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

First listed
Nov 22, 2010
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

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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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