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PLUG-IN: Pembrolizumab Combined With Enfortumab Vedotin for Advanced Melanoma Patients

NCT06906822 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-18

No results posted yet for this study

Summary

There is a lack of strategies for patients who progress after responding to PD-1/l-1 in melanoma. High expression of Nectin4 in skin and melanomas may serve as a new target in advanced melanomas. The combination of enfortumab/vedotin (EV) and pembrolizumab has shown synergistic effect in various solid tumors. Enfortumab vedotin and pembrolizumab may have a dual effect on clinical outcomes.

PLUGIN is a multicenter, non-randomized open-label, 2-cohort, phase 2 study to evaluate the ORR of pembrolizumab in combination with enfortumab vedotin (EV) in previously treated participants with unresectable stage III or IV melanoma and disease progression on standard therapy.

The primary objective is evaluate the efficacy of enfortumab/vedotin and pembrolizumabplus pembrolizumab in advanced melanoma.

Hypothesis: 1) High expression of Nectin4 in skin and melanomas may serve as a new target in advanced melanomas; 2)EV+Pembrolizumab has shown synergistic effect in various solid tumors; 3) There is a lack of strategies for patients who respond to PD1-mAbs in melanoma.

Primary Endpoint: Objective Response Rate (ORR) as assessed by the investigator according RECIST 1.1

A total of 60 patients will be enrolled in this study to evaluate efficacy and outcomes in two different cohorts:

Cohort 1: patients who did not have BRAF mutation V600E and had disease progression on immune (IO) therapy.

Cohort 2, patients with activating BRAF mutations, must have progressed on IO therapy and BRAF/MEKi

Conditions

Interventions

DRUG

enfortumab vedotin

Enfortumab vedotin 1.25 mg/kg be administered on Days 1,8,22 and 29 of every 6-week cycle by IV infusion given over approximately 30 minutes.

DRUG

pembrolizumab

Pembrolizumab 400 mg on day 1 of each 42-day cycle (Q6W)

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Grupo Español Multidisciplinar de Melanoma

    lead OTHER

Principal Investigators

  • Guillermo de Velasco, M.D., Ph.D. · Hospital Universitario 12 de Octubre

  • Ainara Soria, M.D., Ph.D. · Hospital Universitario Ramón y Cajal

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • Spain

Study Locations

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Drugs
Diseases
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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 NCT06906822 on ClinicalTrials.gov