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A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)

NCT02155322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-08-23

Study results available
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Summary

This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.

Conditions

Interventions

BIOLOGICAL

Pegylated Interferon Alfa-2b

6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks

BIOLOGICAL

Pegylated Interferon Alfa-2b

3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2016-03-21
Completion
2016-03-21

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Diseases
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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 NCT02155322 on ClinicalTrials.gov