HPV-Negative Squamous Cell CarcinomaPhase 1NCT06005324
Personalized, Adaptive Treatment for Locally Advanced Head and Neck Cancer
A Phase 1 study testing Paclitaxel, Carboplatin and Cetuximab in people with HPV-Negative Squamous Cell Carcinoma, run by University of Chicago at 1 site in United States.
Trial summary
This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Negative Squamous Cell Carcinoma
- What is being tested?
- Paclitaxel, Carboplatin and Cetuximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to Dec 2026
- Phase
- Phase 1
- 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
- Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.
- Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.
- If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
- Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
- Patients must be at least 18 years of age.
- Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.
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- 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 core-needle or excisional biopsies will occur after baseline scans are performed and measurable lesions are identified. Fine-needle aspiration can be performed (i.e., to confirm extent of baseline lymph node involvement) following discussion with PI if not performed on a target lesion.
- Performance status 0-1
- Normal Organ Function
- Leukocytes ≥ 3000/mm3
- Platelets ≥ 100,000/mm3
- Absolute neutrophil count ≥ 1,500
- Hemoglobin ≥ 9.0 gm/dL
- Aspartate Aminotransferase (AST) ≤ 2.5x upper limit of normal
- Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal
- Alkaline phosphatase ≤ 2.5x upper limit of normal
- Albumin > 2.9 gm/dL
- Total bilirubin ≤ 1.5 mg/dL
- Creatinine clearance (CrCl) > 45 mL/min, normal within 2 weeks prior to start of treatment (Of note, the standard Cockcroft and Gault formula must be used to calculate CrCl for enrollment or dosing)
- 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 with study drug(s) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.
- 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) plus 5 months after completing chemoradiation or receiving the last dose of chemoradiation, whichever occurs latest.
Who cannot join
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Unidentifiable primary site.
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit 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).
- 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.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
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- Known history of active tuberculosis (Bacillus Tuberculosis infection).
- Hypersensitivity to cetuximab or any other drug used in this protocol.
- 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 a history of HIV.
- 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.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
About this study
Official title: Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma
This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.
- Conditions
- HPV-Negative Squamous Cell Carcinoma
- Being tested
- Paclitaxel, Carboplatin, Cetuximab, Standard Dose Radiation, Low Dose Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Given as part of induction chemotherapy.
CarboplatinDrug
Given as part of induction chemotherapy.
CetuximabDrug
Given as part of induction chemotherapy.
Standard Dose RadiationRadiation
Radiation given once daily for 5 days for 7 weeks as part of CRT regimen.
Low Dose RadiationRadiation
Radiation given once daily for 5 days for 6.5 weeks as part of CRT regimen.
CisplatinDrug
Given as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
TFHX RegimenDrug
Also called paclitaxel, fluorouracil (5-FU), hydroxyurea
Chemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT.
| Study group | Role | What they receive |
|---|---|---|
| Induction Treatment Arm | Other | All participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab. Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Cetuximab |
| De-Escalation CRT Cohort | Experimental | After completing induction chemotherapy, participants that have significant disease response by imaging will receive low dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT. Receives: Radiation: Low Dose Radiation; Drug: Cisplatin; Drug: TFHX Regimen |
| Standard Treatment Cohort | Active comparator | After completing induction chemotherapy, participants that have limited disease response by imaging will receive standard dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT. Receives: Radiation: Standard Dose Radiation; Drug: Cisplatin; Drug: TFHX Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants that complete study treatment and provide all required research blood draws.
Measured: To be measured at end of treatment period (9 weeks)
Determine if ctDNA levels is predicative of disease response
Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.
