NCT03829722

Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Phase II Trial of Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-Related Oropharynx Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PCD details were updated as RECIST is not appropriate for tumor response assessment in this population. Tumor response will be assessed via clinical assessment and PET response (determining progression and location, if any evidence of disease).

Conditions

• Oropharynx Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
DRUG	Carboplatin	Given IV once per week during radiation therapy (AUC=1).
DRUG	Paclitaxel	Given IV once per week during radiation therapy (30mg/m\^2)
RADIATION	Radiation Therapy	Given 5 days/week for a total of 35 doses (70 gray total).

Timeline

• Start date: 2019-09-05
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2019-02-04
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study