NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB-IV (M1a) Melanoma

This study evaluates the impact of neoadjuvant Programmed cell death Protein 1 (PD-1)-based treatment regimens in patients with resectable stage IIIB-M1a cutaneous or unknown primary melanoma at high risk of relapse without adjuvant therapy after definitive lymphadenectomy and irrespective of pathologic response outcome on the 2-year overall survival (OS). It was hypothesized that neoadjuvant PD1 inhibitor-based treatment without adjuvant treatment does not significantly (non-inferior) impact OS in this study patient population. Patients will be randomized to either two infusions of pembrolizu

Trial Details

NCT ID
NCT07740941
Phase
PHASE2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Pembrolizumab
  • Ipilimumab plus nivolumab
Locations (sample)
  • Chapel Hill, North Carolina, United States|35.9132,-79.05584

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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