Clinical Trials /

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

NCT03349710

Description:

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

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03349710

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
  • Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Clinical Trial IDs

  • ORG STUDY ID: CA209-9TM
  • SECONDARY ID: 2017-002676-87
  • NCT ID: NCT03349710

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoArm A
CetuximabErbituxArm A
PlaceboArm B
CisplatinArm C

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalCohort 1
    Arm BExperimentalCohort 1
    • Placebo
    Arm CExperimentalCohort 2
    • Cisplatin
    Arm DExperimentalCohort 2
    • Placebo
    • Cisplatin

    Eligibility Criteria

            For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of
             the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx

          -  Locally advanced disease which is unresectable, or resectable but suitable for an
             organ sparing approach

          -  No previous radiotherapy or systemic treatment for SCCHN

        Exclusion Criteria:

          -  Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma
             that originated from the skin and salivary gland or non-squamous histology (e.g.,
             mucosal melanoma), squamous cell carcinoma of unknown primary

          -  Clinical or radiological evidence of metastatic disease

          -  Prior radiotherapy that overlaps with radiation fields

        Other protocol defined inclusion/exclusion criteria could apply
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Event Free Survival (EFS)
    Time Frame:Up to 6 years
    Safety Issue:
    Description:EFS is defined as the time from randomization to radiographic progression, as determined by a Blinded Independent Central Review (BICR)

    Secondary Outcome Measures

    Measure:Duration of loco-regional control (DLRC)
    Time Frame:Up to 6 years
    Safety Issue:
    Description:DLRC is defined as the time from randomization to loco-regional relapse
    Measure:Overall Survival (OS)
    Time Frame:Up to 6 years
    Safety Issue:
    Description:OS is defined as time from randomization until death from any cause
    Measure:European Organisation for the Research and Treatment of Cancer (EORTC)
    Time Frame:Up to one year
    Safety Issue:
    Description:Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score
    Measure:Quality of Life Questionnaire-Core 30 (QLQ-C30)
    Time Frame:Up to one year
    Safety Issue:
    Description:Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score
    Measure:European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Head and Neck (QLQQH&N35)
    Time Frame:Up to one year
    Safety Issue:
    Description:Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Bristol-Myers Squibb

    Last Updated

    April 27, 2018