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Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medarex
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00324155
First received: May 8, 2006
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this clinical research study is to examine the safety and effectiveness (how well the drug works) of two different treatments for patients with melanoma. One treatment is an investigational compound (a drug that is not currently approved by the United States Food and Drug Administration [FDA]), know as Ipilimumab (also known as MDX-010 or BMS-734016) together with an approved chemotherapy drug called Dacarbazine


Condition Intervention Phase
Melanoma
 Drug: Ipilimumab
Drug: Placebo
Drug: Dacarbazine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-Blind, Two-Arm, Phase III Study in Patients With Untreated Stage III (Unresectable) or IV Melanoma Receiving Dacarbazine Plus 10 mg/kg Ipilimumab (MDX-010) vs. Dacarbazine With Placebo

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:
  • Overall Survival [ Time Frame: Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: No ]
  • Extension phase: Survival rates at 3, 4 and 5 years [ Time Frame: Patient Status is assessed at every visit (every 12 weeks in the Extended Dosing Phase and every 24 weeks in the Extended Follow-Up Phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
  • Best Overall Response Rate [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
  • Survival rate at one year, eighteen months, and two years [ Time Frame: Patient Status is assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: Tumor Assessments at Baseline Visit in the Screening Phase, Wks 12, 16, 20, & 24 in Induction Phase, Wks 30, 36, 42, 48, & every 12 wks thereafter in Maintenance Phase, & the first two standard- of-care scans are collected in Follow-up Phase ] [ Designated as safety issue: No ]
  • Safety Profile [ Time Frame: Adverse Events are assessed at every visit (Weeks 1, 4, 7, 10, 12, 13, 16, 19, 20, 22, 24 in the Induction Phase, Weeks 24, 30, 36, 42, 48 and every 12 weeks thereafter in the Maintenance Phase, and every 12 weeks in the Follow-up Phase) ] [ Designated as safety issue: Yes ]
  • Health-Related Quality of Life (QoL) [ Time Frame: QoL assessments are performed at Weeks 1, 4, 7, 12, 24, 36, 48, and at the first follow-up phase visit ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) [ Time Frame: PK samples are collected at Weeks 1, 7, 7 to 8, 8 to 9, and 10 ] [ Designated as safety issue: No ]
  • Extension phase: Safety profile of Ipilimumab for patients in the Extension Phase [ Time Frame: Safety will be assessed every 12 weeks in the Extended Dosing Phase and every 24 weeks in the Extended Follow-Up Phase ] [ Designated as safety issue: No ]
    Incidence of adverse events and their severity


Estimated Enrollment: 500
Study Start Date: August 2006
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Ipilimumab and Dacarbazine
In Extension phase: Ipilimumab will be continued. Dacarbazine was given up to Week 22 and is not given in the Extension phase
 Drug: Ipilimumab

Intravenous solution; intravenous; 10mg/kg; one dose every 3 wks for 10wks then one dose every 12 wks starting at Wk24, until disease progression, unacceptable toxicity or withdrawal of consent

In Extension phase: Only Ipilimumab: 10mg/kg, every 12 wks will be continued until disease progression

Other Names:
  • MDX-010
  • BMS-734016
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m2; one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawal of consent
Active Comparator: Arm B: Placebo and Dacarbazine Drug: Placebo
Intravenous solution; intravenous; 0 mg; one dose every 3 wks for 10 wks then one dose every 12w ks starting at Wk24; until disease progression, unacceptable toxicity or withdrawal of consent
Drug: Dacarbazine
Intravenous solution; intravenous; 850 mg/m2; one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawal of consent

Detailed Description:

For the extension phase:

Allocation: single arm study; Masking: open label; Intervention Model: Single Group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed Consent
  • Measurable Disease
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Lab / imaging requirements
  • Neg for Human Immunodeficiency Virus (HIV), Hepatitis B (HepB), C
  • Men and Women > 18 years (16 were allowable)
  • Prior therapy restriction (adjuvant only)

Exclusion:

  • Pregnant / nursing
  • Inadequate contraception
  • Brain metastasis
  • Primary ocular or mucosal melanoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324155

  Show 143 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Medarex
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00324155     History of Changes
Other Study ID Numbers: CA184-024
Study First Received: May 8, 2006
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Stage IIIc N3 (unresectable)
Stage IV melanoma

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 June 17, 2013