Melanoma Stage Stage IIIB

1

Review clinical trials related to Melanoma Stage Stage IIIB. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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 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.

Participants needed: 55
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: UNC Lineberger Comprehensive Cancer CenterUpdated: Aug 5, 2026Locations: 1
Eligibility criteria

Written informed consent will be obtained to participate in the study, and HIPAA... [+6]

Prior treatment with PD-1 Programmed cell death Protein 1 (PD-1) and Cytotoxic T... [+2]