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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-03-28
• Primary completion: 2018-04-19
• Completion: 2018-04-19
• First posted: 2017-12-29
• Last updated: 2019-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study