Trial intelligence / Profile preview

Enfortumab Vedotin + Pembrolizumab in Advanced Melanoma

NCT06906822Phase 2

Key facts

Status: Active, not recruiting
Start: Jun 2025
Primary completion: Jun 2027
Countries: 1
Modality: Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules

Drugs: enfortumab vedotin
Conditions: melanoma

Overview

Phase 2, open-label trial of enfortumab vedotin in melanoma (2 cohorts). Primary endpoint: Objective Response Rate up to 2 years. Started Jun 2025; status: active, not recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort 1
Patients without BRAF V600E mutation who progressed on IO therapy receiving EV + pembrolizumab.
Cohort 2
Patients with activating BRAF mutations who progressed on IO therapy and BRAF/MEKi receiving EV + pembrolizumab.

Who it enrols

Adults with unresectable or metastatic melanoma who progressed on prior anti-PD-1/L1 therapy (and BRAF/MEK inhibitors if BRAF mutated), with ECOG 0-1, excluding those with prior EV or MMAE-based ADCs, active CNS metastases, or active autoimmune disease.

Endpoints

Primary

Objective Response Rateup to 2 years

Secondary

Progression-Free Survival12 months
Overall Survival24 months
Clinical Benefit Rateup to 24 months
Duration of Responseup to 12 months
Treatment-Free Survivalup to 24 months
Treatment-Free Intervalup to 24 months
Adverse Eventsup to 24 months
Health-Related Quality of Lifespecified time points

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