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Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 1/2NCT06797986

A Phase I/IIa Clinical Trial to Investigate BVAC-E6E7 in Subjects With HPV Positive HNSCC.

A Phase 1/2 study testing BVAC-E6E7 (low level), BVAC-E6E7 (high level) and BVAC-E6E7 (RP2D) in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HPV (Human Papillomavirus)-Associated Carcinoma, run by Cellid Co., Ltd. at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
BVAC-E6E7 (low level), BVAC-E6E7 (high level) and BVAC-E6E7 (RP2D)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesSouth Korea
Study dates
4 Feb 2026to Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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.]
  • Patients who meet one of the following criteria and have no available standard treatment due to contraindication, intolerance or refusal of administration.
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  • ① Patients who have progressed or recurred the cancer during or after the completion of primary or subsequent platinum based palliative systemic chemotherapy to treat the recurrent or metastatic Head and neck cancer.
  • ② Patients who have confirmed the progression of cancer within 24 weeks after the final administration of immune checkpoint blocker (ICI) or completion of combination treatment including platinum agents with a radical purpose.
  • ③ Patients who are ineligible for platinum based chemotherapy due to contraindications, intolerance or refusal of administration of platinum based chemotherapy.
  • 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 completion of IP administration.
  • Appropriate contraceptive method: absolute abstinence, hormone contraceptive agent with unknown drug-interaction (e.g. levonorgestrel intrauterine system (IUS) (Mirena) or Medroxyprogesterone) and surgical sterilization operation (Vasectomy, Bilateral salpingectomy and ligation, etc.). However, Intermittent abstinences (ovulation period, symptothermal method or late-ovulation) or Coitus interruptus are not considered as appropriate contraceptive method.

Who cannot join

  • 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.
  • 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.
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  • 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.
  • 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 toxicities. (excluding Alopecia and vitiligo), even after 4 weeks, are not eligible for enrollment.]
  • 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 not allowed.)
  • 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 eligible for enrollment.]
  • ① Patients who have participated in a clinical trial of immune therapeutic vaccine within 1 year before the screening or in an immunotherapy clinical trial within 6 weeks before the screening.
  • ② Patients with adverse drug reaction of Grade 2 or higher clearly associated with a previously participated immunotherapy clinical trial.
  • Patients who are not eligible to enroll in this clinical trial according to the judgement of investigator for any other reason.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wu Hyun Kim, D.V.M contact

02-3285-7863

whkim@cellid.co.kr

South Korea2 sites, 2 recruiting

  • Seoul National Univesity Hospital

    Seoul

    Recruiting

  • Sevrance Hospital

    Seoul

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase I/IIa Clinical Trial to Investigate the Safety, Immunogenicity and Efficacy of BVAC-E6E7 in Subjects With HPV Type 16 and/or 18 Positive Unresectable Recurrent or Metastatic Head

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.

Being tested
BVAC-E6E7 (low level), BVAC-E6E7 (high level), BVAC-E6E7 (RP2D)
Keywords
HNSCC, BVAC-E6E7, HPV Type 16 and/or 18 Positive
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BVAC-E6E7 (low level)Biological

    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.

  • BVAC-E6E7 (high level)Biological

    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.

  • BVAC-E6E7 (RP2D)Biological

    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.

Study groups in NCT06797986
Study groupRoleWhat they receive
BVAC-E6E7 (low level)ExperimentalPart A (low level) Test group will receive low dose level (2.5 x 10^7 cells/dose) of BVAC-E6E7 for every 3 weeks, 6 times by IV injection
Receives: Biological: BVAC-E6E7 (low level)
BVAC-E6E7 (high level)ExperimentalPart A (high level) Test group will receive high dose level (5.0 x 10^7 cells/dose) of BVAC-E6E7 for every 3 weeks, 6 times by IV injection
Receives: Biological: BVAC-E6E7 (high level)
BVAC-E6E7 (RP2D)ExperimentalPart B Test group will receive RP2D of BVAC-E6E7 for every 3 weeks, 6 times by IV injection
Receives: Biological: BVAC-E6E7 (RP2D)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Part A] Incidence of dose-limiting toxicity (DLT) after BVAC-E6E7 administration

    The DLT assessment criteria are based on NCI-CTCAE v5.0. The assessment includes individual criteria for hematologic/non-hematologic toxicities and other toxicities.

    DLT (dose-limiting toxicity) is defined as adverse events or abnormal laboratory values that limit the IP's dose-escalation and are not related to disease progression or intercurrent disease.

    Measured: On day 1 of cycle 3 (each cycle is 21 days)

  2. [Part B] Objective Response Rate (ORR)

    The ratio of subjects assessed with complete response (CR) or partial response (PR) as a best overall response.

    Measured: During entire clinical trial, an average of 18 months.

  3. [Part B] Disease Control Rate (DCR)

    The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.

    Measured: During entire clinical trial, an average of 18 months.

  4. [Part B] Duration of Response (DOR)

    Duration from objective response (CR or PR) to disease progression or death in subjects assessed with CR or PR as a best overall response.

    Measured: From the date of objective response (CR or PR) to the date of disease progression or death, assessed up to 18 months.

