NCT06906822: PlugIN

A Phase II, Open-label, Multicenter, Non-Randomized Study of the Efficacy and Safety of Enfortumab Vetodin in Combination With Pembrolizumab Previously Treated Advanced Melanoma

Recruiting now Phase 2 Last updated 16 September 2025

What this trial tests

Phase 2 trial testing enfortumab vedotin in Melanoma in 60 participants. Currently enrolling.

Timeline

10 June 2025

Primary endpoint
1 June 2027

1 June 2028

Quick facts

Lead sponsor	Grupo Español Multidisciplinar de Melanoma
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	10 June 2025
Primary completion	1 June 2027
Estimated completion	1 June 2028
Sites	13 locations across Spain

Drugs / interventions tested

• enfortumab vedotin — full drug profile →
• pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Grupo Español Multidisciplinar de Melanoma — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Objective response rate (ORR)
  Time frame: Throughout the study period,period, from initiation of treatment up to 2 years
  Objective Response Rate (ORR) as assessed by the investigator through Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). This will be considered as the percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study. Estimates of the ORR along with the associated 95% exact binomial confidence

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.