Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02823574
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Key Dates

Start date
Nov 8, 2016
Status verified
Apr 2023
Primary completion
Jan 23, 2019
Completion
Apr 21, 2022

Study Design

Enrollment
425 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab
    Specified dose on specified days
  • Active Comparator: Nivolumab and Ipilimumab-placebo
    Specified dose on specified days

Primary Outcome Measure

Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]

Locations (28)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-5024-
Local Institution - 0034DuarteCalifornia91010-
Los Angeles Cancer NetworkLos AngelesCalifornia90017-
Ucla Department Of MedicineLos AngelesCalifornia90095-
Local Institution - 0098Redondo BeachCalifornia90277-
Local Institution - 0004SacramentoCalifornia95816-
Local Institution - 0072San FranciscoCalifornia94158-
Local Institution - 0097San Luis ObispoCalifornia93401-
Central Coast Med OncologySanta MariaCalifornia93454-
Local Institution - 0101New HavenConnecticut06520-
Local Institution - 0007TampaFlorida33612-
Local Institution - 0010AtlantaGeorgia30322-
Local Institution - 0015DecaturGeorgia30033-
Local Institution - 0087ChicagoIllinois60637-
Ft. Wayne Med Onco-Hema IncFort WayneIndiana46845-
Local Institution - 0005LouisvilleKentucky40202-
Oncology Associated Of Western KentuckyPaducahKentucky42003-
Local Institution - 0001BostonMassachusetts02215-
Local Institution - 0071BostonMassachusetts02215-
Local Institution - 0042RochesterMinnesota55905-
Mission Hospital, IncAshevilleNorth Carolina28801-
Local Institution - 0103CincinnatiOhio45219-
Local Institution - 0070ClevelandOhio44106-
Local Institution - 0008PortlandOregon97239-
Local Institution - 0006PittsburghPennsylvania15232-
Donald Guthrie FoundationSayrePennsylvania18840-
Local Institution - 0102DallasTexas75390-
Local Institution - 0038SeattleWashington98109-

Find similar trials in Tucson, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Arizona Cancer Center· Tucson, AZLocal Institution - 0034· Duarte, CALos Angeles Cancer Network· Los Angeles, CAUcla Department Of Medicine· Los Angeles, CALocal Institution - 0098· Redondo Beach, CALocal Institution - 0004· Sacramento, CA

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