NeoAdjuvant PD-1–Based Therapy in Resectable Advanced Melanoma (NASA)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial assigns adults with resectable stage IIIB–IVa melanoma to receive neoadjuvant PD-1–based regimens: either two pembrolizumab infusions or one infusion of ipilimumab with nivolumab followed by a single nivolumab dose. Participants are then followed with imaging to measure event-free survival at 12 months and overall survival at 24 months from the first neoadjuvant dose. The aim is to determine if neoadjuvant PD-1–based treatment without subsequent adjuvant therapy is non-inferior for overall survival. Key eligibility includes measurable disease, adequate organ function, and good performance status; prior PD-1/CTLA-4 therapy and certain autoimmune conditions are exclusions. The study is led by UNC Lineberger Comprehensive Cancer Center and conducted at its Chapel Hill site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent will be obtained to participate in the study, and HIPAA authorization for the release of personal health information.
* Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee, including randomization.
* Age ≥ 18 years at the time of consent.
* ECOG Performance Status of 0-2.
* Histological confirmation of cutaneous melanoma or melanoma of unknown primary.
* AJCC stage IIIB/IVa resectable disease that is measurable by iRECIST criteria.
* Adequate hematologic, renal, hepatic, and heart function

Exclusion Criteria:

* Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T-lymphocyte Antigen 4 (CTLA-4).
* Has an active autoimmune disease that requires systemic treatment with the use of disease-modifying agents or immunosuppressive drugs. For corticosteroids, up to 10 mg of prednisone daily, or an equivalent dose, is permitted. Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Any condition, including laboratory abnormalities, that, in the opinion of the investigator, places the subject at unacceptable risk if he/she were to participate in the study. This includes, but is not limited to, serious medical conditions or psychiatric illnesses that are likely to interfere with participation in this clinical study.

Where it's running

• Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Stergios Moschos, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Claire Kowalczyk
• Email: claire_kowalczyk@med.unc.edu
• Phone: 919-984-0000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.