drugset / Trial / NCT02339324

Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b

NCT02339324

Phase 1 Completed 31 enrolled Yana Najjar Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-03-06
Primary completion
2019-09-01
Completion
2019-11-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject interferon alfa-2b Protein / enzyme biologic Intravenous

Indications