Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

Part of paid clinical trials in Stanford, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02105636
Phase
PHASE3
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
  • Cetuximab — DRUG
  • Methotrexate — DRUG
  • Docetaxel — DRUG

Study Details

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

Key Dates

Start date
May 29, 2014
Status verified
Aug 2022
Primary completion
Nov 6, 2015
Completion
Sep 10, 2021

Study Design

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

Arms

  • Experimental: Arm A: Nivolumab
    Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
  • Active Comparator: Arm B: Cetuximab/Methotrexate/Docetaxel
    Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression OR Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression OR Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of randomization to date of death (Up to approximately 18 months) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-
H. Lee Moffitt Cancer CenterTampaFlorida33612-
Local Institution - 0001AtlantaGeorgia30322-
Local Institution - 0002ChicagoIllinois60637-
Local Institution - 0004MetairieLouisiana70006-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University Of MichiganAnn ArborMichigan48109-
DumcDurhamNorth Carolina27710-
Local Institution - 0012ColumbusOhio43210-
Local Institution - 0007PittsburghPennsylvania15213-
Vanderbilt Cancer ClinicNashvilleTennessee37232-
Univ Of Tx. Md AndersonHostonTexas77030-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Local Institution - 0031MilwaukeeWisconsin53226-

Find similar trials in Stanford, CA

By research site
Stanford University Medical Center· Stanford, CAH. Lee Moffitt Cancer Center· Tampa, FLLocal Institution - 0001· Atlanta, GALocal Institution - 0002· Chicago, ILLocal Institution - 0004· Metairie, LABeth Israel Deaconess Medical Center· Boston, MA

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