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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
  Purpose
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.

Condition Intervention Phase
Malignant Melanoma Biological: PegIFN alfa-2b Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 9
Actual Study Start Date: December 25, 2012
Study Completion Date: November 4, 2015
Primary Completion Date: March 26, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Biological: PegIFN alfa-2b

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

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636960

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01636960     History of Changes
Other Study ID Numbers: P08556
MK-4031-370 ( Other Identifier: Merck protocol number )
132228 ( Registry Identifier: JAPIC-CTI )
Study First Received: July 5, 2012
Results First Received: January 26, 2015
Last Updated: May 19, 2017
Individual Participant Data  
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


Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017