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

August 5, 2021 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Local Institution
      • Marseille, France, 13005
        • Local Institution
      • Nice, France, 6100
        • Local Institution
  • Italy
      • Lucca, Italy, 55100
        • Local Institution
      • Ravenna, Italy, 48121
        • Local Institution
  • Japan
      • Osaka, Japan, 5418567
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-0280
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8128582
        • Local Institution
    • Hyogo
      • Akashi-shi, Hyogo, Japan, 6738558
        • Local Institution
      • Kobe-shi, Hyogo, Japan, 6500017
        • Local Institution
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 3058576
        • Local Institution
    • Kanagawa
      • Isehara, Kanagawa, Japan, 2591193
        • Local Institution
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Local Institution
  • Korea, Republic of
      • Cheongju-si, Korea, Republic of, 28644
        • Local Institution
      • Jeollanam-do, Korea, Republic of, 58128
        • Local Institution
      • Seoul, Korea, Republic of, 06591
        • Local Institution
      • Seoul, Korea, Republic of, 06351
        • Local Institution
  • Poland
      • Gdynia, Poland, 81 519
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 129515
        • Local Institution
      • Yekaterinburg, Russian Federation, 620036
        • Local Institution
  • Spain
      • A Coruna, Spain, 15706
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Madrid, Spain, 28046
        • Local Institution
      • Madrid, Spain, 28942
        • Local Institution
      • Majadahonda, Spain, 28222
        • Local Institution
      • Valencia, Spain, 46015
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, 40447
        • Local Institution
      • Taichung, Taiwan, 40705
        • Local Institution
      • Tainan, Taiwan, 704
        • Local Institution
  • Turkey
      • Izmir, Turkey, 35000
        • Local Institution
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Cancer Treatment Centers of Phoneix
      • Tucson, Arizona, United States, 85724-5024
        • University of Arizona Cancer Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Health
      • Redondo Beach, California, United States, 90277
        • Cancer Care - Torrance Memorial Physician Network
    • Connecticut
      • Plainville, Connecticut, United States, 06062
        • Cancer Center of Central Connecticut
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Winship Cancer Insitute, Emory Crawford Long Hospital
      • Newnan, Georgia, United States, 30265
        • CTCA Southeastern Region
      • Thomasville, Georgia, United States, 31792
        • Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
    • Illinois
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology, Inc.
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4108
        • Nebraska Methodist Hospital
    • New York
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center - Center for Advanced Medicine Location
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19124
        • Eastern Regional Medical Center
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC- Hillman Cancer Center
    • Texas
      • Bryan, Texas, United States, 77802-2585
        • St. Joseph Regional Cancer Center
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center-merge
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Health System
    • Washington
      • Bremerton, Washington, United States, 98310
        • HHP Hematology & Oncology Bremerton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Cohort 1
Biological: Nivolumab
Specified dose on specified day
Other Names:
  • BMS-936558
  • Opdivo
Radiation: Radiotherapy
Specified dose on specified day
Experimental: Arm B
Cohort 1
Radiation: Radiotherapy
Specified dose on specified day
Drug: Cetuximab
Specified dose on specified day
Other Names:
  • Erbitux
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: Cisplatin
Specified dose on specified day
Radiation: Radiotherapy
Specified dose on specified day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With an Adverse Event (AE)
Time Frame: 30 Days
Number of Participants with an Adverse Event
30 Days
Number of Participants With an Serious Adverse Event (SAE)
Time Frame: 30 days
Number of Participants with an Serious Adverse Event (SAE)
30 days
Number of Participants With an Adverse Event Leading to Discontinuation
Time Frame: 30 Days
Number of Participants with an Adverse Event Leading to Discontinuation
30 Days
Number of Participants With an Adverse Event Leading to Dose Modification
Time Frame: 30 Days
Number of Participants with an Adverse Event Leading to dose modification
30 Days
Number of Participants With Select Adverse Events
Time Frame: 30 Days

Number of Participants with select adverse events.

Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
30 Days
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Time Frame: 100 days
Number of Participants with an immune-mediated adverse event (IMAE)
100 days
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time Frame: 100 days
Time to onset and time to resolution of immune-related adverse events
100 days
Number of Participants Who Experienced Death
Time Frame: 100 days
Number of Participants who experienced death
100 days
Number of Participants With an Abnormality in Specific Thyroid Tests
Time Frame: 30 Days
Number of participants with an abnormality in specific thyroid tests
30 Days
Number of Participants With an Abnormality in Specific Liver Tests
Time Frame: 30 days
Number of participants with an abnormality in specific liver tests
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

October 14, 2019

Study Completion (Actual)

October 14, 2019

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9TM
  • 2017-002676-87 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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