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New treatment option for Oropharyngeal Squamous Cell Carcinoma
Official title 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
What this study is testing
What is CUE-101?
CUE-101 is an investigational medicine, being studied as a potential treatment for oropharyngeal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of squamous-cell carcinoma of the oropharynx or of an upper (levels 2-3) neck mass without a...
- 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)...
You likely can't join if
- 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...
- History of clinically significant cardiovascular disease including:
- Myocardial infarction or unstable angina within the 16 weeks prior to the initiation of study drug
See the full eligibility criteria
Who can 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...
- 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 \ 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...
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.