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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA186-007

NCT ID:

NCT00803374

Start Date:

November 2010

Completion Date:

January 2013

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location
Local Institution Bronx, New York  
Local Institution Corona, California  
Local Institution Hamden, Connecticut  
Local Institution Fort Lauderdale, Florida  
Local Institution Springfield, Massachusetts