Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00324155

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 and Dacarbazine Drug: Placebo and Dacarbazine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Drug Information available for: Ipilimumab Dacarbazine

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 ]

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 [ 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 PK [ Time Frame: PK samples are collected at Weeks 1, 7, 7 to 8, 8 to 9, and 10 ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Ipilimumab and Dacarbazine Intravenous solution; ipilimumab - intravenous; dacarbazine - intravenouse, Ipilimumab 10mg/kg; dacarbazine and 850 mg/m2, Ipilimumab - one dose every 3 wks for 10wks then one dose every 12 wks starting at Wk24; dacarbazine one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawl of consent
B: Active Comparator	Drug: Placebo and Dacarbazine Intravenous solution; intravenous; Placebo - 0 mg; dacarbazine - 850 mg/m2, Placebo - one dose every 3 wks for 10 wks then one dose every 12w ks starting at Wk24; dacarbazine - one dose every 3 wks for 22 wks, until disease progression, unacceptable toxicity or withdrawl of consent

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
ECOG 0 or 1
Lab / imaging requirements
Neg for HIV, 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 113 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA184-024
Study First Received:	May 8, 2006
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00324155 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Stage IIIc N3 (unresectable)
Stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Antineoplastic Agents, Alkylating
Nevus
Alkylating Agents
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on September 01, 2009