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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 5, 2026 to Aug 6, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised
  2. Start date: Jul 2026 to Aug 5, 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 pembrolizumab or one infusion of ipilimumab plus nivolumab followed by a single infusion of nivolumab. Patients will undergo follow-up and restaging scans to assess event-free survival at 12 months and OS at 24 months after the first neoadjuvant treatment infusion.
Trial Details
NCT Number NCT07740941
Lead Sponsor UNC Lineberger Comprehensive Cancer Center
Conditions
(from sponsor)		 Melanoma (Skin Cancer), Melanoma Stage Stage IIIB, Melanoma Stage M1, Melanoma Stage IV
Related terms Melanoma
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov