Trial | NCT02866006  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bvac-c ...

  • Study Participants

    32
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.
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 Started
Oct 31
2016
Primary Completion
Dec 31
2021
Study Completion
Jun 30
2022
Last Update
Oct 12
2022

Drug BVAC-C

Autologous B cells and monocytes transfected with E6E7 gene of HPV

Drug Topotecan

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

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
No Results Posted