Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01629758
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasms by Site

Eligibility Criteria

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

Interventions

  • Denenicokin — BIOLOGICAL
  • Nivolumab — BIOLOGICAL

Study Details

The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.

Key Dates

Start date
Jun 30, 2012
Status verified
Feb 2015
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Part 1-Arm A: BMS-982470 (weekly x 4) + BMS-936558
    Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
  • Experimental: Part 1-Arm B: BMS-982470 (3 times/week) + BMS-936558
    Dose Escalation BMS-982470 10, 30, 50, 75 or 100 µg/kg Solution, Intravenous, During each 6 week cycle: 3 times/week during weeks 1 and 3, Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years
  • Experimental: Part 2-Arm A: BMS-982470 (weekly x 4) + BMS-936558
    Cohort Expansion BMS-982470 (dose selected in Part 1) Solution, Intravenous, During each 6 week cycle: weekly x 4 (i.e during weeks 1 through 4), Up to 2 years + BMS-936558 3 mg/kg Solution, Intravenous, During each 6 week cycle: every other week (i.e during weeks 1, 3, and 5), Up to 2 years

Primary Outcome Measure

Safety, as measured by the rate of adverse events and serious adverse events [ Time Frame: Approximately up to 4.5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Oncology Research Associates, Pllc D/B/AScottsdaleArizona85258-
Yale University School Of MedicineNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-
Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimoreMaryland21231-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Scottsdale, AZ

By research site
Oncology Research Associates, Pllc D/B/A· Scottsdale, AZYale University School Of Medicine· New Haven, CTMoffitt Cancer Center· Tampa, FLSidney Kimmel Comprehensive Cancer Center At Johns Hopkins· Baltimore, MDSeattle Cancer Care Alliance· Seattle, WA

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