NCT01636960

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2012

Typical duration for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

December 25, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 11, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2015

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

July 5, 2012

Results QC Date

January 26, 2015

Last Update Submit

July 12, 2018

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Safety: Number of Participants Experiencing Adverse Events (AEs)

    From first dose through follow-up; up to 265 Weeks

  • Number of Participants Discontinuing Study Drug Because of AEs

    From first dose to last dose of treatment; up to 260 Weeks

Study Arms (1)

Participants receiving PegIFN alfa-2b

EXPERIMENTAL

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

Interventions

PegIFN alfa-2bBIOLOGICAL
Participants receiving PegIFN alfa-2b

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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: 10.1111/1346-8138.13338.

    PMID: 27087489RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

December 25, 2012

Primary Completion

March 26, 2014

Study Completion

November 4, 2015

Last Updated

August 8, 2018

Results First Posted

February 11, 2015

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Available IPD Datasets

CSR Synopsis Access