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Uterine Cervical NeoplasmsPhase 1/2NCT02866006

Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer

A Phase 1/2 study testing BVAC-C and Topotecan in people with Uterine Cervical Neoplasms, run by Cellid Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts. Phase I is for safety evaluation, and Phase IIa is for efficacy assessment. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
BVAC-C and Topotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
Oct 2016to Jun 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer
  • Patients has received 1 or more platinum based doublet chemotherapy as prior therapy for progressive or recurrent tumor lesion (prior therapy does not include platinum chemotherapy given with radiation therapy for 1st line treatment before progression or recurrence)
  • Patients with at least 1 measurable lesion according to RECIST
  • Female patients between ages of 20 to 70
  • Patients with ECOG performance status between 0 to 2
  • Patients meets the blood test standards in the screening test
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  • ANC≥1500/μL
  • LLN ≤ALC ≤ULN
  • Platelets≥100,000/μL
  • Hemoglobin> 9g/dL
  • Patients meets the blood chemistry test standards in the screening test
  • Serum creatinine ≤ 2.0 mg/dL
  • Calculated creatinine clearance ≥ 50 mL/min
  • Serum bilirubin ≤1.5 x ULN
  • ALT and AST ≤2.5 × ULN (≤ 5 x ULN in patients with liver metastases)
  • Patients who has agreed to a medically accepted contraceptive in this clinical trial
  • Patients at least three months or more of survival can be expected
  • Patients decided to participate in this clinical trial and signed written informed consent

Who cannot join

  • Patients histopathology is a neuroendocrine or small cell carcinoma
  • Patients with a history of brain metastasis or signs of brain metastasis
  • Patients tested positive in serological tests for hepatitis C virus or hepatitis B virus surface antigen, (HBsAg) or human immunodeficiency virus (HIV)
  • Patients with a history of HIV infection
  • Patients showing abnormal electrocardiogram , including arrhythmia
  • Patients have been administered the drug for other clinical trials within 4weeks before the screening visit
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  • Patients have been administered any vaccines within 4weeks before the screening visit (eg. hepatitis A, hepatitis B, influenza, Td, etc. )
  • Patients have been administered the blood products within 3 months before the screening visit
  • Patients have received chemotherapy or radiation therapy within 4weeks before the 1st administration of investigational drug (BVAC-C)
  • Patients treated with immunosuppressant or immunomodulatory agents within 6 months before the screening visit
  • Patients who have participated in the clinical trial of a therapeutic vaccine or immune therapy within 1 year before the screening visit
  • Patients with a history of serious allergic disease or serious side effects of the drug
  • Patients who is pregnant or breast-feeding
  • Patients researchers has determined that participation in the clinical trial is inappropriate
  • Patients suspected to have other primary cancer

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Open-label, Dose-escalation, Multiple Dosing Study to Evaluate the Safety, Tolerability, Immune Response and Pre Efficacy of BVAC-C in Patients With Multiple Metastatic Progressive or Recurrent HPV Type 16 or 18 Positive Cervical Cancer After Failure to Standard Care

BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts. Phase I is for safety evaluation, and Phase IIa is for efficacy assessment.

Read the detailed description

BVAC-C is an immunotherapeutic vaccine using B-Cell and Monocytes as antigen-presenting cells. This study is consists of 2 parts(Phase I, Phase II). Phase I study is Open-label, dose-escalation, multiple dosing study to evaluate the safety, tolerability, immune response and preliminary efficacy of BVAC-C in patients with multiple metastatic progressive or recurrent HPV type 16 or 18 positive cervical cancer after failure to standard care. 9~18 patients will be enrolled In Phase IIa study, which Open-label, sequential assignment multiple dosing study, efficacy, immune response and safety will be evaluated. Total 21 patients will be enrolled in 3 groups.

Being tested
BVAC-C, Topotecan
Keywords
HPV, Type 16, 18, E6E7, Immune therapeutic vaccine
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

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

  • BVAC-CDrug

    Autologous B cells and monocytes transfected with E6E7 gene of HPV

  • TopotecanDrug

Study groups in NCT02866006
Study groupRoleWhat they receive
BVAC-C mono(High dose)ExperimentalBVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)
Receives: Drug: BVAC-C
BVAC-C mono(Intermediate dose)ExperimentalBVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose)
Receives: Drug: BVAC-C
BVAC-C + Topo CombiExperimentalBVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks
Receives: Drug: BVAC-C; Drug: Topotecan

What is being measured

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

  1. Evaluate DLT with Clinical laboratory tests [Safety]

    Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay

    Measured: 12th week from first injection (End of trial)

  2. Incidence of Serious Adverse Events assessed with CTCAE [Safety]

    Measured: 12th week from first injection (End of trial)

Secondary outcomes (4)

  1. Clinical laboratory tests

    Blood chemistry, Serology

    Measured: Screening visit and every 2 weeks from first injection (up to 12th week)

  2. 12-lead ECG

    Measured: Screening visit and Termination visit (12th week from first injection)

  3. Vital signs

    Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature

    Measured: Every 2 weeks from first injection (up to 12th week)

  4. Physical examination

    Body weight

    Measured: Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)

Timeline

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

  1. First posted15 Aug 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2021
  4. Study completionJun 2022

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
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866006
Sponsor's protocol ID
BVAC-C-P1
Status last verified
Oct 2022
First submitted
9 Aug 2016
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Choi CH, Lee JW, Bae DS, Kang ES, Cho D, Kim YM, Kim K, Kim JW, Kim HS, Kim YT, Lee JY, Lim MC, Oh T, Song B, Jeon I, Park M, Kim WH, Kang CY, Kim BG. Efficacy and safety of BVAC-C in HPV type 16- or 18-positive cervical carcinoma who failed 1st platinum-based chemotherapy: a phase I/IIa study. Front Immunol. 2024 Mar 28;15:1371353. doi: 10.3389/fimmu.2024.1371353. eCollection 2024.

    PubMed 38605958

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BVAC-C and Topotecan in people with Uterine Cervical Neoplasms, run by Cellid Co., Ltd. at 1 site 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 18 inclusion and 15 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: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate DLT with Clinical laboratory tests [Safety] (time frame: 12th week from first injection (End of trial)). The study lists 2 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 NCT02866006, which also lists 1 linked publication.

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 12 Oct 2022.

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