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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)

StatusTerminated
PhasePhase 2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗
Why the trial stopped
Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.

Record History

  1. Results posted: Sep 30, 2026 Sponsor's reason: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision… to Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision… · Eligibility criteria expanded, about 8 words · Secondary endpoints revised (6) · 2 more Show 5 more changesShow less
    • Sponsor's reason: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision… to Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision…
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (6)
    • Study description revised
    • Site details revised at 1 of 2 sites
  2. Site details revised at 1 of 2 sitesv18
  3. Trial terminated Sponsor's reason: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision… Primary completion moved earlier from Jul 15, 2027 to May 15, 2026 · Completion moved earlier from Jul 15, 2029 to May 15, 2026 · Site details revised at 1 of 2 sitesv17 Show 3 more changesShow less
    • Primary completion moved earlier from Jul 15, 2027 to May 15, 2026
    • Completion moved earlier from Jul 15, 2029 to May 15, 2026
    • Site details revised at 1 of 2 sites
  4. 5 versions Re-verified since Feb 2, 2026, no change to tracked fieldsv12-v16
  5. Enrollment target: estimated 90 to confirmed 1v11
Show 9 earlier versionsHide 9 earlier versions
  1. 3 versions Re-verified since Nov 3, 2025, no change to tracked fieldsv8-v10
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv7 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 1 to 2v5
  5. Start date changed from estimate of Jul 2025 to Jul 25, 2025 Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Jun 30, 2025 to Jul 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Jun 30, 2025 to Jul 2025
  7. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Genmab
45 trials monitored
See 3 trials at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
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.
Trial Details
NCT Number NCT06984328
Lead Sponsor Genmab
Conditions Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV)
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov