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Cancer Vaccine
CUE-101 for Throat Cancer
Phase 2
Recruiting
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 12 month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment called CUE-101 to see if it is safe and effective for patients with a specific type of throat cancer. The treatment aims to boost the immune system before standard cancer therapy. Patients are newly diagnosed and have not yet received any other treatments.
Who is the study for?
This trial is for adults with newly diagnosed, locally advanced HPV16+ oropharyngeal squamous-cell carcinoma who are HLA-A*0201 positive. They should be able to undergo standard cancer treatments and have a good performance status (ECOG ≤ 1). Patients must not have had previous head and neck radiation, other cancers in the last two years (with some exceptions), or certain health conditions like uncontrolled hypertension or recent heart attacks.
What is being tested?
The trial is testing three different schedules of CUE-101 given before standard cancer treatments to see how safe it is and if it shows signs of working against the cancer. CUE-101 will be administered during the neoadjuvant phase, which means before main treatment starts. Researchers will collect blood and tumor samples to look for changes after giving CUE-101.
What are the potential side effects?
While specific side effects of CUE-101 aren't listed here, similar drugs can cause immune reactions, fatigue, digestive issues, skin reactions, and may affect liver function. Side effects depend on individual patient factors and dosing schedules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 12 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 12 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in frequency of HPV16 E711-20 tetramer-positive cytotoxic T cell lymphocytes
Change in frequency of HPV16 E711-20-specific CD8+ T cells in peripheral blood samples
Treatment-related delays in start of standard of care therapy
Secondary study objectives
Change in Cmax of serum PK parameters
Change in Terminal elimination half-life(t1/2) of serum PK parameters
Change in area under the concentration-time curve (AUC) of serum PK parameters
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Schedule C: CUE-101Experimental Treatment1 Intervention
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)
Group II: Schedule B: CUE-101Experimental Treatment1 Intervention
* 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)
Group III: Schedule A: CUE-101Experimental Treatment1 Intervention
* 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)
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,232 Total Patients Enrolled
Cue BiopharmaIndustry Sponsor
2 Previous Clinical Trials
137 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
12 Previous Clinical Trials
686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy on my head or neck before.I have a history of hepatitis B or C but have been in remission for over a year if treated.My cancer has spread to distant parts of my body.I haven't taken high-dose steroids or immune suppressants in the last 14 days.I have not started any cancer treatments before joining this study.I have not had serious heart or blood vessel problems recently.I haven't had major GI issues or liver disease recently.I haven't had serious infections needing IV treatment in the last week.I have had another cancer, but it's been in remission for over 2 years or falls under the exceptions.I have not had major surgery in the last 4 weeks.I haven't had any live virus vaccines in the last 4 weeks, except for flu and COVID-19 shots.I do not have any health conditions that would prevent me from receiving the study treatment.My cancer is confirmed to be squamous-cell carcinoma in the throat or upper neck.My cancer is stage I-III, but not the earliest stages of T1N0 or T2N0.My tumor is HPV16 positive and shows high p16 protein levels.My doctor has approved me for standard cancer treatment.I have a tumor tissue sample available for testing.My blood test shows I have the HLA-A*0201 genotype.I am 18 years old or older.I am fully active and can carry on all my pre-disease activities without restriction.My blood and organ tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Schedule B: CUE-101
- Group 2: Schedule C: CUE-101
- Group 3: Schedule A: CUE-101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.