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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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