PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01621490
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to evaluate pharmacodynamic changes of Nivolumab and Nivolumab in combination with Ipilimumab treatment on the biomarkers measured in the peripheral blood and tumor tissues of subjects with advanced melanoma (unresectable or advanced)

Key Dates

Start date
Sep 27, 2012
Status verified
Apr 2024
Primary completion
Sep 12, 2017
Completion
Oct 25, 2018

Study Design

Enrollment
170 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1-Cohort 1 and 2: Nivolumab
    Nivolumab 3 mg/kg solution intravenously Every 2 weeks, Up to 2 years depending on response
  • Experimental: Part 2-Arm A: Nivolumab + Ipilimumab
    Nivolumab 1 mg/kg combined with Ipilimumab 3 mg/kg solution intravenously and then Nivolumab 3 mg/kg solution intravenously as specified
  • Experimental: Part 3-Arm A: Nivolumab + Ipilimumab
    Nivolumab 1 mg/kg combined with Ipilimumab 3 mg/kg solution intravenously and then Nivolumab 3 mg/kg solution intravenously as specified
  • Experimental: Part 3-Arm B: Nivolumab
    Nivolumab 3 mg/kg solution intravenously as specified
  • Experimental: Part 4-Arm D: Nivolumab + Ipilimumab
    Nivolumab 1 mg/kg combined with Ipilimumab 3 mg/kg solution intravenously and then Nivolumab 3 mg/kg solution intravenously as specified
  • Experimental: Part 4-Arm E: Nivolumab
    Nivolumab 3 mg/kg solution intravenously as specified

Primary Outcome Measure

Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors [ Time Frame: From last non-missing value prior to first dose to week 7 day 1 ]

Locations (12)

FacilityCityStateZIPSite coordinators
UclaLos AngelesCalifornia90095-
University Of ChicagoChicagoIllinois60637-1443-
Sidney kimmel comprehensive cancer center at johns hopkinsLuthervilleMaryland21093-
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02215-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Providence Portland Medical CenterPortlandOregon97213-
Vanderbilt-Ingram Cancer CtrNashvilleTennessee37232-
The University Of Texas MD Anderson Cancer CenterHoustonTexas77030-
University Of VirginiaCharlottesvilleVirginia22908-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Ucla· Los Angeles, CAUniversity Of Chicago· Chicago, ILSidney kimmel comprehensive cancer center at johns hopkins· Lutherville, MDBeth Israel Deaconess Medical Center (BIDMC)· Boston, MADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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