Phase II Study of Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma
University of Utah
Summary
The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy. Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects aged ≥ 18 years. * Histologically confirmed Stage IIIB-D or Stage IV recurrent metastatic melanoma that is resectable or borderline resectable as determined by a Surgical Oncologist. * Recurrent disease at eligibility must have been confirmed with biopsy while receiving or within 3 months of completion of adjuvant anti-PD1 therapy. * ECOG Performance Status ≤ 1. * Adequate organ function as defined as: * Hematologic: * Absolute neutrophil count (ANC) ≥ 1500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 10 g/dL * Hepatic: * Total Biliru…
Interventions
- DrugIpilimumab
Two cycles of neoadjuvant ipilimumab prior to surgical resection.
- DrugNivolumab
two cycles of neoadjuvant nivolumab prior to surgical resection.
Location
- Huntsman Cancer InstituteSalt Lake City, Utah