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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
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* Biological: Nivolumab
* Drug: Cetuximab
* Drug: Cisplatin
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Cohort 1 | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: Opdivo;Radiation: Radiotherapy<br>* Specified dose on specified day<br>|
| Experimental: Arm B<br>Cohort 1 | Drug: Cetuximab<br>* Specified dose on specified day<br>* Other names: Erbitux;Radiation: Radiotherapy<br>* Specified dose on specified day<br>|
| Experimental: Arm C<br>Cohort 2 | Biological: Nivolumab<br>* Specified dose on specified day<br>* Other names: Opdivo;Drug: Cisplatin<br>* Specified dose on specified day<br>Radiation: Radiotherapy<br>* Specified dose on specified day<br>|
| Experimental: Arm D<br>Cohort 2 | Drug: Cisplatin<br>* Specified dose on specified day<br>Radiation: Radiotherapy<br>* Specified dose on specified day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |