- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866006
Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
October 10, 2022 updated by: Cellid Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BVAC-C mono(High dose)
BVAC-C IV injection at 0, 4, 8th weeks.(HIgh
dose)
|
Autologous B cells and monocytes transfected with E6E7 gene of HPV
|
Experimental: BVAC-C mono(Intermediate dose)
BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half
dose)
|
Autologous B cells and monocytes transfected with E6E7 gene of HPV
|
Experimental: BVAC-C + Topo Combi
BVAC-C IV injection at 0,4,8,12th weeks.(Half
dose) Topotecan IV injection at 2, 6, 10, 14th weeks
|
Autologous B cells and monocytes transfected with E6E7 gene of HPV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate DLT with Clinical laboratory tests [Safety]
Time Frame: 12th week from first injection (End of trial)
|
Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay
|
12th week from first injection (End of trial)
|
Incidence of Serious Adverse Events assessed with CTCAE [Safety]
Time Frame: 12th week from first injection (End of trial)
|
12th week from first injection (End of trial)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical laboratory tests
Time Frame: Screening visit and every 2 weeks from first injection (up to 12th week)
|
Blood chemistry, Serology
|
Screening visit and every 2 weeks from first injection (up to 12th week)
|
12-lead ECG
Time Frame: Screening visit and Termination visit (12th week from first injection)
|
Screening visit and Termination visit (12th week from first injection)
|
|
Vital signs
Time Frame: Every 2 weeks from first injection (up to 12th week)
|
Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature
|
Every 2 weeks from first injection (up to 12th week)
|
Physical examination
Time Frame: Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)
|
Body weight
|
Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: C Y Kang, PH.D, Seoul National University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
August 9, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (Estimate)
August 15, 2016
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 10, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Topotecan
Other Study ID Numbers
- BVAC-C-P1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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