drugset / Trial / NCT06984328

Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin That Has Returned After Treatment With an Approved Checkpoint Inhibitor Therapy (ABBIL1TY MELANOMA-07)

NCT06984328

Phase 2 Terminated 1 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn about the effectiveness and safety of the bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either alone or together with the cancer drug pembrolizumab in participants with locally advanced or metastatic melanoma of the skin. All participants will receive active drugs; no one will be given a placebo. The trial duration will be approximately 15 months for each participant, including a 28-day screening period and estimated 4-month treatment and 10-month follow-up periods; however, the duration of the treatment and follow-up periods may vary for each participant. Participants will have regular check-ups while on treatment, with visits every week initially, and then every 3 weeks later in the trial.

Timeline

Start
2025-07-25
Primary completion
2026-05-15
Completion
2026-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Acasunlimab Monoclonal antibody Intravenous
Subject Pembrolizumab Monoclonal antibody Intravenous