RecruitingPhase 2NCT07290621

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


Sponsor

University of Chicago

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding an immunotherapy drug (toripalimab) to standard chemoradiation therapy improves outcomes for people with HPV16-positive throat cancer (specifically oropharyngeal squamous cell carcinoma) that has spread to nearby lymph nodes or involves larger tumors. **You may be eligible if...** - You have been diagnosed with HPV16-positive squamous cell cancer of the throat (oropharynx) - Your cancer is at an advanced stage (spread to lymph nodes or involves a large primary tumor) - You are at least 18 years old - You have at least one measurable tumor - You are in good enough health to undergo chemoradiation **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have serious immune system problems or autoimmune disease - You have had prior treatment that would prevent you from safely receiving the study treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

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).

DRUGCarboplatin

Carboplatin will be given by Intravenous (IV) infusion once on Day 1 of each treatment cycle.

DRUGPaclitaxel

Paclitaxel will be given by Intravenous (IV) infusion once weekly for 9 weeks (except for Day 22 of cycle 1).


Locations(1)

The University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

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NCT07290621


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