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Oropharyngeal CancerPhase 2NCT07290621

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

A Phase 2 study testing Toripalimab, Carboplatin and Paclitaxel in people with Oropharyngeal Cancer, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oropharyngeal Cancer
What is being tested?
Toripalimab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Feb 2026to Feb 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cancer Trials Intake contact

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

United States1 site, 1 recruiting

  • The University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Ari Rosenberg, arirosenberg@bsd.uchicago.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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).

Medical subject headings
Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToripalimabDrug

    Also called LOQTORZI

    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).

  • CarboplatinDrug

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

  • PaclitaxelDrug

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

Study groups in NCT07290621
Study groupRoleWhat they receive
Toripalimab and Chemotherapy TreatmentExperimentalParticipants will receive toripalimab with neoadjuvant chemotherapy. After completion of the study treatment all patients will proceed with risk and response stratified locoregional therapy.
Receives: Drug: Toripalimab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deep Response Rate (DRR) with toripalimab + chemotherapy

    The proportion of patients who attain a deep response following neoadjuvant toriaplimab + chemotherapy. DDR is defined as tumor shrinkage by 50% or more.

    Measured: After treatment completion (about 3 months)

Secondary outcomes (6)

  1. Side effects of toripalimab + chemotherapy

    Summary of side effects seen by types and severity and relatedness to study treatment as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.

    Measured: After treatment completion (about 3 months)

  2. Progression Free Survival

    Time to disease worsening will be calculated

    Measured: 5 years after treatment completion

  3. Overall Survival

    Time to death will be calculated

    Measured: 5 years after treatment completion

  4. Locoregional Control

    Time to local disease worsening will be calculated

    Measured: 5 years after treatment completion

  5. Distant Control

    Time to disease worsening or spreading to other parts of the body

    Measured: 5 years after treatment completion

  6. Treatment adherence

    Dose delays, dose reductions, and chemotherapy discontinuations during neoadjuvant treatment will be summarized by type, worst grade, and attribution.

    Measured: After treatment completion (about 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study startFeb 2026 (estimated)
  3. Primary completionFeb 2030 (estimated)
  4. Study completionFeb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290621
Sponsor's protocol ID
IRB25-1616
Status last verified
Feb 2026
First submitted
12 Dec 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Carboplatin and Paclitaxel in people with Oropharyngeal Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cancer Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deep Response Rate (DRR) with toripalimab + chemotherapy (time frame: After treatment completion (about 3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07290621.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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