Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment 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
NCT02741570
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
  • Ipilimumab — BIOLOGICAL
  • Cetuximab/Erbitux — DRUG
  • Cisplatin/Platinol — DRUG
  • Carboplatin/Paraplatin — DRUG
  • Fluorouracil/Adrucil — DRUG

Study Details

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

Key Dates

Start date
Oct 5, 2016
Status verified
Aug 2023
Primary completion
May 10, 2021
Completion
Sep 22, 2022

Study Design

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

Arms

  • Experimental: Nivolumab and Ipilimumab
    Specified dose on specified days
  • Active Comparator: Extreme Regimen
    Specified dose on specified days

Primary Outcome Measure

Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 [ Time Frame: From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) ]

Locations (22)

FacilityCityStateZIPSite coordinators
Local Institution - 0134TucsonArizona85724-5024-
Local Institution - 0135DuarteCalifornia91010-
Local Institution - 0005StanfordCalifornia94305-
Local Institution - 0028JacksonvilleFlorida32204-
Local Institution - 0008TampaFlorida33612-
Local Institution - 0111AtlantaGeorgia30322-
Local Institution - 0006ChicagoIllinois60637-
Local Institution - 0001BostonMassachusetts02215-
Local Institution - 0080BostonMassachusetts02215-
Local Institution - 0093BostonMassachusetts02215-
Local Institution - 0004Ann ArborMichigan48109-
Local Institution - 0012CharlotteNorth Carolina28204-
Local Institution - 0007ColumbusOhio43210-
Local Institution - 0010LanghornePennsylvania19047-
Local Institution - 0015PhiladelphiaPennsylvania19107-
Local Institution - 0013PittsburghPennsylvania15232-
Local Institution - 0139DallasTexas75390-
Local Institution - 0009HoustonTexas77030-
Local Institution - 0014HoustonTexas77030-
Local Institution - 0003CharlottesvilleVirginia22908-
Local Institution - 0011FairfaxVirginia22301-
Local Institution - 0125MorgantownWest Virginia26506-9162-

Find similar trials in Tucson, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Local Institution - 0134· Tucson, AZLocal Institution - 0135· Duarte, CALocal Institution - 0005· Stanford, CALocal Institution - 0028· Jacksonville, FLLocal Institution - 0008· Tampa, FLLocal Institution - 0111· Atlanta, GA

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