NCT02339324

Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b

Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b in Patients With Locally/Regionally Advanced/Recurrent Melanoma: Safety, Efficacy and Biomarker Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Yana Najjar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study has 3 main phases: Induction Phase: Pembrolizumab I.V. infusion every 3-4 weeks for 2 doses (starting first week of HDI administration) given concurrently with HDI I.V. x 5 consecutive days out of 7 every week for 4 weeks, followed by S.C. every other day 3 times each week for 2 weeks. This is followed by definitive surgery (week 6-8). Maintenance Phase (following recovery from surgery): Pembrolizumab I.V. infusion every 3 weeks given concurrently with HDI S.C. QOD TIW every week for 46 additional weeks.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab and high dose interferon alfa-2b (HDI)	Pembrolizumab and HDI will be given concurrently during the induction phase of the study for up to 6 weeks from treatment initiation. This is followed by surgery. After recovery from surgery, pembrolizumab and HDI will be reinitiated as maintenance therapy during the maintenance phase of the study.

Timeline

• Start date: 2015-03-06
• Primary completion: 2019-09-01
• Completion: 2019-11-02
• First posted: 2015-01-15
• Last updated: 2021-02-24

Locations

2 sites across 1 country: United States