Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b
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|ClinicalTrials.gov Identifier: NCT02339324|
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Pembrolizumab and high dose interferon alfa-2b (HDI)||Phase 1|
The study has 3 main phases:
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||PI will be leaving this institution and has elected to close this trial to accrual|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Combination Biotherapy With Pembrolizumab and High Dose IFN-alfa2b in Patients With Locally/Regionally Advanced/Recurrent Melanoma: Safety, Efficacy and Biomarker Study|
|Actual Study Start Date :||March 6, 2015|
|Actual Primary Completion Date :||September 1, 2019|
|Actual Study Completion Date :||November 2, 2019|
Experimental: This study has one arm that consists of 3 phases or steps.
Induction phase (first 6 weeks): Pembrolizumab and High Dose IFNα-2b (HDI) Pembrolizumab I.V. every 3-4 weeks for 2 doses concurrently with HDI I.V. x 5 consecutive days every week for 4 weeks, followed by S.C. every other day 3x each week for 2 weeks.
Surgery phase (week 6-8).
Maintenance phase (following recovery from surgery): Pembrolizumab I.V. infusion every 3 weeks given concurrently with HDI S.C. QOD (e.g. M,W,F) TIW every week for 46 additional weeks
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.
Other Name: MK-3475 and Intron A
- The number of participants who experience adverse events. [ Time Frame: Up to 90 days (per patient); Up to 5 years (for cohort) ]
- Evaluate changes in immunologic biomarkers in the blood and in the tumor tissue and assess their association with resposne to treatment. [ Time Frame: Up to 5 years ]
- radiologic preoperative response rate [ Time Frame: Up to 5 years ]
- pathologic response rate [ Time Frame: Up to 5 years ]
- progression free survival [ Time Frame: Up to 5 years ]
- overall survival [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339324
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Pennsylvania|
|Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Yana Najjar, MD||University of Pittsburgh|