Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07740941
PHASE2

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

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2026-08-05

Completion Date

2029-03

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV, every 3 weeks

DRUG

Ipilimumab plus nivolumab

Single infusion of concurrent ipilimumab (3 mg/kg) plus nivolumab (1 mg/kg) followed by a single infusion of nivolumab 240 mg IV 3 weeks later

Locations (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States