Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00803374

Purpose

The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable

Condition	Intervention	Phase
Melanoma	Drug: AntiCD137 Drug: Ipilimumab	Phase I

MedlinePlus related topics: Melanoma

Drug Information available for: Ipilimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests [ Time Frame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evidence of clinical improvement in tumor burden confirmed by CT or MRI [ Time Frame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
0.1 mg/kg: Experimental	Drug: AntiCD137 Infusion, IV, 0.1 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response Drug: Ipilimumab Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
0.3 mg/kg: Experimental	Drug: AntiCD137 Infusion, IV, 0.3 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response Drug: Ipilimumab Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
1.0 mg/kg: Experimental	Drug: AntiCD137 Infusion, IV, 1.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response Drug: Ipilimumab Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
3.0 mg/kg: Experimental	Drug: AntiCD137 Infusion, IV, 3.0 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response Drug: Ipilimumab Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ weeks depending on response
10 mg/kg: Experimental	Drug: AntiCD137 Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12 weeks, 12+ weeks depending on response Drug: Ipilimumab Infusion, IV, 10 mg/kg, Q3 weeks for 12 weeks then Q12, 12+ 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:

Histologically or cytologically confirmed malignant melanoma
Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

Active/symptomatic brain metastases
Primary ocular melanoma or primary tumor of unknown origin
Concurrent autoimmune disease
Previous treatment with a CD137 agonist or CTLA-4 inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803374

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, California
Local Institution
Los Angeles, California, United States, 90025
United States, Connecticut
Local Institution
New Haven, Connecticut, United States, 06520
United States, Florida
Local Institution
Tampa, Florida, United States, 33612
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02115
Local Institution
Boston, Massachusetts, United States, 02215
Local Institution
Boston, Massachusetts, United States, 02114
United States, New York
Local Institution
New York, New York, United States, 10021

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

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:	CA186-007
Study First Received:	December 4, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00803374 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

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

Nevus
Cytotoxic T-lymphocyte antigen 4
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on May 07, 2009