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: March 4, 2014
Last verified: March 2014

July 5, 2012
March 4, 2014
December 2012
March 2014   (final data collection date for primary outcome measure)
  • Safety: Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]
  • Tolerability: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Induction (From first dose through 8 weeks) ] [ Designated as safety issue: Yes ]
Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From first dose through 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01636960 on ClinicalTrials.gov Archive Site
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A Study of Pegylated Interferon Alfa-2b as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (P08556)
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.

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Malignant Melanoma
Drug: PegIFN alfa-2b
PegIFN alfa-2b, subcutaneously, on Day 1 of each week at a dose of 3 or 6 μg/kg for 8 weeks (induction) and 3 μg/kg for up to an additional 252 weeks (maintenance).
Experimental: Participants receiving PegIFN alfa-2b
Intervention: Drug: PegIFN alfa-2b
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
October 2016
March 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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01636960
P08556, MK-4031-370, 132228
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

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