Safety Study of IL-21/Ipilimumab Combination in the Treatment of Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01489059
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BMS-982470 (recombinant interleukin-21) — BIOLOGICAL
    Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
  • BMS-982470 (recombinant interleukin-21) — BIOLOGICAL
    Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
  • BMS-982470 (recombinant interleukin-21) — BIOLOGICAL
    Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
  • BMS-982470 (recombinant interleukin-21) — BIOLOGICAL
    Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
  • Ipilimumab — BIOLOGICAL
    Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
  • Ipilimumab — BIOLOGICAL
    Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
  • Ipilimumab — BIOLOGICAL
    Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response

Study Details

The purpose of this study is to determine whether the combination of interleukin-21 (IL-21) and Ipilimumab in subjects with melanoma is safe, and provide preliminary information on the clinical benefits of the combination compared with Ipilimumab alone

Key Dates

Start date
Dec 31, 2011
Status verified
Aug 2014
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

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

Arms

  • Experimental: Part 1 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
    Dose Escalation
  • Experimental: Part 1 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
    Dose Escalation
  • Experimental: Part 2 - Arm 1: BMS-982470 (Daily x 5) + Ipilimumab
    Cohort Expansion
  • Experimental: Part 2 - Arm 2: BMS-982470 (Weekly) + Ipilimumab
    Cohort Expansion
  • Active Comparator: Part 2 - Arm 3: Ipilimumab monotherapy
    Cohort Expansion

Primary Outcome Measure

Part1 (Dose Escalation): The Maximum tolerated dose (MTD) of BMS-982470 using 2 distinct schedules when administered in combination with Ipilimumab [ Time Frame: Within the first 63 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Oncology Research Associates, Pllc D/B/AScottsdaleArizona85258-
Ucla Hematology/Oncology.Los AngelesCalifornia90095-
H. Lee Moffitt Cancer Center & Research Inst, IncTampaFlorida33612-
Indiana University Health Melvin And Bren Simon Cancer CenterIndianapolisIndiana46202-
University Of Louisville Medical Center, Inc., DbaLouisvilleKentucky40202-
Portland Providence Medical CenterPortlandOregon97213-
Md Anderson Can CntHoustonTexas77030-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Oncology Research Associates, Pllc D/B/A· Scottsdale, AZUcla Hematology/Oncology.· Los Angeles, CAH. Lee Moffitt Cancer Center & Research Inst, Inc· Tampa, FLIndiana University Health Melvin And Bren Simon Cancer Center· Indianapolis, INUniversity Of Louisville Medical Center, Inc., Dba· Louisville, KYPortland Providence Medical Center· Portland, OR

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