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 is for safety evaluation, and Phase IIa is
for efficacy assessment.
Title
- Brief Title: Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
BVAC-C-P1
- NCT ID:
NCT02866006
Conditions
- Uterine Cervical Neoplasms
Interventions
| Drug | Synonyms | Arms |
|---|
| BVAC-C | | BVAC-C + Topo Combi |
| Topotecan | | BVAC-C + Topo Combi |
Purpose
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.
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BVAC-C mono(High dose) | Experimental | BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose) | |
| BVAC-C mono(Intermediate dose) | Experimental | BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose) | |
| BVAC-C + Topo Combi | Experimental | BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 20 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Evaluate DLT with Clinical laboratory tests [Safety] |
| Time Frame: | 12th week from first injection (End of trial) |
| Safety Issue: | |
| Description: | Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay |
Secondary Outcome Measures
| Measure: | Clinical laboratory tests |
| Time Frame: | Screening visit and every 2 weeks from first injection (up to 12th week) |
| Safety Issue: | |
| Description: | Blood chemistry, Serology |
| Measure: | 12-lead ECG |
| Time Frame: | Screening visit and Termination visit (12th week from first injection) |
| Safety Issue: | |
| Description: | |
| Measure: | Vital signs |
| Time Frame: | Every 2 weeks from first injection (up to 12th week) |
| Safety Issue: | |
| Description: | Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature |
| Measure: | Physical examination |
| Time Frame: | Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection) |
| Safety Issue: | |
| Description: | Body weight |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Cellid Co., Ltd. |
Trial Keywords
- HPV
- Type 16, 18
- E6E7
- Immune therapeutic vaccine
Last Updated
July 28, 2021
