A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC. (NCT06797986) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects with HPV Positive HNSCC.
37 participantsStarted 2025-03
Plain-language summary
BVAC-E6E7 is an immunotherapeutic vaccine designed to treat unresectable recurrent or metastatic head and neck squamous cell carcinoma positive to HPV 16 or 18. This clinical trial for BVAC-E6E7 consists of two phases: PhaseⅠfocuses on safety and tolerance to determine the maximum tolerated dose (MTD), while Phase Ⅱ evaluates its efficacy.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male and female aged 19 and above at the time of acquisition informed consent form.
. Patients who have agreed to provide blood and tissue samples during the clinical trial.
. Patients with Head and neck squamous cell carcinoma histologically confirmed as HPV type 16 or 18 positive \* The biopsy results obtained during screening process or the genotyping (PCR, microarray test) results from stored tissue (formalin-fixed paraffin-embedded) prior to screening should be confirmed positive to HPV type 16 or 18.
. Patients who are histologically or cytologically diagnosed with recurrent/metastatic Head and neck squamous cell carcinoma (excluding Nasopharyngeal carcinoma).
. Patients with at least one measurable or evaluable lesion confirmed by CT or MRI according to RECIST v1.1. \[It can be considered as an evaluable lesion if the disease has progressed in the previously irradiated area.\]
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
[Part A] Incidence of dose-limiting toxicity (DLT) after BVAC-E6E7 administration
Timeframe: On day 1 of cycle 3 (each cycle is 21 days)
2
[Part B] Objective Response Rate (ORR)
Timeframe: During entire clinical trial, an average of 18 months.
3
[Part B] Disease Control Rate (DCR)
Timeframe: During entire clinical trial, an average of 18 months.
4
[Part B] Duration of Response (DOR)
Timeframe: From the date of objective response (CR or PR) to the date of disease progression or death, assessed up to 18 months.
. Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration.
. Patients with ECOG performance status of 0 or 1
. Patients with at least a 3-month life expectancy.
Exclusion criteria
. Patients with a history of malignant tumor, excluding Head and neck squamous cell carcinoma, within 3 years prior to the screening (However, patients who are judged by investigator to have been cured of Basal cell carcinoma (BCC) / Squamous cell carcinoma (SCC) of the skin, localized prostate cancer, papillary thyroid cancer, or cervical intraepithelial neoplasia (CIN) are able to enroll.)
. Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
. Patients having below cardiovascular disease at the time of the screening process.
. Patients who have confirmed clinically significant symptoms or uncontrolled central nervous system, brain metastasis, or carcinomatous meningitis (However, patients who have not confirmed the progression disease for at least 4 weeks after central nervous system or metastatic brain treatment and have not required treatment using steroid or other meditation within 7 days prior to the IP administration can be enrolled.)
. Patients with a history or confirmed active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, or T cell lymphoma) after receiving systemic treatment (e.g. disease-modifying agent, corticosteroid or immunosuppressive drug) \[However, alternative treatment (thyroxine, insulin, physiologic corticosteroid alternative treatment due to dysfunction of adrenal gland or pituitary gland) are not considered as systemic treatments.\]
. Patients who are unable to collect the blood for production of the IP, according to the judgement of investigator, due to thromboembolism disease or bleeding diatheses.
. Patients with a positive human immunodeficiency virus (HIV) test result
. Patients with active hepatitis B or C according to the hepatitis B virus (HBV) and hepatitis C virus (HCV) test result.