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New treatment option for Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.
ClinicalTrials.gov ID: NCT06797986
What this study is testing
What is BVAC-E6E7 (low level)?
BVAC-E6E7 (low level) is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc).
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
- 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.
- 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 19 and older
You may be able to join if
- 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...
- Patients who are histologically or cytologically diagnosed with recurrent/metastatic Head and neck squamous cell carcinoma (excluding Nasopharyngeal...
- 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...
You likely can't join if
- Patients with a history of malignant tumor, excluding Head and neck squamous cell carcinoma, within 3 years prior to the screening (However, patients...
- Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
- Patients having below cardiovascular disease at the time of the screening process. ① Myocardial infarction or Unstable angina within 6 months prior...
- Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).
- Ventricular arrhythmia requiring treatment. ④ Severe conduction disorder (e.g. 3rd degree AV block) ⑤ Uncontrolled hypertension according to the...
- Patients who have confirmed clinically significant symptoms or uncontrolled central nervous system, brain metastasis, or carcinomatous meningitis...
See the full eligibility criteria
Who can join
- 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...
- 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.]
- Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration. ① Patients who have progressed or recurred the cancer during or...
- Patients with ECOG performance status of 0 or 1
- Patients with at least a 3-month life expectancy.
- Male patients who has not received the vasectomy should agree usage barrier contraceptive method (i.e. condom) and agree to use appropriate contraception for themselves and their partners for at least 6 months after the...
- Appropriate contraceptive method: absolute abstinence, hormone contraceptive agent with unknown drug-interaction (e.g. levonorgestrel intrauterine system (IUS) (Mirena) or Medroxyprogesterone) and surgical sterilization...
What rules you out
- 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...
- Nasopharyngeal cancer or Head and neck cancer other than squamous cell carcinoma.
- Patients having below cardiovascular disease at the time of the screening process. ① Myocardial infarction or Unstable angina within 6 months prior to the first IP administration (baseline).
- Severe heart failure or congestive heart failure of class Ⅲ or higher according to the New York Heart Association (NYHA).
- Ventricular arrhythmia requiring treatment. ④ Severe conduction disorder (e.g. 3rd degree AV block) ⑤ Uncontrolled hypertension according to the judgement by investigator.
- 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...
- 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...
- 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. ① Patients positive for HBsAg and HBV DNA. ② Patients positive for anti-HCV and HCV RNA.
- Patients with autoimmune disease or history of chronic or recurrent autoimmune diseases.
- Patients with a history of organ transplantation.
- Hematopoietic stem cell transplantation (HSCT) patients.
- Patients who have confirmed severe or uncontrolled active inflammation within 12 weeks prior to screening process.
- Patients with a history of hypersensitivity to the components of IP.
- Patients who have administrated a leukocyte product within 12 weeks prior to screening process.
- Patients who have received chemotherapy, radiotherapy or targeted therapy within 4 weeks prior to baseline [However, patients who have not recovered to NCI-CTCAE v5.0 Grade 1 or baseline levels from chemotherapy-related...
- Patients who have administrated live-vaccine or live attenuated vaccine within 4 weeks prior to baseline.
- Patients who have administrated immunosuppressant within 2 weeks prior to baseline. (However, usage corresponding to the following immunosuppressant is allowed.)
- Steroid for nasal cavity, aspiration, topical, or local site (e.g. Intra-articular injection)
- Prednisolone 10 mg/day or systemic corticosteroid at a physiologic dose that does not exceed the equivalent amount.
- Steroids used for pretreatment of hypersensitivity (e.g. pretreatment of CT)
- Patients who meet the following laboratory test standards in the screening test
- ANC \< 1,500/mm³
- Platelet count \< 75,000/mm³
- Hemoglobin \< 9.0 g/dL (If the hemoglobin recovers above 9.0g/dL during the screening period, the patient is eligible for enrollment. However, blood transfusions within 7 days before screening to meet that standard is...
- Serum creatinine \>1.5 × ULN
- Total bilirubin \>1.5 × ULN
- AST or ALT \>2.5 × ULN (If liver metastasis confirmed \>5 × ULN)
- Pregnant or lactating women
- Patients who have administrated IP for other clinical trials or applied investigational device within 4 weeks before screening. [However, the patients who correspond to one of the following, even after 4 weeks, are not...
- Patients who are not eligible to enroll in this clinical trial according to the judgement of investigator for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.