  5. [Part B] 6-month Progression Free Survival rate (PFS rate) or PFS

    6-month PFS rate is defined as the ratio of subjects assessed with no disease progression or death at 6 months after the first IP administration.

    PFS is defined as the duration until disease progression or death in subjects from the first IP administration.

    Measured: 6-month after the first IP administration for 6-month PFS / From first IP administration to disease progression or death for PFS

  6. [Part B] 12-month Overall Survival rate (OS rate) or OS

    12-month OS rate is defined as the survival rate at 12-month after the first IP administration.

    OS is defined as the duration until death in subjects from the first IP administration.

    Measured: 12-month after the first IP administration for 12-month OS rate / From first IP administration to death for OS

Secondary outcomes (14)

  1. [Part A] Objective Response Rate (ORR)

    The ratio of subjects assessed with complete response (CR) or partial response (PR) as a best overall response.

    Measured: During entire clinical trial, an average of 18 months.

  2. [Part A] Disease Control Rate (DCR)

    The ratio of subjects assessed with CR or PR or stable disease (SD) as a best overall response.

    Measured: During entire clinical trial, an average of 18 months.

  3. [Part A] Duration of Response (DOR)

    Duration from objective response (CR or PR) to disease progression or death in subjects assessed with CR or PR as a best overall response.

    Measured: From objective response (CR or PR) to disease progression or death, assessed up to 18 months.

  4. [Part A] 6-month Progression Free Survival rate (PFS rate) or PFS

    6-month PFS rate is defined as the ratio of subjects assessed with disease progression or death at 6 months after the first IP administration.

    PFS is defined as the duration until disease progression or death in subjects from the first IP administration.

    Measured: 6-month after the first IP administration for 6-month PFS rate / From first IP administration to disease progression or death for PFS

  5. [Part A] 12-month Overall Survival rate (OS rate) or OS

    12-month OS rate is defined as the survival rate at 12-month after the first IP administration.

    OS is defined as the duration until death in subjects from the first IP administration.

    Measured: 12-month after the first IP administration for 12-month OS rate / From first IP administration to death for OS

  6. [Part A/B] Adverse event

    Every adverse event collected from the entire clinical trial is categorized by severity, causality, treatment, or outcome of each adverse event.

    Measured: During entire clinical trial, an average of 18 months.

  7. [Part A/B] A number of subjects demonstrating abnormal CS in clinical laboratory test

    Clinical laboratory test including hematology, blood chemistry, urinalysis, virus test (only at screening visit).

    Measured: At screening visit, day 1 of every cycle, day 2 of cycle 6 (each cycle is 21 days).

  8. [Part A/B] A number of subjects demonstrating abnormal CS in vital sign

    Vital sign including measure blood pressure, pulse rate, and body temperature

    Measured: At screening visit and every visit from the first IP administration day, assessed up to 18 months.

  9. [Part A/B] A number of subjects demonstrating abnormal CS in physical examination

    The physical examination including examination of the appearance, skin, head/neck, chest/lungs, heart, abdomen, genitourinary/reproductive system, extremities, musculoskeletal system, nervous system, lymph nodes, and other organ.

    Measured: At screening visit, day 1 of cycle 1, Day 2 of Cycle 6 (each cycle is 21 days). If necessary, it can be conducted according to judgement of investigator at other visits from the first IP administration day, assessed up to 18 months.

  10. [Part A/B] A number of subjects demonstrating abnormal CS in 12-lead ECG

    Measured: At screening visit, day 2 of cycle 6 (1 cycle is 21 days). If necessary, it can be conducted at other visits after first IP administration day until day 1 of cycle 6.

  11. [Part A/B] Detection of E6E7 recombinant gene

    Assesses whether the E6E7 recombinant gene is detected in peripheral blood by BVAC-E6E7 monitoring

    Measured: At screening visit, day 1 of cycle 1 and day 2 of every cycle (each cycle is 21 days).

  12. [Part A/B] T cell response

    Spot Forming Units (SFU) counts

    Measured: At day 1 of cycle 1, day 2 of every cycle, and week 24, 42, 60 after first IP administration (each cycle is 21 days).

  13. [Part A/B] Cytokines in the blood

    Concentration changes of IFN-γ, TNF-α, IL-4

    Measured: At day 1 of cycle 1, day 2 of every cycle (each cycle is 21 days).

  14. [Part A/B] Concentration changes of tumor infiltrating lymphocyte (TIL) in lesion

    Measured: (optional) at screening visit, day 2 of cycle 6 (each cycle is 21 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start4 Feb 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797986
Sponsor's protocol ID
VIVACE-001
Status last verified
Jul 2026
First submitted
20 Nov 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BVAC-E6E7 (low level), BVAC-E6E7 (high level) and BVAC-E6E7 (RP2D) in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HPV (Human Papillomavirus)-Associated Carcinoma, run by Cellid Co., Ltd. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wu Hyun Kim, D.V.M (02-3285-7863, whkim@cellid.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Part A] Incidence of dose-limiting toxicity (DLT) after BVAC-E6E7 administration (time frame: On day 1 of cycle 3 (each cycle is 21 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06797986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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Clinical Trial NCT06797986 | AzTrials