Overview

Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b

Status:
Completed
Trial end date:
2019-11-02
Target enrollment:
Participant gender:
Summary
This study plans to to estimate the safety profile of the combination biotherapy regimen consisting of standard-dose interferon alpha-2b (HDI) and anti-PD1 monoclonal antibody, Pembrolizumab, for the neoadjuvant therapy of locally/regionally advanced/recurrent melanoma. Also, the objectives of this trial include the evaluation of prognostic and predictive biomarkers, radiologic preoperative response rate, pathologic response rate, progression free survival and overall survival. Up to 30 evaluable patients will be accrued.
Phase:
Phase 1
Details
Lead Sponsor:
University of Pittsburgh
Yana Najjar
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Interferon alpha-2
Interferon-alpha
Interferons
Pembrolizumab