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)

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 (ABBIL1TY MELANOMA-07)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, randomized, open-label, multicenter trial evaluating the efficacy and safety of acasunlimab as monotherapy and in combination with pembrolizumab in adult participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma who progressed on or after prior checkpoint inhibitor (CPI)-containing therapy. Participants will be randomized in a 1:1 ratio to receive acasunlimab and pembrolizumab or acasunlimab alone. Eligible participants must have received a minimum of 2 cycles of an approved anti-programmed cell death protein 1 (PD-1) containing therapy. Participants whose tumor harbors a B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600 mutation are eligible for the trial if they have received a BRAF-directed therapy (with or without a mitogen-activated protein kinase \[MEK\] inhibitor) prior to enrollment in the trial, unless the investigator has deemed a BRAF-directed therapy not clinically indicated. BRAF V600 mutational status must be determined by local assessment and documented.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Acasunlimab	Intravenous (IV) infusion
BIOLOGICAL	Pembrolizumab	IV infusion

Timeline

• Start date: 2025-07-25
• Primary completion: 2027-07-15
• Completion: 2029-07-15
• First posted: 2025-05-22
• Last updated: 2026-04-08

Locations

2 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study