drugset / Trial / NCT03829722
Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer
Phase 2
Completed
26 enrolled
University of Michigan Rogel Cancer Center
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with high risk HPV-related squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate). Fractionated means the radiation will be administered in fragments or parts across multiple days.
Timeline
- Start
- 2019-09-05
- Primary completion
- 2024-06-11
- Completion
- 2024-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | 30 mg/m2 | Intravenous |