Back to resultsNivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Cetuximab
Cisplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility 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
Sites / Locations
- Pinnacle Research Group, Llc
- Cancer Treatment Centers of Phoneix
- University of Arizona Cancer Center
- UCLA Health
- Cancer Care - Torrance Memorial Physician Network
- Cancer Center of Central Connecticut
- Orlando Health, Inc
- Winship Cancer Insitute, Emory Crawford Long Hospital
- CTCA Southeastern Region
- Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
- Midwestern Regional medical Center
- Fort Wayne Medical Oncology and Hematology, Inc.
- University of Kansas Cancer Center
- Nebraska Methodist Hospital
- Monter Cancer Center - Center for Advanced Medicine Location
- Eastern Regional Medical Center
- Upmc- Hillman Cancer Center
- St. Joseph Regional Cancer Center
- The University of Texas MD Anderson Cancer Center-merge
- Inova Health System
- HHP Hematology & Oncology Bremerton
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm C
Arm D
Arm Description
Cohort 1
Cohort 1
Cohort 2
Cohort 2
Outcomes
Primary Outcome Measures
Number of Participants With an Adverse Event (AE)
Number of Participants with an Adverse Event
Number of Participants With an Serious Adverse Event (SAE)
Number of Participants with an Serious Adverse Event (SAE)
Number of Participants With an Adverse Event Leading to Discontinuation
Number of Participants with an Adverse Event Leading to Discontinuation
Number of Participants With an Adverse Event Leading to Dose Modification
Number of Participants with an Adverse Event Leading to dose modification
Number of Participants With Select Adverse Events
Number of Participants with select adverse events.
Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Number of Participants with an immune-mediated adverse event (IMAE)
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time to onset and time to resolution of immune-related adverse events
Number of Participants Who Experienced Death
Number of Participants who experienced death
Number of Participants With an Abnormality in Specific Thyroid Tests
Number of participants with an abnormality in specific thyroid tests
Number of Participants With an Abnormality in Specific Liver Tests
Number of participants with an abnormality in specific liver tests
Secondary Outcome Measures
Full Information
NCT ID
NCT03349710
First Posted
November 17, 2017
Last Updated
August 5, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03349710
Brief Title
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
October 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Cohort 1
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Cohort 1
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Cohort 2
Arm Title
Arm D
Arm Type
Experimental
Arm Description
Cohort 2
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
Erbitux
Intervention Description
Specified dose on specified day
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Specified dose on specified day
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Specified dose on specified day
Primary Outcome Measure Information:
Title
Number of Participants With an Adverse Event (AE)
Description
Number of Participants with an Adverse Event
Time Frame
30 Days
Title
Number of Participants With an Serious Adverse Event (SAE)
Description
Number of Participants with an Serious Adverse Event (SAE)
Time Frame
30 days
Title
Number of Participants With an Adverse Event Leading to Discontinuation
Description
Number of Participants with an Adverse Event Leading to Discontinuation
Time Frame
30 Days
Title
Number of Participants With an Adverse Event Leading to Dose Modification
Description
Number of Participants with an Adverse Event Leading to dose modification
Time Frame
30 Days
Title
Number of Participants With Select Adverse Events
Description
Number of Participants with select adverse events.
Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Time Frame
30 Days
Title
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Description
Number of Participants with an immune-mediated adverse event (IMAE)
Time Frame
100 days
Title
Time to Onset and Time to Resolution of Immune-related Adverse Events
Description
Time to onset and time to resolution of immune-related adverse events
Time Frame
100 days
Title
Number of Participants Who Experienced Death
Description
Number of Participants who experienced death
Time Frame
100 days
Title
Number of Participants With an Abnormality in Specific Thyroid Tests
Description
Number of participants with an abnormality in specific thyroid tests
Time Frame
30 Days
Title
Number of Participants With an Abnormality in Specific Liver Tests
Description
Number of participants with an abnormality in specific liver tests
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, Llc
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Cancer Treatment Centers of Phoneix
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cancer Care - Torrance Memorial Physician Network
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Plainville
State/Province
Connecticut
ZIP/Postal Code
06062
Country
United States
Facility Name
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Winship Cancer Insitute, Emory Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
CTCA Southeastern Region
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Midwestern Regional medical Center
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4108
Country
United States
Facility Name
Monter Cancer Center - Center for Advanced Medicine Location
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
Upmc- Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
St. Joseph Regional Cancer Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802-2585
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center-merge
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
HHP Hematology & Oncology Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Local Institution
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
6100
Country
France
Facility Name
Local Institution
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Local Institution
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Local Institution
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
2778577
Country
Japan
Facility Name
Local Institution
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Local Institution
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
6738558
Country
Japan
Facility Name
Local Institution
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500017
Country
Japan
Facility Name
Local Institution
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
2591193
Country
Japan
Facility Name
Local Institution
City
Natori-shi
State/Province
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Local Institution
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution
City
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
Local Institution
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Local Institution
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Local Institution
City
Gdynia
ZIP/Postal Code
81 519
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
129515
Country
Russian Federation
Facility Name
Local Institution
City
Yekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Local Institution
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Izmir
ZIP/Postal Code
35000
Country
Turkey
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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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