A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)

Malignant Melanoma Clinical Trial

Official title:

An Open-Label, Single-arm, Multicenter Phase I Study of SCH 54031 (Pegylated Interferon Alfa-2b) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (Protocol No. MK-4031 370 Also Known as SCH 54031, P08556)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01636960
• Other study ID #: P08556
• Secondary ID: MK-4031-37013222
• Status: Terminated
• Phase: Phase 1
• Start date: December 25, 2012
• Est. completion date: November 4, 2015

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 is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.

Description:

The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 4, 2015
• Est. primary completion date: March 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Stage II or III melanoma

• Primary melanoma completely excised

• Full lymphadenectomy within 84 days prior to initiation of study treatment

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

• Ocular melanoma or melanoma of the mucous membranes

• Evidence of distant or non-regional lymph node metastases

• In-transit melanoma

• Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Biological:
• PegIFN alfa-2b

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Yamazaki N, Uhara H, Wada H, Matsuda K, Yamamoto K, Shimamoto T, Kiyohara Y. Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma. J Dermatol. 2016 Oct;43(10):1146-1153. doi: 10.1111/1346-8138. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase	A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.	From first dose to end of induction phase; up to 8 Weeks
Secondary	Safety: Number 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 265 Weeks
Secondary	Number 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 260 Weeks