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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07290621
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    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).
  • Carboplatin — DRUG
    Carboplatin will be given by Intravenous (IV) infusion once on Day 1 of each treatment cycle.
  • Paclitaxel — DRUG
    Paclitaxel will be given by Intravenous (IV) infusion once weekly for 9 weeks (except for Day 22 of cycle 1).

Study Details

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).

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2033

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Toripalimab and Chemotherapy Treatment
    Participants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.

Primary Outcome Measure

Deep Response Rate (DRR) with toripalimab + chemotherapy [ Time Frame: After treatment completion (about 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
855-702-8222
Ari Rosenberg
Ari Rosenberg (PRINCIPAL_INVESTIGATOR)

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