A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162123

Purpose

The purpose of this study is to evaluate the continued use of ipilimumab in patients who had clinical benefit in a prior/parent study and are now eligible to receive either Re-Induction at the time of disease progression or to continue Maintenance treatment. In addition, this study will also continue to follow patients that have had ipilimumab but who are not eligible for Maintenance or Re-Induction therapy.

Condition	Intervention	Phase
Melanoma	Drug: Ipilimumab	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To monitor safety of ipilimumab by evaluating the frequency of adverse events and laboratory abnormalities with corresponding severity. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Estimate overall survival from the first dose [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Estimate survival rate from the first dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Monitor Immune Breakthrough Events [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	207
Study Start Date:	May 2006
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Ipilimumab Intravenous Solution, Intravenous, 3 or 10 mg/kg, One dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent Other Names: BMS-734016 MDX-010
Experimental: B	Drug: Ipilimumab Intravenous Solution, Intravenous, 0.3, 3 or 10 mg/kg, One Dose every 3 weeks or every 3 months, until patient discontinuation from any study Phase or withdrawal of consent or no intervention Other Names: BMS-734016 MDX-010
No Intervention: C Until withdrawal of consent or study closure

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of advanced melanoma
Prior treatment in a prior/parent ipilimumab study
Men and women >=18 years of age (or, >=16, if allowable per local regulatory authority)

Exclusion Criteria:

Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist, except for ipilimumab
Primary ocular or mucosal melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162123

Show 77 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00162123 History of Changes
Other Study ID Numbers:	CA184-025
Study First Received:	September 9, 2005
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

ipilimumab
previously treated

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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012