drugset / Trial / NCT01935921

Ipilimumab, Cetuximab, and Intensity-Modulated Radiation Therapy in Treating Patients With Previously Untreated Stage III-IVB Head and Neck Cancer

NCT01935921

Phase 1 Completed 19 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase Ib trial studies the side effects and best dose of ipilimumab when given together with cetuximab and intensity-modulated radiation therapy (IMRT) in treating patients with previously untreated stage III-IVB head and neck cancer. Monoclonal antibodies, such as ipilimumab and cetuximab, may block tumor growth in different ways by targeting certain cells. Specialized radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving ipilimumab together with cetuximab and IMRT may kill more tumor cells.

Timeline

Start
2013-04-09
Primary completion
2016-10-29
Completion
2018-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Ipilimumab Monoclonal antibody 3 mg/kg Intravenous
Background Cetuximab Monoclonal antibody Intravenous