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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title CUE-101with Pembrolizumab for Locally Advanced HPV+HNSCCs
ClinicalTrials.gov ID: NCT07172256
What this study is testing
What is CUE-101?
CUE-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck 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, pilot, randomized, open-label 3-arm study to assess the safety, tolerability, and efficacy of CUE-101 monotherapy, and CUE-101 in combination with pembrolizumab as neoadjuvant therapy in HLA-A\ 0201-positive treatment naive participants with locally advanced HPV-16 associated head and neck squamous cell carcinoma (HNSCC).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell...
- Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons:
- Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)
- Risk of significant functional deficit with a surgical treatment approach
- Other anatomical (such as retropharyngeal location of the carotid artery) or tumor characteristics that in the surgeon's judgment would be a...
You likely can't join if
- Has distant metastases or radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or...
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. If the urine test is positive or cannot be...
- Participants who received prior radiotherapy treatment or systemic anticancer therapy including any other investigational agents for the HNC under...
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior...
- History of allergic reactions attributed to compounds of similar chemical or biologic. composition to recombinant proteins, polysorbate 80 or any...
- Participants with any history of known or suspected autoimmune disease with the specific exceptions of the following:
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0)
- Participants must be deemed unresectable by a head and neck surgeon for one or more of the following reasons:
- Inability to obtain a R0 resection with a minimally invasive surgical approach, such as Transoral Robotic Surgery (TORS)
- Risk of significant functional deficit with a surgical treatment approach
- Other anatomical (such as retropharyngeal location of the carotid artery) or tumor characteristics that in the surgeon's judgment would be a contra-indication to a minimally invasive surgical approach.
- Participants with newly diagnosed HNSCC who underwent partial surgical resection and have gross residual disease are eligible for the study if additional treatment is required.
- Participant must have a tumor that is HPV-16 positive and express p16INK4A. Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and/or surgery must be available for HPV-16 and p16INK4A...
- Archival tissue or formalin fixed, paraffin-embedded (FFPE) tissue from a biopsy and/or surgery must be available for PD-L1 staining. Tumors must be scored for CPS.
- Participants must have HLA-A\ 0201 genotype as determined by genomic testing.
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal...
- Age ≥18 years. Since no dosing or adverse event data are currently available on the use of CUE-101 alone or in combination with pembrolizumab in participants \<18 years of age, children are excluded from this study.
- ECOG performance status of 0 or 1 (Karnofsky ≥60%, see Appendix A).
- Participants must have adequate organ and marrow function as defined below in the protocol
- Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- A male participant must agree to use of a highly effective method of contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this...
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal or
- A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- Highly effective methods of contraception: i. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal. ii. Progestogen-only...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Has distant metastases or radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator and...
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In such...
- Participants who received prior radiotherapy treatment or systemic anticancer therapy including any other investigational agents for the HNC under study prior to first dose of study drug.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug.
- History of allergic reactions attributed to compounds of similar chemical or biologic. composition to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-101 or pembrolizumab.
- Participants with any history of known or suspected autoimmune disease with the specific exceptions of the following:
- Vitiligo.
- Resolved childhood atopic dermatitis.
- Psoriasis (with exception of psoriatic arthritis) not requiring systemic treatment (within the past 2 years).
- Participants with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
- History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
- Treatment with corticosteroids (\>10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 7 days prior to the first dose of study drug administration. Steroids for topical, ophthalmic...
- 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 (BP) \> 180 mmHg, diastolic BP \>100 mmHg.
- Deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack within the 16 weeks prior to the initiation of study drug.
- QTcB prolongation \> 480 msec.
- Congestive heart failure (New York heart Association class III-IV).
- Pericarditis/clinically significant pericardial effusion.
- Myocarditis.
- Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen)
- Clinically significant GI disorders including:
- History of GI perforation within 1 year prior to study drug administration. Participants with a history of GI perforation that occurred more than 1 year ago can only be enrolled if the sponsor-investigator no longer...
- History of clinically significant GI bleeding within 3 months prior to the initiation of study drug.
- History of acute pancreatitis within 3 months prior to the initiation of study drug.
- Diverticulitis that is clinically significant in the opinion of the sponsor-investigator based on the extent or severity of known disease and/or the occurrence of clinically significant disease flares within four weeks...
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within seven days prior to the initiation of study drug. Participants requiring any systemic antiviral, antifungal, or...
- Second primary invasive malignancy that has not been in remission for \> 2 years. Exceptions that do not require a 2-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy; or squamous...
- History of trauma or major surgery within 4 weeks prior to first dose of study drug.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Has Grade \> 2 audiometric hearing loss. Note: Audiometric abnormalities without corresponding clinical symptoms of Grade \> 2 hearing loss will not be grounds for exclusion.
- Has Grade \> 2 neuropathy.
- Has Grade \> 2 bleeding due to the underlying malignancy.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Active or history of alcohol or other substance abuse within 1 year prior to the initiation of study drug administration.
- Participants with uncontrolled intercurrent illness.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements, as determined by the treating investigator.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or...
- Any investigative site personnel directly affiliated with this study.
- Prisoners or other individuals who are involuntarily detained.
- Pregnant women are excluded from this study because it is unknown whether CUE-101 and/or pembrolizumab is an agent with the potential for teratogenic or abortifacient effects. It is unknown whether pembrolizumab is...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.