drugset / Trial / NCT03349710

Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

NCT03349710

RandomizedParallel-groupOpen-labelTreatment

Summary

This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

Timeline

Start
2017-12-15
Primary completion
2019-10-14
Completion
2019-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody
Subject Nivolumab Monoclonal antibody
Background Cisplatin Other / unclassified