Phase 2 Study of NAI, HPV Vaccine, and Nab-Paclitaxel in HPV-Positive Oropharyngeal Cancer Followed by De-Intensified Radiation Compared With Standard Chemoradiation

This Phase 2a/2 study evaluates the safety, tolerability, and efficacy of neoadjuvant and adjuvant NAI, hAd5-HPV vaccine (IBRX-042), and nab-paclitaxel in participants with locally advanced HPV-positive oropharyngeal squamous cell carcinoma (OPSCC). The study includes a Phase 2a safety lead-in followed by a randomized Phase 2 comparison of a de-intensified experimental chemoradiation approach versus standard-of-care chemoradiation.

NCT Number	NCT07628062
Lead Sponsor	ImmunityBio, Inc.
Conditions	HPV-Positive Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer
Enrollment	70 participants
Start Date	2026-07-22
Primary Completion	2030-12-31 (estimated)
Study Completion	2031-06-27 (estimated)
Updated on ClinicalTrials.gov	2026-06-04