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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
  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

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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 1046
Actual Study Start Date: November 22, 2017
Estimated Study Completion Date: October 20, 2022
Estimated Primary Completion Date: October 19, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Cohort 1
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo
Biological: Cetuximab
Specified dose on specified day
Other Name: Erbitux
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
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 #.

Locations
United States, Alabama
Pinnacle Research Group, Llc Recruiting
Anniston, Alabama, United States, 36207
Contact: Aasim Sehbai, Site 0015    256-236-0055      
United States, Delaware
Local Institution Not yet recruiting
Newark, Delaware, United States, 19713
Contact: Site 0013         
United States, Georgia
Local Institution Not yet recruiting
Newnan, Georgia, United States, 30265
Contact: Site 0021         
United States, Michigan
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Site 0001         
Australia, New South Wales
Local Institution Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Site 0020         
Local Institution Not yet recruiting
Gosford, New South Wales, Australia
Contact: Site 0019         
Brazil
Local Institution Not yet recruiting
Lajeado, RIO Grande DO SUL, Brazil, 95900-010
Contact: Site 0010         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90050-170
Contact: Site 0008         
Local Institution Not yet recruiting
Joinville, Santa Catarina, Brazil, 89201-260
Contact: Site 0014         
Local Institution Not yet recruiting
Ribeirao Preto, SAO Paulo, Brazil, 14015-130
Contact: Site 0011         
Local Institution Not yet recruiting
Santo Andre, SAO Paulo, Brazil, 09060-0650
Contact: Site 0016         
Local Institution Not yet recruiting
Sao Jose do Rio Preto, SAO Paulo, Brazil, 15090-000
Contact: Site 0007         
Local Institution Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Contact: Site 0024         
Local Institution Not yet recruiting
Sao Paulo, Brazil, 01221-020
Contact: Site 0009         
Korea, Republic of
Local Institution Not yet recruiting
Seongnam, Gyeonggy-do, Korea, Republic of, 463-707
Contact: Site 0110         
Romania
Local Institution Not yet recruiting
Cluj Napoca, Romania, 400058
Contact: Site 0023         
Russian Federation
Local Institution Not yet recruiting
Omsk, Russian Federation, 644013
Contact: Site 0002         
Local Institution Not yet recruiting
Yekaterinburg, Russian Federation, 620043
Contact: Site 0025         
Spain
Local Institution Not yet recruiting
Madrid, Spain, 28942
Contact: Site 0022         
Local Institution Not yet recruiting
Valencia, Spain, 46015
Contact: Site 0017         
Taiwan
Local Institution Not yet recruiting
Tainan, Taiwan, 704
Contact: Site 0090         
Local Institution Not yet recruiting
Taipei, Taiwan, 10449
Contact: Site 0087         
Sponsors and Collaborators
Bristol-Myers Squibb
ONO Pharmaceutical Co.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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 Submitted: November 17, 2017
First Posted: November 21, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017

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