Oropharyngeal Squamous Cell CarcinomaPhase 2NCT04852328
Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
A Phase 2 study testing CUE-101 in people with Oropharyngeal Squamous Cell Carcinoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- CUE-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 31 Oct 2027
- 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
- Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors.
- Stage I-III (AJCC 8th Edition) [except clinical stages T1N0 and T2N0, which are excluded from enrollment].
- A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision.
- HLA-A*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.
- Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor) and p16INK4A expression (>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.
- Have archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion of sufficient size and quality for eligibility determination.
Show all 18Show fewer
- At least 18 years of age.
- ECOG performance status ≤ 1.
- Normal bone marrow and organ function as defined below:
- Platelets ≥ 100,000/mcl
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,500/mcl
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Total bilirubin ≤ 1.5 x IULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin (total and direct) is within normal limits
- Creatinine < 1.5 mg/dL, or calculated or measured creatinine clearance >30 mL/min by Cockcroft-Gault
- Note: Screening laboratory tests may be repeated once within 7 days.
- The effects of CUE-101 on the developing human fetus are unknown. For this reason and because novel Fc Fusion Protein agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 30 days after completion of the study.
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Who cannot join
- History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
- Distant metastases.
- Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.
- Treatment with corticosteroids (>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. Corticosteroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 40 mg per day is allowed.
- History of clinically significant cardiovascular disease including:
- Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug
Show all 30Show fewer
- Clinically significant cardiac arrhythmias
- Uncontrolled hypertension: systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg
- Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug
- QTc prolongation > 480 msec
- Congestive heart failure (New York Heart Association class III- IV)
- Pericarditis/clinically significant pericardial effusion
- Myocarditis
- Clinically significant pulmonary compromise (eg, requirement for supplemental oxygen).
- Clinically significant gastrointestinal (GI) disorders including history of:
- GI perforation within 1 year prior to study drug administration;
- GI bleeding within 3 months prior to the initiation of study drug;
- Acute pancreatitis within 3 months prior to the initiation of study drug;
- Diverticulitis that is clinically significant in the opinion of the investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within 4 weeks prior to the initiation of study drug administration; and/or
- Cirrhosis.
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 1 week prior to the initiation of study drug.
- Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction. However, patients with treated hepatitis C in complete remission and off therapy for > 1 year are eligible.
- Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions include: non-melanoma skin cancer; cervical carcinoma in situ; squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); resected melanoma in situ; or favourable prognosis (<10% relapse risk) thyroid cancer.
- Prior treatment of the head and neck region with radiation therapy.
- History of major surgery within 4 weeks prior to the initiation of study drug administration. A diagnostic needle or excisional biopsy is not considered major surgery.
- Any serious underlying medical condition that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site.
- Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed. Vaccination for COVID-19 is allowed within one week prior to initiation of study drug administration.
- Active or recent history of uncontrolled alcohol or other substance abuse within 3 months prior to the initiation of study drug administration.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 72 hours of study entry.
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
Washington University School of Medicine
St Louis, Missouri, 63110
Jesse Zaretsky, M.D., 314-747-8244, jzaretsky@wustl.edu
Jesse Zaretsky, M.D.
About this study
Official title: Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
This is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Being tested
- CUE-101
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUE-101Drug
CUE Biopharma will supply CUE-101, which will be provided free of charge to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Schedule A: CUE-101 | Experimental | * In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy.
* Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) Receives: Drug: CUE-101 |
| Schedule B: CUE-101 | Experimental | * In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy.
* Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) Receives: Drug: CUE-101 |
| Schedule C: CUE-101 | Experimental | * In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy.
* Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) Receives: Drug: CUE-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-related adverse events
Measured: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
Number of adverse events
Measured: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
Treatment-related delays in start of standard of care therapy
-Defined as >7 days of treatment-related delay from the planned date of surgery or initiation of definitive-chemoradiation therapy.
Measured: From start of treatment through start of standard of care therapy (estimated to be 2 weeks)
Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samples
- Determined by IFN γ ELISpot for detection of HPV16 E711-20-specific T cells
- Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
Measured: Through 12 month follow-up
Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
- Determined by multiparameter flow cytometry
- Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
Measured: Through 12 month follow-up
Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samples
Measured: Baseline, day -2 or -1 before start of standard of care therapy
Activation markers of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Measured: Through 12 month follow-up
Proliferative status of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Measured: Through 12 month follow-up
Secondary outcomes (9)
Pathological tumor response
- Defined as rates of major and complete pathological response
- A major pathologic response (mPR) will be defined as ≤ 10% residual viable tumor within the tumor sample collected after administration of CUE-101. A complete pathologic response (cPR) will be defined as no invasive cancer in the tumor sample collected. For surgical patients, the tumor sample will include the primary tumor specimen and all sampled regional lymph nodes at the time of resection. For def-chemoradiation therapy patients, the tumor sample will comprise the biopsy(s) submitted. Pathologic tumor response will be stratified based on if the patients underwent surgery or post-CUE-101 biopsy only.
Measured: At the time of surgery or biopsy (Day 1 - approximately 7-14 days after start of CUE-101 treatment)
Objective response rate (ORR)
- Proportion of patients with a complete response + partial response
- Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Disappearance of all non-target lesions and normalization of tumor marker level.
- Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Prior to surgery/definitive chemoradiation treatment (Day 1 - approximately 7-14 after start of CUE-101 treatment)
Change in area under the concentration-time curve (AUC) of serum PK parameters
-Prior to each CUE-101 infusion, end of each CUE-101 infusion, 1 hour post-end of each CUE-101 infusion, 5 hours post-end of each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, surgery day 1 or definitive chemoradiation day -2 or -1, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up.
Measured: Through 12 month follow-up
Change in Cmax of serum PK parameters
-Prior to each CUE-101 infusion, end of each CUE-101 infusion, 1 hour post-end of each CUE-101 infusion, 5 hours post-end of each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, surgery day 1 or definitive chemoradiation day -2 or -1, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up.
Measured: Through 12 month follow-up
Change in Terminal elimination half-life(t1/2) of serum PK parameters
-Prior to each CUE-101 infusion, end of each CUE-101 infusion, 1 hour post-end of each CUE-101 infusion, 5 hours post-end of each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, surgery day 1 or definitive chemoradiation day -2 or -1, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up.
Measured: Through 12 month follow-up
Number of participants who relapse
Measured: Through 12 month follow-up
Number of participants who die summarized by cause of death
Measured: Through 12 month follow-up
Progression-free survival (PFS)
Measured: Through 12 month follow-up
Overall survival (OS)
Measured: Through 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start6 Dec 2021
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cue Biopharma
- Responsible party
- Sponsor
- Investigators
- Jesse Zaretsky, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852328
- Sponsor's protocol ID
- 202106015
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2021
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized Phase 2 Trial of Three Schedules of CUE-101 Administered Before Surgery or Definitive Chemoradiation Therapy in HLA-A*0201 Positive Patients With Locally Advanced, HPV16-Positive Oropharyngeal Squamous-Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04852328
- Acronym / sponsor ID
- 202106015
- Conditions
- Oropharyngeal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Cue Biopharma
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Apr 2021 (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 is a phase 2 trial to assess the safety and tolerability of three schedules of CUE-101 administered in the neoadjuvant phase before standard of care (SOC) therapy to treatment naïve, HLA-A*0201 positive patients with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma (OPSCC). This is an exploratory trial of a limited sample size to confirm safety and to assess for pharmacodynamic signals of efficacy in each of three schedules of CUE-101. Safety assessments will be performed at baseline and after CUE-101 administration. To assess for efficacy, peripheral blood and tumor samples will be collected at baseline and after CUE-101 administration. Following CUE-101, patients will proceed with SOC therapy, as prescribed by the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schedule A: CUE-101 | Experimental | Drug: CUE-101* In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
| Schedule B: CUE-101 | Experimental | Drug: CUE-101* In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
| Schedule C: CUE-101 | Experimental | Drug: CUE-101* In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a known primary site, but is suspected to be oropharynx based on clinical factors.
- Stage I-III (AJCC 8th Edition) [except clinical stages T1N0 and T2N0, which are excluded from enrollment].
- A candidate for standard of care therapy (either surgery followed by adjuvant therapy OR def-CRT), based on treating physician decision.
- HLA-A*0201 genotype as determined by genomic testing on blood sample performed at a CLIA-certified clinical or central laboratory.
- Tumors must test positive for HPV16 by PCR (performed on tumor) or ISH (performed in tumor) and p16INK4A expression (>70% staining in tumor cells) by IHC performed at a CLIA-certified clinical or central laboratory.
Key exclusion criteria (30 listed)
- History of prior allogeneic bone marrow, stem-cell or solid organ transplantation
- Distant metastases.
- Treatment with radiation therapy or systemic anti-cancer therapy prior to the initiation of study drug administration.
- Treatment with corticosteroids (>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration. Corticosteroids for topical, ophthalmic, inhaled, or nasal administration are allowed. Physiological replacement with hydrocortisone up to a maximum dose of 40 mg per day is allowed.
- History of clinically significant cardiovascular disease including:
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 |
|---|---|---|
| CUE-101CUE Biopharma will supply CUE-101, which will be provided free of charge to the patient. | Drug | Schedule A: CUE-101, Schedule B: CUE-101, Schedule C: CUE-101 |
Primary outcome
Number of treatment-related adverse events
Time frame: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
Number of adverse events
Time frame: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
Treatment-related delays in start of standard of care therapy
Time frame: From start of treatment through start of standard of care therapy (estimated to be 2 weeks)
-Defined as >7 days of treatment-related delay from the planned date of surgery or initiation of definitive-chemoradiation therapy.
Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samples
Time frame: Through 12 month follow-up
* Determined by IFN γ ELISpot for detection of HPV16 E711-20-specific T cells * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Time frame: Through 12 month follow-up
* Determined by multiparameter flow cytometry * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samples
Time frame: Baseline, day -2 or -1 before start of standard of care therapy
Activation markers of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Time frame: Through 12 month follow-up
Proliferative status of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Time frame: Through 12 month follow-up
9 secondary outcomes
Pathological tumor response
Time frame: At the time of surgery or biopsy (Day 1 - approximately 7-14 days after start of CUE-101 treatment)
Objective response rate (ORR)
Time frame: Prior to surgery/definitive chemoradiation treatment (Day 1 - approximately 7-14 after start of CUE-101 treatment)
Change in area under the concentration-time curve (AUC) of serum PK parameters
Time frame: Through 12 month follow-up
Change in Cmax of serum PK parameters
Time frame: Through 12 month follow-up
Change in Terminal elimination half-life(t1/2) of serum PK parameters
Time frame: Through 12 month follow-up
Number of participants who relapse
Time frame: Through 12 month follow-up
Number of participants who die summarized by cause of death
Time frame: Through 12 month follow-up
Progression-free survival (PFS)
Time frame: Through 12 month follow-up
Overall survival (OS)
Time frame: Through 12 month follow-up
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 20 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Jesse Zaretsky, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CUE-101 in people with Oropharyngeal Squamous Cell Carcinoma, run by Washington University School of Medicine 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 30 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 20 Jul 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 Jesse Zaretsky, M.D. (314-747-8244, jzaretsky@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treatment-related adverse events (time frame: From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)). The study lists 8 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 20 Jul 2026.