Phase 2
Completed N=33
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
Source: ClinicalTrials.gov NCT02155322 ↗Enrolled (actual)
33
Serious AEs
15.6%
Results posted
Apr 2017
Primary outcomePrimary: Percentage of Participants Experiencing Adverse Events (AEs) — 100.0 Percentage of participants
Summary
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Adverse Events (AEs) |
100.0 | — |
| PRIMARY Percentage of Participants Discontinuing Study Drug Because of AEs |
3.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT02155322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.