Ended Therapeutic exploratory (Phase II) Cutaneous Melanoma, Relapsed/Refractory, Locally Advanced Unresectable Melanoma (Stage IIIB, IIIC, or IIID), Metastatic Cutaneous Melanoma (Stage IV)

Study of the Effectiveness and Safety of Acasunlimab Alone or With Pembrolizumab in treating Advanced Melanoma of the Skin That Has Returned After or did not respond to Cancer Immunotherapy (ABBIL1TY MELANOMA-07)

EU CTIS ID: 2025-520468-16-00

What this study is testing

Evaluate the antitumor activity of acasunlimab as monotherapy and in combination with pembrolizumab.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Subjects ≥ 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.
  • Subject must have radiographic progression 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.
  • Subject must have received a minimum of 2 cycles of an approved anti PD-1 as monotherapy or 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.
  • Subjects with a BRAF V600 mutation should have received prior BRAF-directed therapy (with or without a MEK inhibitor) prior to enrollment in the study, unless deemed not clinically indicated by the Investigator due to concurrent medical condition or prior toxicity.
  • Subject has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 7 days prior to Cycle 1 Day 1.

You likely can't join if

  • Subjects with non-cutaneous or acral melanoma.
  • Subjects with newly identified or known unstable or symptomatic central nervous system metastases or history of carcinomatous meningitis.

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.