A Phase II Study of Pegylated Interfero… | Clinical Trial

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Competent to self-administer the subcutaneous injections of PEG-IFN
Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations

Exclusion criteria

Mucous membrane melanoma or ocular melanoma
Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
Evidence of distant or non-regional lymph node metastases or in-transit metastases
Disease that cannot be completely surgically resected
Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
Hepatic decompensation
Thyroid dysfunction not responsive to therapy
Uncontrolled diabetes mellitus
Clinically active autoimmune disease
Clinically active and/or uncontrolled infection, including active hepatitis
Human immunodeficiency virus (HIV)
History of neuropsychiatric disorder requiring hospitalization
Actively abusing alcohol or drugs
Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
Medical condition requiring chronic systemic corticosteroids
Received any experimental therapy within 30 days prior to enrolling in this study
Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
Previously received interferon-α for any reason
Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b

Treatment and study plan

Pegylated interferon alfa-2b

Biological

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

Primary outcomes

Percentage of Participants Experiencing Adverse Events (AEs)

Time frame: From first dose through follow-up; up to 13 months

An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Percentage of Participants Discontinuing Study Drug Because of AEs

Time frame: From first dose to last dose of treatment; up to 12 months

An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 4, 2014
Registry last updated: Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed