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

Melanoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155322
• Other study ID #: 4031-400
• Status: Completed
• Phase: Phase 2
• Start date: August 19, 2014
• Est. completion date: March 21, 2016

Study information

• Verified date: July 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 21, 2016
• Est. primary completion date: March 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a for any reason

• Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Pegylated Interferon Alfa-2b
6 µg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Adverse Events (AEs)	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.	From first dose through follow-up; up to 13 months
Primary	Percentage of Participants Discontinuing Study Drug Because of AEs	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.	From first dose to last dose of treatment; up to 12 months