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)

Launched by GENMAB · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial, called ABBIL1TY MELANOMA-07, is exploring the effectiveness and safety of a new treatment for advanced skin melanoma that has returned after previous therapy. The study is testing a drug called acasunlimab, both on its own and in combination with another medication called pembrolizumab. All participants will receive active treatment; no placebos will be given. The trial will last about 15 months for each participant, which includes a month of screening, followed by approximately four months of treatment and ten months of follow-up care.

To join the trial, participants must be at least 18 years old and have been diagnosed with specific advanced types of melanoma that have not responded to earlier treatments. They should have experienced disease progression after at least one prior therapy, particularly one that includes a type of treatment aimed at boosting the immune system. Throughout the trial, participants will have regular check-ups, starting weekly and then moving to every three weeks. This study is not yet recruiting, but it aims to provide valuable information on how these treatments can help patients with challenging cases of melanoma.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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.
• Key Exclusion Criteria:
• • 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.