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

This study has been terminated.
(The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636960
First received: July 5, 2012
Last updated: May 19, 2017
Last verified: May 2017
July 5, 2012
May 19, 2017
December 25, 2012
March 26, 2014   (Final data collection date for primary outcome measure)
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase [ Time Frame: From first dose to end of induction phase; up to 8 Weeks ]
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From first dose through 8 weeks ]
Complete list of historical versions of study NCT01636960 on ClinicalTrials.gov Archive Site
  • Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: From first dose through follow-up; up to 265 Weeks ]
    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.
  • Number of Participants Discontinuing Study Drug Because of AEs [ Time Frame: From first dose to last dose of treatment; up to 260 Weeks ]
    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.
Not Provided
Not Provided
Not Provided
 
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
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)
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.
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malignant Melanoma
Biological: PegIFN alfa-2b
Experimental: Participants receiving PegIFN alfa-2b
Participants receive PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
Intervention: Biological: PegIFN alfa-2b
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: 10.1111/1346-8138.13338.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
November 4, 2015
March 26, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01636960
P08556
MK-4031-370 ( Other Identifier: Merck protocol number )
132228 ( Registry Identifier: JAPIC-CTI )
No
Not Provided
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP