NeoAdjuvant, Spare-Adjuvant (NASA) in Stage IIIB- IV (M1a) Melanoma
UNC Lineberger Comprehensive Cancer Center
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). We hypothesize 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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 h…
Interventions
- DrugPembrolizumab
Pembrolizumab 200 mg IV, every 3 weeks
- DrugIpilimumab 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
Location
- Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina