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Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b

NCT02339324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-02-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Yana Najjar, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339324 on ClinicalTrials.gov