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

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01681212
First received: September 5, 2012
Last updated: January 23, 2014
Last verified: January 2014
  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:


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: January 2015
Estimated Primary Completion Date: January 2015 (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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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 participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
Japan
Local Institution Recruiting
Fukuoka-Shi, Fukuoka, Japan, 8128582
Contact: Site 0004         
Local Institution Recruiting
Kumamoto-Shi, Kumamoto, Japan, 8608556
Contact: Site 0005         
Local Institution Recruiting
Matsumoto-shi, Nagano, Japan, 3908621
Contact: Site 0006         
Local Institution Recruiting
Sunto-Gun, Shizuoka, Japan, 4118777
Contact: Site 0003         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0001         
Local Institution Recruiting
Chuo-Shi, Yamanashi, Japan, 4093898
Contact: Site 0002         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional 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: January 23, 2014
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 April 14, 2014