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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

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ClinicalTrials.gov Identifier: NCT03349710
Recruitment Status : Recruiting
First Posted : November 21, 2017
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
ONO Pharmaceutical Co.
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: Nivolumab Biological: Cetuximab Drug: Placebo Drug: Cisplatin Radiation: Radiotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1046 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : November 10, 2022
Estimated Study Completion Date : November 11, 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm A
Cohort 1
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo
Drug: Placebo
Specified dose on specified day
Radiation: Radiotherapy
Specified dose on specified day
Experimental: Arm B
Cohort 1
Biological: Cetuximab
Specified dose on specified day
Other Name: Erbitux
Drug: Placebo
Specified dose on specified day
Radiation: Radiotherapy
Specified dose on specified day
Experimental: Arm C
Cohort 2
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo
Drug: Cisplatin
Specified dose on specified day
Radiation: Radiotherapy
Specified dose on specified day
Experimental: Arm D
Cohort 2
Drug: Placebo
Specified dose on specified day
Drug: Cisplatin
Specified dose on specified day
Radiation: Radiotherapy
Specified dose on specified day



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Duration of loco-regional control (DLRC) [ Time Frame: Up to 6 years ]
    DLRC is defined as the time from randomization to loco-regional relapse

  2. Overall Survival (OS) [ Time Frame: Up to 6 years ]
    OS is defined as time from randomization until death from any cause

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349710


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
ONO Pharmaceutical Co.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03349710     History of Changes
Other Study ID Numbers: CA209-9TM
2017-002676-87 ( EudraCT Number )
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Nivolumab
Cisplatin
Cetuximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs