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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01681212
First received: September 5, 2012
Last updated: July 9, 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)


Enrollment: 15
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
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: NCT01681212

Locations
Japan
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8128582
Local Institution
Kumamoto-shi, Kumamoto, Japan, 8608556
Local Institution
Matsumoto-shi, Nagano, Japan, 3908621
Local Institution
Sunto-gun, Shizuoka, Japan, 4118777
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Local Institution
Chuo-shi, Yamanashi, Japan, 4093898
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: July 9, 2014
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

ClinicalTrials.gov processed this record on October 21, 2014