NCT03386838 - 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 | Biotech Hunter

Timeline

Start Date

March 28, 2018

Primary Completion Date

April 19, 2018

Study Completion Date

April 19, 2018

Conditions

Head and Neck Cancer

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified days

DRUG

BMS-986205

Administered 100mg orally once daily for a maximum of 104 weeks

BIOLOGICAL

Cetuximab

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

DRUG

Cisplatin

Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)

DRUG

Carboplatin

Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)

DRUG

Fluorouracil

1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)

Trial Locations (1)

15212-0000

Allegheny General Hospital, Pittsburgh