Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Interventions
- Registration Number
- NCT03349710
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm C Radiotherapy Cohort 2 Arm B Cetuximab Cohort 1 Arm A Radiotherapy Cohort 1 Arm A Nivolumab Cohort 1 Arm B Radiotherapy Cohort 1 Arm D Radiotherapy Cohort 2 Arm C Nivolumab Cohort 2 Arm C Cisplatin Cohort 2 Arm D Cisplatin Cohort 2
- Primary Outcome Measures
Name Time Method Number of Participants With an Adverse Event Leading to Dose Modification 30 Days Number of Participants with an Adverse Event Leading to dose modification
Number of Participants With Select Adverse Events 30 Days Number of Participants with select adverse events.
Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.Number of Participants Who Experienced Death 100 days Number of Participants who experienced death
Number of Participants With an Abnormality in Specific Liver Tests 30 days Number of participants with an abnormality in specific liver tests
Number of Participants With an Serious Adverse Event (SAE) 30 days Number of Participants with an Serious Adverse Event (SAE)
Number of Participants With an Adverse Event Leading to Discontinuation 30 Days Number of Participants with an Adverse Event Leading to Discontinuation
Number of Participants With an Adverse Event (AE) 30 Days Number of Participants with an Adverse Event
Number of Participants With an Immune-mediated Adverse Event (IMAE) 100 days Number of Participants with an immune-mediated adverse event (IMAE)
Time to Onset and Time to Resolution of Immune-related Adverse Events 100 days Time to onset and time to resolution of immune-related adverse events
Number of Participants With an Abnormality in Specific Thyroid Tests 30 Days Number of participants with an abnormality in specific thyroid tests
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Cancer Treatment Centers of Phoneix
🇺🇸Goodyear, Arizona, United States
Pinnacle Research Group, Llc
🇺🇸Anniston, Alabama, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Cancer Care - Torrance Memorial Physician Network
🇺🇸Redondo Beach, California, United States
CTCA Southeastern Region
🇺🇸Newnan, Georgia, United States
Orlando Health, Inc
🇺🇸Orlando, Florida, United States
Winship Cancer Insitute, Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
🇺🇸Thomasville, Georgia, United States
Fort Wayne Medical Oncology and Hematology, Inc.
🇺🇸Fort Wayne, Indiana, United States
Midwestern Regional medical Center
🇺🇸Zion, Illinois, United States
St. Joseph Regional Cancer Center
🇺🇸Bryan, Texas, United States
Monter Cancer Center - Center for Advanced Medicine Location
🇺🇸Lake Success, New York, United States
Upmc- Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Eastern Regional Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Inova Health System
🇺🇸Falls Church, Virginia, United States
The University of Texas MD Anderson Cancer Center-merge
🇺🇸Houston, Texas, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
Cancer Center of Central Connecticut
🇺🇸Plainville, Connecticut, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Local Institution
🇹🇷Izmir, Turkey
HHP Hematology & Oncology Bremerton
🇺🇸Bremerton, Washington, United States