drugset / Trial / 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

NCT03386838

Phase 3 Withdrawn Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-03-28
Primary completion
2018-04-19
Completion
2018-04-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 5 unknown
Comparator Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Comparator Cisplatin Other / unclassified 100 mg/m2
Subject LINRODOSTAT Small molecule 100 mg Oral
Subject Nivolumab Monoclonal antibody
Comparator fluorouracil Small molecule 1000 mg/m2

Indications