Clinical trial · Interventional
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
NCT02155322CI-TRIAL-00034529completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated Interferon Alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-IFN
- description
- 6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12)
- interventionNames
- Biological: Pegylated Interferon Alfa-2b
Primary outcomes (2)
- measure
- Percentage of Participants Experiencing Adverse Events (AEs)
- timeFrame
- From first dose through follow-up; up to 13 months
- description
- 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.
- measure
- Percentage of Participants Discontinuing Study Drug Because of AEs
- timeFrame
- From first dose to last dose of treatment; up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.