NCT07290621

Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer

Phase II Trial of Neoadjuvant Toripalimab in Combination With Chemotherapy Followed by Transoral Robotic Surgery or Risk/Response Stratified Chemoradiotherapy for Locoregional HPV16+ Oropharyngeal Cancer: TARGET HPV Cohort 2

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center phase 2 study of to test how well the combination of toripalimab with chemotherapy followed by TORS or risk and response stratified de-escalated (chemo)radiotherapy works in patients with in HPV16+ locoregionally advanced oropharyngeal cancer (OPC).

Conditions

• Oropharyngeal Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab will be given by Intravenous (IV) infusion once on Day 1 of each treatment cycle. Up to 3 cycles of treatment will be given. The first treatment cycle will last 28 days (4 weeks). Cycles 2 and 3 will last 21 days (3 weeks).
DRUG	Carboplatin	Carboplatin will be given by Intravenous (IV) infusion once on Day 1 of each treatment cycle.
DRUG	Paclitaxel	Paclitaxel will be given by Intravenous (IV) infusion once weekly for 9 weeks (except for Day 22 of cycle 1).

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-02-01
• Completion: 2033-02-01
• First posted: 2025-12-18
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study