drugset
drugset / Trial / NCT06284590

Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients

NCT06284590 ↗

Phase 2 Recruiting 162 enrolled Philogen S.p.A. Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma.

Timeline

Start
2024-07-12
Primary completion
2028-07
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Darleukin Protein / enzyme biologic 1.3e+07 iu Other
Subject Onfekafusp alfa Protein / enzyme biologic 400 ug Other
Background Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications

metastatic melanoma