A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma - Full Text View

Purpose

The purpose of this clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.

Condition	Intervention	Phase
Melanoma	Drug: ipilimumab (MDX-010, BMS-734016)	Phase II

MedlinePlus related topics:

Melanoma

ChemIDplus related topics:

Ipilimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.

Secondary Outcome Measures:

estimate disease control rate
estimate progression free survival rate at Week 12
estimate PFS
estimate overall survival
estimate survival rate at one year
estimate duration of BOR
evaluate proportion of patients whose duration of response is >=24 weeks
estimate time to BOR
evaluate safety profile of ipilimumab during the induction and maintenance phases
evaluate health-related quality of life
obtain PK sample for population PK analysis

Estimated Enrollment:	150
Study Start Date:	March 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental	Drug: ipilimumab (MDX-010, BMS-734016) IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.

Eligibility

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

Criteria

Inclusion Criteria:

Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289627

Show 64 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Medarex

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA184-008
First Received:	February 9, 2006
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00289627
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Previously treated melanoma

Unresectable Stage III

Stage IV

Study placed in the following topic categories:

Neuroectodermal Tumors

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Bristol-Myers Squibb Medarex
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00289627