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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified dose on specified days
Administered 100mg orally once daily for a maximum of 104 weeks
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
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Progression-free survival (PFS) as determined by Blinded Independent Central Review (BICR) using RECIST 1.1
Time frame: Approximately 2 years
Overall survival (OS)
Time frame: Approximately 40 months
Objective response rate (ORR) determined by BICR using RECIST 1.1
Time frame: Approximately 2 years
Number of adverse events (AE)
Time frame: Approximately 2 years
Number of serious adverse events (SAE)
Time frame: Approximately 2 years
Time to meaningful symptomatic deterioration (TTSD)
Time frame: Approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)