OncoMatch/Clinical Trials/NCT07290621
Toripalimab in Combination With Standard Treatment for Human Papillomavirus (HPV) Positive Throat Cancer
Is NCT07290621 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Carboplatin for oropharyngeal cancer.
Treatment: Toripalimab · Carboplatin · Paclitaxel — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV16 positive
HPV16 subtype demonstrated based on the following guidelines: HPV PCR must demonstrate HPV16 subtype.
Required: CDKN2A p16 overexpression (IHC positive)
p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).
Disease stage
Required: Stage N1 (IF SOLITARY LYMPH NODE MUST BE >=3CM), T3 (WITH ANY N), T4 (WITH ANY N) (AJCC (8th edition, 2018))
Subjects with AJCC (8th edition, 2018) N1 (if solitary lymph node must be >=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N). Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria. Unequivocal demonstration of distant metastatic disease (M1 disease) [excluded]. Subject with low risk N1 disease (defined as single lymph node <3cm) [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
No previous radiation or chemotherapy for a head and neck cancer.
Cannot have received: chemotherapy
No previous radiation or chemotherapy for a head and neck cancer.
Cannot have received: systemic anti-cancer treatment
Prior systemic anti-cancer treatment within the last 8 weeks.
Cannot have received: surgery
Exception: incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors with residual measurable tumor
No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual measurable disease is acceptable.) Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.
Lab requirements
Blood counts
Normal Organ Function per protocol criteria
Kidney function
Normal Organ Function per protocol criteria
Liver function
Normal Organ Function per protocol criteria
Normal Organ Function per protocol criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Chicago Medicine Comprehensive Cancer Center · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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