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Cutaneous MelanomaPhase 2NCT06984328

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)

A Phase 2 study testing Acasunlimab and Pembrolizumab in people with Cutaneous Melanoma and Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), run by Genmab at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acasunlimab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesin 2 countries
Study dates
25 Jul 2025to 15 May 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants ≥ 18 years of age with histologically or cytologically confirmed diagnosis of relapsed/refractory, locally advanced unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, per American Joint Committee on Cancer (8th edition) staging.
  • Participant must have radiographic progression based on RECIST v1.1 on or following ≥ 1 prior systemic therapy, according to local and international guidelines, including a programmed cell death protein 1 blocking antibody (anti-PD-1) treatment or combination treatment containing an anti-PD-1.
  • Participant must have received a minimum of 2 cycles of an approved anti-PD-1 as monotherapy or a combination therapy containing an anti-PD-1.
  • Neoadjuvant and/or adjuvant systemic therapy count as the first line of prior systemic therapy if there is documented disease progression ≤ 6 months after completion of therapy.
  • Participants with a BRAF V600 mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the trial, unless deemed not clinically indicated by the Investigator due to concurrent medical condition or prior toxicity.
  • Participant has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days prior to Cycle 1 Day 1.

Who cannot join

  • Participants with non-cutaneous or acral melanoma.
  • Participants with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.
  • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

Other trials in United States

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC

    San Juan, Puerto Rico, 00909

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Read the 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.

Being tested
Acasunlimab, Pembrolizumab
Keywords
Melanoma, Cutaneous Melanoma, Metastatic Melanoma
Medical subject headings
Melanoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcasunlimabBiological

    Also called GEN1046, DuoBody®-PD-L1×4-1BB

    Intravenous (IV) infusion

  • PembrolizumabBiological

    IV infusion

Study groups in NCT06984328
Study groupRoleWhat they receive
Acasunlimab in Combination with PembrolizumabExperimentalParticipants 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.
Receives: Biological: Acasunlimab; Biological: Pembrolizumab
AcasunlimabExperimentalParticipants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.
Receives: Biological: Acasunlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with a confirmed response of complete response (CR) or partial response (PR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to approximately 9 months

Secondary outcomes (6)

  1. Time to Response (TTR)

    TTR per RECIST v1.1 as assessed by the investigator was defined as the time from the date of first administration of trial drug to the first documented response of either CR or PR.

    Measured: Up to approximately 9 months

  2. Duration of Response (DOR)

    DOR per RECIST v1.1 as assessed by the investigator was defined as the time from first documentation of objective response (PR or CR) that was subsequently confirmed, to the first documentation of disease progression or death due to any cause, whichever came first.

    Measured: Up to approximately 9 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from the date of first administration of trial drug to the date of the first documented progression or death due to any cause, whichever occurred first.

    Measured: Up to approximately 9 months

  4. Overall Survival (OS)

    OS was defined as the time from date of first administration of trial drug to date of death due to any cause.

    Measured: Up to approximately 9 months

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical trial participant, associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE was any AE that started after or worsened after drug administration.

    Measured: Up to approximately 9 months

  6. Time to Treatment Discontinuation Due to AEs

    Measured: Up to approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2025
  2. Study start25 Jul 2025
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Why it stopped: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06984328
Sponsor's protocol ID
GCT1046-07
Other IDs
2025-520468-16, 2025
Status last verified
Sep 2026
First submitted
14 May 2025
Last updated
30 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acasunlimab and Pembrolizumab in people with Cutaneous Melanoma and Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), run by Genmab at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06984328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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