Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02112032
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Advanced Melanoma With MK-3475 and Peginterferon
Sponsor:
Hassane M. Zarour, MD
Organization:
Study Overview
Official Title:
Phase 1 Study of Anti-PD-1 Antibody MK-3475 and Peginterferon Alfa-2b for Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to test how safe it is to give the combination of PEG IFN-α2b (SYLATRON) and MK-3475, an investigational drug, to patients with advanced melanoma. Its effectiveness against melanoma will also be evaluated.
Detailed Description:
This is a safety and dose-seeking study of combination MK-3475 and peginterferon alfa-2b for adult patients (≥18) with advanced melanoma. A total of 32 patients will be included. Subjects will undergo screening evaluations to determine eligibility within 28 days (4 weeks) of the first dose. Each 21 day dosing period will constitute a cycle.
Peginterferon alfa-2b is given subcutaneously, weekly according to the regimen below. peginterferon alfa-2b (Sylatron) is FDA-approved for the adjuvant treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
MK-3475 is a potent humanized IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2. MK-3475 has an acceptable preclinical safety profile and is being advanced for clinical development as an immunotherapy for advanced malignancies. In this protocol, MK-3475 is being evaluated at 2 mg/kg intravenously every 3 weeks for 2 years in combination with peginterferon alfa-2b at 1 µg/kg/week, 2 µg/kg/week, or 3 µg/kg/week by subcutaneous injection.
Peginterferon alfa-2b is given subcutaneously, weekly according to the regimen below. peginterferon alfa-2b (Sylatron) is FDA-approved for the adjuvant treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
MK-3475 is a potent humanized IgG4 mAb with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2. MK-3475 has an acceptable preclinical safety profile and is being advanced for clinical development as an immunotherapy for advanced malignancies. In this protocol, MK-3475 is being evaluated at 2 mg/kg intravenously every 3 weeks for 2 years in combination with peginterferon alfa-2b at 1 µg/kg/week, 2 µg/kg/week, or 3 µg/kg/week by subcutaneous injection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: