Recruiting
Phase 2

Toripalimab & Chemotherapy

Sponsor:

University of Chicago

Code:

NCT07290621

Conditions

Oropharyngeal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Toripalimab

Carboplatin

Paclitaxel

Study Details

Brief 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

Study ID

NCT07290621

Start date

Feb, 2026

Status verified date

Feb, 2026

Completion date

Feb, 2033

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects must have pathologically confirmed HPV16-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
  • HPV16 subtype demonstrated based on the following guidelines:

  • p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al72).
  • HPV PCR must demonstrate HPV16 subtype.
  • Following p16 IHC positivity, HPV16 is to be demonstrated using HPV PCR which is anticipated to result prior to cycle 1 day 15.
  • Patients must be at least 18 years of age.
  • 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.
  • No previous radiation or chemotherapy for a head and neck cancer.
  • 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.) No surgical procedures or biopsies will occur after baseline scans are performed and measurable lesions are identified.
  • ECOG performance status 0-1
  • Normal Organ Function per protocol criteria
  • Patients must be considered to be a candidate to receive cisplatin by the treating physician.
  • Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding.
  • Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment.
  • Men who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

Exclusion Criteria:

  • Unequivocal demonstration of distant metastatic disease (M1 disease).
  • Non-HPV16 subtype.
  • Unidentifiable primary site.
  • Intercurrent medical illnesses that impairs the patient's tolerance to therapy or limits survival. This includes but is not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance. Patients with clinically stable and/or chronically managed medical illnesses that are not symptomatic and/or are not expected to impact treatment on protocol are still eligible (conditions to be reviewed by the PI to confirm eligibility).
  • Subject with low risk N1 disease (defined as single lymph node <3cm)
  • Active, known, or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy, with the exception of low-dose prednisone (<= 10mg or equivalent). The following are exceptions to these criteria:

  • Patients with vitiligo or alopecia.
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
  • Any chronic skin condition that does not require systemic treatment.
  • Treatment with immunosuppressive or replacement medication:
  • Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses > 10 mg/day prednisone or equivalent), within 14 days of the first administration of study treatment. Note: inhaled or topical steroids and adrenal replacement in doses equivalent to > 10 mg/day prednisone are permitted in the absence of active autoimmune disease.
  • Any chronic immunosuppressive medication within 6 months prior to the first administration of study treatment (unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis).
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients who have had a prior anaphylactic or other severe reaction to human immunoglobulin or antibody formulation administration.
  • Herbal remedies with immune-stimulating properties or known to potentially interfere with major organ function within 28 days prior to the first dose of study treatment, unless agreed otherwise with the primary investigator.
  • 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.
  • Patients receiving other investigational agents.
  • Prior systemic anti-cancer treatment within the last 8 weeks.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence life expectancy in the subsequent 3 years without active treatment.
  • Has known history of, or any evidence of active, non-infectious pneumonitis.
  • Has known active Hepatitis B or hepatitis C. If eradicated, patient is eligible.
  • Has received a live vaccine within 28 days of planned start of study therapy.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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).

Carboplatin

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

Paclitaxel

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Cancer Trials Intake

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

The University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Ari Rosenberg

arirosenberg@bsd.uchicago.edu

Principal Investigator:

Ari Rosenberg

More Information

Sponsor

University of Chicago

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-06.