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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03349710
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE December 15, 2017
Actual Primary Completion Date October 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Incidence of adverse events (AEs) [ Time Frame: Up to 12 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
Event Free Survival (EFS) [ Time Frame: Up to 6 years ]
EFS is defined as the time from randomization to radiographic progression, as determined by a Blinded Independent Central Review (BICR)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Duration of loco-regional control (DLRC) [ Time Frame: Up to 6 years ]
    DLRC is defined as the time from randomization to loco-regional relapse
  • Overall Survival (OS) [ Time Frame: Up to 6 years ]
    OS is defined as time from randomization until death from any cause
  • European Organisation for the Research and Treatment of Cancer (EORTC) [ Time Frame: Up to one year ]
    Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score
  • Quality of Life Questionnaire-Core 30 (QLQ-C30) [ Time Frame: Up to one year ]
    Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score
  • European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Head and Neck (QLQQH&N35) [ Time Frame: Up to one year ]
    Proportion without meaningful symptom deterioration after 1 year is defined as the proportion with no meaningful worsening in a disease-related symptom score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • BMS-936558
    • Opdivo
  • Drug: Cetuximab
    Specified dose on specified day
    Other Name: Erbitux
  • Drug: Cisplatin
    Specified dose on specified day
  • Radiation: Radiotherapy
    Specified dose on specified day
Study Arms  ICMJE
  • Experimental: Arm A
    Cohort 1
    Interventions:
    • Biological: Nivolumab
    • Radiation: Radiotherapy
  • Experimental: Arm B
    Cohort 1
    Interventions:
    • Drug: Cetuximab
    • Radiation: Radiotherapy
  • Experimental: Arm C
    Cohort 2
    Interventions:
    • Biological: Nivolumab
    • Drug: Cisplatin
    • Radiation: Radiotherapy
  • Experimental: Arm D
    Cohort 2
    Interventions:
    • Drug: Cisplatin
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2019)
68
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
1046
Actual Study Completion Date  ICMJE October 14, 2019
Actual Primary Completion Date October 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries Australia,   Brazil,   Canada,   Colombia,   Romania
 
Administrative Information
NCT Number  ICMJE NCT03349710
Other Study ID Numbers  ICMJE CA209-9TM
2017-002676-87 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP