Is NCT04852328 recruiting in St Louis, MO?

Yes, NCT04852328 is currently recruiting participants at its St Louis, MO location. This oropharyngeal squamous cell carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this St Louis clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Oropharyngeal Squamous Cell Carcinoma Clinical Trial in St Louis, MO

Q: How do I join the oropharyngeal squamous cell carcinoma clinical trial in St Louis?

To join this clinical trial in St Louis, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Oropharyngeal Squamous Cell Carcinoma Study in St Louis

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.

Sponsor: Washington University School of Medicine

Who Can Participate

Inclusion Criteria

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.

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.

Exclusion Criteria

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

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

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in St Louis?

Yes, this clinical trial (NCT04852328) has an active research site in St Louis, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Oropharyngeal Squamous Cell Carcinoma Treatment Options in St Louis, MO

If you're searching for oropharyngeal squamous cell carcinoma treatment options in St Louis, MO, this clinical trial (NCT04852328) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our St Louis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced oropharyngeal squamous cell carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all oropharyngeal squamous cell carcinoma clinical trials near you to find additional studies recruiting in your area.

Oropharyngeal Squamous Cell Carcinoma Clinical Trial in St Louis, MO

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