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)
2 other identifiers
interventional
74
10 countries
55
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2017
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2019
CompletedResults Posted
Study results publicly available
August 9, 2021
CompletedAugust 9, 2021
August 1, 2021
1.8 years
November 17, 2017
October 13, 2020
August 5, 2021
Conditions
Outcome Measures
Primary Outcomes (10)
Number of Participants With an Adverse Event (AE)
Number of Participants with an Adverse Event
30 Days
Number of Participants With an Serious Adverse Event (SAE)
Number of Participants with an Serious Adverse Event (SAE)
30 days
Number of Participants With an Adverse Event Leading to Discontinuation
Number of Participants with an Adverse Event Leading to Discontinuation
30 Days
Number of Participants With an Adverse Event Leading to Dose Modification
Number of Participants with an Adverse Event Leading to dose modification
30 Days
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.
30 Days
Number of Participants With an Immune-mediated Adverse Event (IMAE)
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 to onset and time to resolution of immune-related adverse events
100 days
Number of Participants Who Experienced Death
Number of Participants who experienced death
100 days
Number of Participants With an Abnormality in Specific Thyroid Tests
Number of participants with an abnormality in specific thyroid tests
30 Days
Number of Participants With an Abnormality in Specific Liver Tests
Number of participants with an abnormality in specific liver tests
30 days
Study Arms (4)
Arm A
EXPERIMENTALCohort 1
Arm B
EXPERIMENTALCohort 1
Arm C
EXPERIMENTALCohort 2
Arm D
EXPERIMENTALCohort 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (55)
Pinnacle Research Group, Llc
Anniston, Alabama, 36207, United States
Cancer Treatment Centers of Phoneix
Goodyear, Arizona, 85338, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
UCLA Health
Los Angeles, California, 90095, United States
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, 90277, United States
Cancer Center of Central Connecticut
Plainville, Connecticut, 06062, United States
Orlando Health, Inc
Orlando, Florida, 32806, United States
Winship Cancer Insitute, Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
CTCA Southeastern Region
Newnan, Georgia, 30265, United States
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792, United States
Midwestern Regional medical Center
Zion, Illinois, 60099, United States
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46845, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114-4108, United States
Monter Cancer Center - Center for Advanced Medicine Location
Lake Success, New York, 11042, United States
Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124, United States
Upmc- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
St. Joseph Regional Cancer Center
Bryan, Texas, 77802-2585, United States
The University of Texas MD Anderson Cancer Center-merge
Houston, Texas, 77030, United States
Inova Health System
Falls Church, Virginia, 22042, United States
HHP Hematology & Oncology Bremerton
Bremerton, Washington, 98310, United States
Local Institution
Grenoble, 38043, France
Local Institution
Marseille, 13005, France
Local Institution
Nice, 6100, France
Local Institution
Lucca, 55100, Italy
Local Institution
Ravenna, 48121, Italy
Local Institution
Nagoya, Aichi-ken, 4648681, Japan
Local Institution
Kashiwa-shi, Chiba, 2778577, Japan
Local Institution
Matsuyama, Ehime, 791-0280, Japan
Local Institution
Fukuoka, Fukuoka, 8128582, Japan
Local Institution
Akashi-shi, Hyōgo, 6738558, Japan
Local Institution
Kobe, Hyōgo, 6500017, Japan
Local Institution
Tsukuba, Ibaraki, 3058576, Japan
Local Institution
Isehara, Kanagawa, 2591193, Japan
Local Institution
Natori-shi, Miyagi, 981-1293, Japan
Local Institution
Osaka-sayama-shi, Osaka, 5898511, Japan
Local Institution
Bunkyo-ku, Tokyo, 113-8519, Japan
Local Institution
Osaka, 5418567, Japan
Local Institution
Gdynia, 81 519, Poland
Local Institution
Moscow, 129515, Russia
Local Institution
Yekaterinburg, 620036, Russia
Local Institution
Cheongju-si, 28644, South Korea
Local Institution
Jeollanam-do, 58128, South Korea
Local Institution
Seoul, 06351, South Korea
Local Institution
Seoul, 06591, South Korea
Local Institution
A Coruña, 15706, Spain
Local Institution
Barcelona, 08003, Spain
Local Institution
Madrid, 28046, Spain
Local Institution
Madrid, 28942, Spain
Local Institution
Majadahonda, 28222, Spain
Local Institution
Valencia, 46015, Spain
Local Institution
Taichung, 40447, Taiwan
Local Institution
Taichung, 40705, Taiwan
Local Institution
Tainan, 704, Taiwan
Local Institution
Izmir, 35000, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2017
First Posted
November 21, 2017
Study Start
December 15, 2017
Primary Completion
October 14, 2019
Study Completion
October 14, 2019
Last Updated
August 9, 2021
Results First Posted
August 9, 2021
Record last verified: 2021-08