Efficacy and Safety Study of Acasunlimab as Monotherapy and in Combination With Pembrolizumab in Subjects With Relapsed/Refractory, Unresectable Locally Advanced or Metastatic Cutaneous Melanoma That Progressed On or After Treatment With a Checkpoint Inhibitor

2025-520468-16-00 · tracked via the Priya Life Science EU tracker

Sponsor

Genmab A/S

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

23/10/2025

Enrollment target

129

Sites

France, Spain, Netherlands, Germany

Condition studied

Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV)

Investigational medicinal product(s)

AcasunlimabKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Age group

65+ years, 18-64 years

Sex

Female, Male

Primary endpoint

Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-520468-16-00 on CTIS ↗ ← All trials in the EU