An Immuno-therapy Study of Nivolumab in Combination With Experimental Medication BMS-986205 Compared to Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Study Overview
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Brief Summary
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This is a study of Nivolumab in combination with experimental medication BMS-986205 compared to the standard of care EXTREME regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.

Official Title
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A Randomized, Global, Open-label Study of Nivolumab in Combination With BMS-986205 vs Standard of Care EXTREME Regimen in First-line Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Biological: Nivolumab
* Drug: BMS-986205
* Biological: Cetuximab
* Drug: Cisplatin
* Drug: Carboplatin
* Drug: Fluorouracil


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 confirmed squamous cell carcinoma of the head and neck (SCCHN), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx. Recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy) No prior treatment with systemic anti-cancer therapy for SCCHN, unless protocol specified criteria are met ECOG Performance Status of 0-1 Measurable disease by CT or MRI per RECIST 1.1 criteria Exclusion Criteria: Women who are pregnant or breastfeeding Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma) Participants with untreated CNS metastases are excluded Participants with carcinomatous meningitis Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast 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: Nivolumab and BMS-986205<br>Nivolumab administered in combination with BMS-986205 | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: BMS-986205<br>* Administered 100mg orally once daily for a maximum of 104 weeks<br>|
| Active Comparator: EXTREME study regimen<br>Cetuximab + Cisplatin/Carboplatin + Fluorouracil | Biological: Cetuximab<br>* 400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason<br>Drug: Cisplatin<br>* Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)<br>Drug: Carboplatin<br>* Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)<br>Drug: Fluorouracil<br>* 1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1 |  | Approximately 2 years | 
| Overall survival (OS) |  | Approximately 40 months | 
| Objective response rate (ORR) determined by BICR using RECIST 1.1 |  | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events (AE) |  | Approximately 2 years | 
| Number of serious adverse events (SAE) |  | Approximately 2 years | 
| Time to meaningful symptomatic deterioration (TTSD) |  | Approximately 2 years |