A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01636960
First received: July 5, 2012
Last updated: February 12, 2015
Last verified: February 2015
  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.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    A DLT is an event (clinical or laboratory) that results in a change in the given dose.


Secondary Outcome Measures:
  • Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 1 year (to be updated as data collection continues) ] [ Designated as safety issue: Yes ]
    An adverse event is 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: Up to 1 year (to be updated as data collection continues) ] [ Designated as safety issue: Yes ]
    An adverse event is 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
Study Start Date: December 2012
Estimated Study Completion Date: October 2016
Primary Completion Date: March 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 is ongoing in Maintenance Phase which is planned to continue for up to 252 weeks after study start.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01636960     History of Changes
Other Study ID Numbers: P08556, MK-4031-370, 132228
Study First Received: July 5, 2012
Results First Received: January 26, 2015
Last Updated: February 12, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 03, 2015