Head and Neck Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALNivolumab
Specified dose on specified days
DRUGBMS-986205
Administered 100mg orally once daily for a maximum of 104 weeks
BIOLOGICALCetuximab
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
DRUGCisplatin
Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
DRUGCarboplatin
Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
DRUGFluorouracil
1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed