Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00803374
• Other study ID #: CA186-007
• Status: Withdrawn
• Phase: Phase 1
• First received: December 4, 2008
• Last updated: November 18, 2011
• Start date: November 2010
• Est. completion date: January 2013

Study information

• Verified date: November 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Boston	Massachusetts
United States	Local Institution	Los Angeles	California
United States	Local Institution	New Haven	Connecticut
United States	Local Institution	New York	New York
United States	Local Institution	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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	Yes
Secondary	Evidence of clinical improvement in tumor burden confirmed by CT or MRI		Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter	No

External Links

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