Safety and Efficacy Study of BMS-908662 in Combination With Ipilimumab in Subjects With Advanced Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01245556
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BMS-908662 — DRUG
    Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
  • BMS-908662 — DRUG
    Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously
  • Ipilimumab — DRUG
    Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
  • Ipilimumab — DRUG
    Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously

Study Details

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with ipilimumab; and then to evaluate the anti-tumor response to BMS-908662 when administered in combination with ipilimumab.

Key Dates

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

Study Design

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

Arms

  • Experimental: BMS-908662 or Ipilimumab (A)
  • Experimental: BMS-908662 or Ipilimumab (B)

Primary Outcome Measure

Toxicity will be evaluated according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3 [ Time Frame: Assessments approximately every 3 weeks throughout the duration of the trial ]

Locations (2)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Jedd D. Wolchok, Md,PhdNew YorkNew York10065-

Find similar trials in Tampa, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
H. Lee Moffitt Cancer Center & Research Institute· Tampa, FLJedd D. Wolchok, Md,Phd· New York, NY

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