Study on Neoadjuvant Treatment for Stage IIIB-IV Melanoma

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40

ClinicalTrials ID:NCT07740941

Provider View

This clinical trial is testing whether a new treatment approach using PD-1 inhibitors before surgery can help patients with stage IIIB-IV melanoma avoid additional therapy after surgery, without affecting their overall survival.

Patient Parameters

Program Overview

The study is exploring if using PD-1 inhibitor treatments before surgery can help patients with stage IIIB-IV melanoma avoid further treatment after surgery, without impacting their survival over two years. Patients will be randomly assigned to receive either two doses of pembrolizumab or a combination of ipilimumab and nivolumab followed by one dose of nivolumab. The study will monitor patients' survival without events at 12 months and overall survival at 24 months after starting the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate and allow access to personal health information.
  • Willing and able to follow study procedures, including randomization.
  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have a confirmed diagnosis of cutaneous melanoma or melanoma with an unknown primary source.
  • Have stage IIIB/IVa melanoma that can be surgically removed and is measurable by specific criteria.
  • Have adequate blood, kidney, liver, and heart function.

Exclusion Criteria

  • Have previously received PD-1 or CTLA-4 treatments.
  • Have an active autoimmune disease requiring systemic treatment, except for low-dose corticosteroids or hormone replacement therapy.
  • Have any condition or lab result that the study doctor believes would put the patient at risk if they participate, including serious medical or psychiatric conditions.

Locations

FACILITYZIPCITYSTATE
Lineberger Comprehensive Cancer Center27599Chapel HillNorth Carolina

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