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)

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Genmab
Study ID
NCT06984328
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acasunlimab — BIOLOGICAL
    Intravenous (IV) infusion
  • Pembrolizumab — BIOLOGICAL
    IV infusion

Study Details

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.

Key Dates

Start date
Jul 25, 2025
Status verified
Jun 2026
Primary completion
May 15, 2026
Completion
May 15, 2026

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acasunlimab in Combination with Pembrolizumab
    Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab once every 6 weeks (Q6W) in combination with pembrolizumab Q6W.
  • Experimental: Acasunlimab
    Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Oncology, PLLCNashvilleTennessee37203-

Find similar trials in Nashville, TN

By research site
Tennessee Oncology, PLLC· Nashville, TN

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