Measured: To be measured at end of treatment period (9 weeks)
Secondary outcomes (2)
Number of participants with side effects related to study treatment
Measured: To be measured at 3 months after end of treatment period
Long Term Disease Response based on RECIST 1.1
Measured: To be assessed at 2 years after end of treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start18 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Negative Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ari Rosenberg, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005324
- Sponsor's protocol ID
- IRB23-0095
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Induction Therapy Followed by Response-adaptive Treatment and Dynamic Changes in Circulating Tumor DNA in Locoregionally Advanced HPV Negative Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06005324
- Acronym / sponsor ID
- IRB23-0095
- Conditions
- HPV-Negative Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will assess whether or not blood based biomarker testing can be used to personalize cancer treatment for patients with locally advanced head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Induction Treatment Arm | Other | Drug: Paclitaxel, Drug: Carboplatin, Drug: CetuximabAll participants will receive 3 cycles (9 weeks) of chemotherapy with paclitaxel, carboplatin, and cetuximab. |
| De-Escalation CRT Cohort | Experimental | Radiation: Low Dose Radiation, Drug: Cisplatin, Drug: TFHX RegimenAfter completing induction chemotherapy, participants that have significant disease response by imaging will receive low dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT. |
| Standard Treatment Cohort | Active comparator | Radiation: Standard Dose Radiation, Drug: Cisplatin, Drug: TFHX RegimenAfter completing induction chemotherapy, participants that have limited disease response by imaging will receive standard dose radiation treatment with additional chemotherapy (CRT). Investigator will choose the appropriate chemotherapy backbone to be given during CRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patients must have pathologically confirmed locally advanced, non-metastatic, human papillomavirus (HPV) negative head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.
- Stage III or IV disease based on American Joint Committee on Cancer (AJCC) staging 8th edition.
- If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry.
- Availability of ≥10 unstained 5 micron slides. Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.
- Patients must be at least 18 years of age.
Key exclusion criteria (13 listed)
- Unequivocal demonstration of distant metastatic disease (M1 disease).
- Unidentifiable primary site.
- Intercurrent medical illnesses which would impair patient tolerance to therapy or limit 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelGiven as part of induction chemotherapy. | Drug | Induction Treatment Arm |
| CarboplatinGiven as part of induction chemotherapy. | Drug | Induction Treatment Arm |
| CetuximabGiven as part of induction chemotherapy. | Drug | Induction Treatment Arm |
| Standard Dose RadiationRadiation given once daily for 5 days for 7 weeks as part of CRT regimen. | Radiation | Standard Treatment Cohort |
| Low Dose RadiationRadiation given once daily for 5 days for 6.5 weeks as part of CRT regimen. | Radiation | De-Escalation CRT Cohort |
| CisplatinGiven as part of CRT regimen (7 weekly doses). Investigator will choose the appropriate chemotherapy backbone to be given during CRT. | Drug | De-Escalation CRT Cohort, Standard Treatment Cohort |
| TFHX RegimenAlso: paclitaxel, fluorouracil (5-FU), hydroxyureaChemotherapy with paclitaxel, fluorouracil (5FU), and hydroxyurea given in combination with radiation therapy. Investigator will choose the appropriate chemotherapy backbone to be given during CRT. | Drug | De-Escalation CRT Cohort, Standard Treatment Cohort |
Primary outcome
Percentage of participants that complete study treatment and provide all required research blood draws.
Time frame: To be measured at end of treatment period (9 weeks)
Determine if ctDNA levels is predicative of disease response
Time frame: To be measured at end of treatment period (9 weeks)
Researchers will look at amount of ctDNA in the blood to determine if it correlates to disease response based on imaging results per RECIST v1.1.
2 secondary outcomes
Number of participants with side effects related to study treatment
Time frame: To be measured at 3 months after end of treatment period
Long Term Disease Response based on RECIST 1.1
Time frame: To be assessed at 2 years after end of treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari Rosenberg, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel, Carboplatin and Cetuximab in people with HPV-Negative Squamous Cell Carcinoma, 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 25 inclusion and 13 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 8 Jun 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Clinical 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?
Percentage of participants that complete study treatment and provide all required research blood draws. (time frame: To be measured at end of treatment period (9 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2025.