Study on the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab for Treating Advanced Skin Melanoma That Has Returned After Previous Treatment

Sponsor: Genmab

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06984328

Provider View

This clinical trial is exploring how well the drug acasunlimab works alone or with pembrolizumab in treating advanced melanoma of the skin that has come back after previous treatment with a checkpoint inhibitor. All participants will receive active treatment, and the study will last about 15 months for each person.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of a new drug called acasunlimab, either by itself or combined with pembrolizumab, in treating advanced melanoma of the skin that has returned after previous treatment. Participants will not receive a placebo; everyone will get active medication. The study will last around 15 months for each participant, including a 28-day screening period, about 4 months of treatment, and 10 months of follow-up. However, the treatment and follow-up periods may vary for each person. Participants will have regular check-ups, starting with weekly visits and then every three weeks later in the trial.

Description

This Phase 2 study is testing the effectiveness and safety of acasunlimab, both alone and with pembrolizumab, in adults with advanced melanoma of the skin that has returned or worsened after previous treatment. Participants will be randomly assigned to receive either acasunlimab with pembrolizumab or acasunlimab alone. To be eligible, participants must have previously received at least two cycles of an approved anti-PD-1 therapy. If the melanoma has a specific BRAF V600 mutation, participants should have had BRAF-targeted therapy before joining the trial, unless the doctor decides it's not necessary due to other health conditions. The BRAF mutation status must be confirmed by local testing.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of advanced melanoma of the skin that cannot be surgically removed or has spread (Stage IIIB, IIIC, IIID, or Stage IV).
  • The cancer must have worsened after at least one previous treatment, including a PD-1 blocking antibody.
  • Must have received at least two cycles of an approved anti-PD-1 therapy.
  • If the cancer has a BRAF V600 mutation, participants should have had BRAF-targeted therapy unless not recommended by the doctor.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Participants with non-skin types of melanoma or melanoma on the palms, soles, or under the nails.
  • Participants with new or unstable cancer spread to the brain or a history of cancer in the brain lining.

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