Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03349710
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 — BIOLOGICAL
    Specified dose on specified day
  • Cetuximab — DRUG
    Specified dose on specified day
  • Cisplatin — DRUG
    Specified dose on specified day
  • Radiotherapy — RADIATION
    Specified dose on specified day

Study Details

This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

Key Dates

Start date
Dec 15, 2017
Status verified
Aug 2021
Primary completion
Oct 14, 2019
Completion
Oct 14, 2019

Study Design

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

Arms

  • Experimental: Arm A
    Cohort 1
  • Experimental: Arm B
    Cohort 1
  • Experimental: Arm C
    Cohort 2
  • Experimental: Arm D
    Cohort 2

Primary Outcome Measure

Number of Participants With an Adverse Event (AE) [ Time Frame: 30 Days ]

Locations (21)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group, LlcAnnistonAlabama36207-
Cancer Treatment Centers of PhoneixGoodyearArizona85338-
University of Arizona Cancer CenterTucsonArizona85724-5024-
UCLA HealthLos AngelesCalifornia90095-
Cancer Care - Torrance Memorial Physician NetworkRedondo BeachCalifornia90277-
Cancer Center of Central ConnecticutPlainvilleConnecticut06062-
Orlando Health, IncOrlandoFlorida32806-
Winship Cancer Insitute, Emory Crawford Long HospitalAtlantaGeorgia30308-
CTCA Southeastern RegionNewnanGeorgia30265-
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial HospitalThomasvilleGeorgia31792-
Midwestern Regional medical CenterZionIllinois60099-
Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndiana46845-
University of Kansas Cancer CenterWestwoodKansas66205-
Nebraska Methodist HospitalOmahaNebraska68114-4108-
Monter Cancer Center - Center for Advanced Medicine LocationLake SuccessNew York11042-
Eastern Regional Medical CenterPhiladelphiaPennsylvania19124-
Upmc- Hillman Cancer CenterPittsburghPennsylvania15232-
St. Joseph Regional Cancer CenterBryanTexas77802-2585-
The University of Texas MD Anderson Cancer Center-mergeHoustonTexas77030-
Inova Health SystemFalls ChurchVirginia22042-
HHP Hematology & Oncology BremertonBremertonWashington98310-

Find similar trials in Anniston, AL

By research site
Pinnacle Research Group, Llc· Anniston, ALCancer Treatment Centers of Phoneix· Goodyear, AZUniversity of Arizona Cancer Center· Tucson, AZUCLA Health· Los Angeles, CACancer Care - Torrance Memorial Physician Network· Redondo Beach, CACancer Center of Central Connecticut· Plainville, CT

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