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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

This study is currently recruiting participants.
Verified December 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT03349710
First Posted: November 21, 2017
Last Update Posted: December 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
ONO Pharmaceutical Co.
Information provided by (Responsible Party):
Bristol-Myers Squibb
November 17, 2017
November 21, 2017
December 7, 2017
November 22, 2017
October 19, 2022   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03349710 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
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)
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Squamous Cell Carcinoma of the Head and Neck
  • Biological: Nivolumab
    Specified dose on specified day
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Cetuximab
    Specified dose on specified day
    Other Name: Erbitux
  • Drug: Placebo
    Specified dose on specified day
  • Drug: Cisplatin
    Specified dose on specified day
  • Radiation: Radiotherapy
    Specified dose on specified day
  • Experimental: Arm A
    Cohort 1
    Interventions:
    • Biological: Nivolumab
    • Biological: Cetuximab
    • Radiation: Radiotherapy
  • Experimental: Arm B
    Cohort 1
    Interventions:
    • Biological: Cetuximab
    • Drug: Placebo
    • Radiation: Radiotherapy
  • Experimental: Arm C
    Cohort 2
    Interventions:
    • Biological: Nivolumab
    • Drug: Cisplatin
    • Radiation: Radiotherapy
  • Experimental: Arm D
    Cohort 2
    Interventions:
    • Drug: Placebo
    • Drug: Cisplatin
    • Radiation: Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1046
October 20, 2022
October 19, 2022   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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 #.
Australia,   Brazil,   Korea, Republic of,   Romania,   Russian Federation,   Spain,   Taiwan,   United States
 
 
NCT03349710
CA209-9TM
2017-002676-87 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
ONO Pharmaceutical Co.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2017

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