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ACTIVE NOT RECRUITING Phase 2

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BIOLOGICAL Pembrolizumab
  • BIOLOGICAL Acasunlimab

Study Locations (2)

Tennessee

  • Tennessee Oncology, PLLC — Nashville

Other

  • Pan American Center for Oncology Trials, LLC — San Juan

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2025-07-25
Est. Completion 2029-07-15
Phase Phase 2

Sponsor

Genmab

59 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06984328

The ClinicalTrials.gov registry entry for NCT06984328 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Cutaneous Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06984328 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Tennessee, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06984328 about?

NCT06984328 is a clinical study titled "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)". 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. ...

What is the current status of trial NCT06984328?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2025-07-25. Estimated completion is 2029-07-15.

What conditions does trial NCT06984328 study?

This clinical trial studies the following conditions: Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06984328?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Acasunlimab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06984328?

This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06984328 being conducted?

This trial has 2 study locations across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial