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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 from start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months
Awards & highlights
Study Summary
This trial is testing a new drug, CUE-101, to see if it is safe and effective in treating patients with a certain type of throat cancer.
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.Check my eligibility
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.See study design
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 ~ from start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Change in frequency of HPV16 E711-20-specific CD8+ T cells in tumor samples
+3 moreSecondary outcome measures
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 moreTrial 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)
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,672 Total Patients Enrolled
Cue BiopharmaIndustry Sponsor
2 Previous Clinical Trials
137 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
11 Previous Clinical Trials
533 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 A: CUE-101
- Group 2: Schedule C: CUE-101
- Group 3: Schedule B: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are there in this clinical trial?
"That is correct, the online information indicates that this research study is still recruiting patients. The 30 participants needed for the trial will be recruited from a single site and the study was originally posted on December 6th, 2021 with the most recent update being September 7th, 2022."
Answered by AI
What are the main goals of this clinical trial?
"The primary outcome of this clinical trial, which will be evaluated over approximately From start of treatment through 12 months after the completion of standard of care treatment (estimated to be 15 months) is to Number of adverse events. Secondary outcomes include Pathological tumor response which is defined as Defined as rates of major and complete pathological responseA 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"
Answered by AI
What is the FDA's opinion of CUE-101?
"CUE-101's safety was estimated to be a 2. In other words, while there is some data supporting CUE-101's safety, none of it suggests that the medication is effective."
Answered by AI
Are researchers currently looking for participants for this trial?
"Yes, the information available on clinicaltrials.gov shows that this particular trial is looking for enrollees at this time. This specific trial was first posted December 6th, 2021 and has been updated September 7th, 2022. The study requires 30 patients total between 1 location."
Answered by AI
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