Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00803374
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 30, 2010
Status verified
Nov 2011
Primary completion
Jul 31, 2012
Completion
Jan 31, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.1 mg/kg
  • Experimental: 0.3 mg/kg
  • Experimental: 1.0 mg/kg
  • Experimental: 3.0 mg/kg
  • Experimental: 10 mg/kg

Primary 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 [ 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 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Local InstitutionLos AngelesCalifornia90025-
Local InstitutionNew HavenConnecticut06520-
Local InstitutionTampaFlorida33612-
Local InstitutionBostonMassachusetts02114-
Local InstitutionBostonMassachusetts02115-
Local InstitutionBostonMassachusetts02215-
Local InstitutionNew YorkNew York10021-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Local Institution· Los Angeles, CALocal Institution· New Haven, CTLocal Institution· Tampa, FLLocal Institution· Boston, MALocal Institution· New York, NY

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