitors. It's a randomized phase II trial over 104 weeks where participants' intestinal microbiome composition is considered as a mediator for their response.See study design

What are the potential side effects?

Potential side effects include immune-related inflammation in various organs due to Pembrolizumab; high blood pressure, fatigue and diarrhea from Lenvatinib; and gastrointestinal discomfort related to R-FMT procedures. Each treatment carries its own risk profile which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have skin melanoma or melanoma of unknown primary, not uveal, mucosal, or acral-lentiginous melanoma.

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I am willing to undergo repeated FMT treatments via endoscopy after preparing my bowels.

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I can provide a new biopsy of my tumor that hasn't been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) per RECIST v1.1

Secondary outcome measures

1-year Overall Survival (OS)

1-year Progression-free Survival (PFS)

2-year Overall Survival (OS)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: R-FMT + pembrolizumab/lenvatinib (Arm A)Experimental Treatment3 Interventions

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 as described). Lenvatinib will be administered at 20 mg daily. R-FMT (induction) will be administered at C1D1 and C4D1 via colonoscopy. R-FMT (maintenance) will be repeated every 9 weeks starting with C4D1 via sigmodoscopy.

Group II: pembrolizumab/lenvatinib (Arm B)Active Control2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Lenvatinib

2005

Completed Phase 4

~2690

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,514 Total Patients Enrolled

Diwakar DavarLead Sponsor

10 Previous Clinical Trials

355 Total Patients Enrolled

8 Trials studying Melanoma

299 Patients Enrolled for Melanoma

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,497 Total Patients Enrolled

120 Trials studying Melanoma

21,627 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the combination of R-FMT with pembrolizumab and lenvatinib currently sanctioned by the FDA?

"The safety of R-FMT + pembrolizumab/lenvatinib (Arm A) was rated a 2 on our scale due to the existent data demonstrating its security, although no proof exists that attests to its efficiency."

Answered by AI

Is this clinical experiment currently recruiting new participants?

"According to information found on clinicaltrials.gov, this trial is no longer actively seeking participants as it was posted and last updated in September of 2023. Nonetheless, there are currently 735 other trials recruiting individuals worldwide at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab/Lenvatinib With and Without Responder-derived FMT in Relapsed/Refractory Melanoma

Diwakar Davar 2024. "Pembrolizumab/Lenvatinib With and Without Responder-derived FMT in Relapsed/Refractory Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06030037.