drugset / Trial / NCT02339324
Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | — | Intravenous |