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 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: GCT1046-072025-520468-16
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

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

Keywords

Melanoma; Cutaneous Melanoma; Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to approximately 12 months

Secondary Outcomes (6)

• Time to Response (TTR)

  Up to approximately 15 months

• Duration of Response (DOR)

  Up to approximately 15 months

• Progression-free Survival (PFS)

  Up to approximately 15 months

• Overall Survival (OS)

  Up to approximately 15 months

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to approximately 15 months

Study Arms (2)

Acasunlimab in Combination with Pembrolizumab

EXPERIMENTAL

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.

Biological: Acasunlimab; Biological: Pembrolizumab

Acasunlimab

EXPERIMENTAL

Participants with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma that progressed on/after prior CPI(s) will receive acasunlimab Q6W.

Biological: Acasunlimab

Interventions

Acasunlimab BIOLOGICAL

Intravenous (IV) infusion

Also known as: GEN1046, DuoBody®-PD-L1×4-1BB

Acasunlimab; Acasunlimab in Combination with Pembrolizumab

Pembrolizumab BIOLOGICAL

IV infusion

Acasunlimab in Combination with Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (2)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Pan American Center for Oncology Trials, LLC

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Melanoma; Recurrence

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); PR (1)