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Phase 2 Study of Ipilimumab Plus DTIC in Japanese Advanced Melanoma Patients

This study is currently recruiting participants.
Verified October 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01681212
First received: September 5, 2012
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine survival rate at 1 year of Ipilimumab plus Dacarbazine (DTIC) in patients with previously untreated Stage III with N3 (unresectable) or Stage IV melanoma


Condition Intervention Phase
Melanoma
 Biological: Ipilimumab
Drug: Dacarbazine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Survival rate defined as the proportion of subjects who are alive after at least one year of follow up following the first dose of study therapy [ Time Frame: At 1 year after start of study drugs treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of Grade 3-4 Immune-related Adverse Events (irAEs) [ Time Frame: Up to 90 days following the last dose of Ipilimumab ] [ Designated as safety issue: Yes ]
    irAEs will be measured every 3 weeks in induction phase, every 6 weeks in maintenance to Week 48, and every 12 weeks to Progressive Disease (PD)


Estimated Enrollment: 26
Study Start Date: October 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab + Dacarbazine

Ipilimumab 10 mg/kg injection and Dacarbazine 850 mg/m2 injection by Intravenous.

  • Ipilimumab: Every 3 weeks up to 4 doses on Induction Phase (24 weeks), and every 12 weeks on Maintenance Phase until PD or intolerable toxicity
  • Dacarbazine: Every 3 weeks up to 8 doses on Induction Phase (24 Weeks)
 Biological: Ipilimumab
Other Name: BMS-734016
Drug: Dacarbazine

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of malignant melanoma
  • Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma
  • Life expectancy of at least 16 weeks in this study
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Evidence of brain metastases on brain imaging
  • Primary ocular or mucosal melanoma
  • History of or current active autoimmune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681212

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
Japan
Local Institution Not yet recruiting
Fukuoka-city, Fukuoka, Japan, 812-8582
Contact: Site 0004            
Local Institution Not yet recruiting
Kumamoto-city, Kumamoto, Japan, 860-8556
Contact: Site 0005            
Local Institution Not yet recruiting
Matsumoto-city, Nagano, Japan, 390-8621
Contact: Site 0005            
Local Institution Not yet recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Contact: Site 0003            
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Contact: Site 0001            
Local Institution Not yet recruiting
Chuo-city, Yamanashi, Japan, 409-3898
Contact: Site 0002            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01681212     History of Changes
Other Study ID Numbers: CA184-202
Study First Received: September 5, 2012
Last Updated: October 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
 Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013