Clinical trial NCT02155322: A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-06-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose through follow-up; up to 13 months
measure: Percentage of Participants Discontinuing Study Drug Because of AEs
timeFrame: From first dose to last dose of treatment; up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: