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

Primary Purpose

Uterine Cervical Neoplasms

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BVAC-C
Topotecan
Sponsored by
Cellid Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms focused on measuring HPV, Type 16, 18, E6E7, Immune therapeutic vaccine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BVAC-C mono(High dose)

BVAC-C mono(Intermediate dose)

BVAC-C + Topo Combi

Arm Description

BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)

BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose)

BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks

Outcomes

Primary Outcome Measures

Evaluate DLT with Clinical laboratory tests [Safety]
Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay
Incidence of Serious Adverse Events assessed with CTCAE [Safety]

Secondary Outcome Measures

Clinical laboratory tests
Blood chemistry, Serology
12-lead ECG
Vital signs
Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature
Physical examination
Body weight

Full Information

First Posted
August 9, 2016
Last Updated
October 10, 2022
Sponsor
Cellid Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02866006
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellid Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms
Keywords
HPV, Type 16, 18, E6E7, Immune therapeutic vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BVAC-C mono(High dose)
Arm Type
Experimental
Arm Description
BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)
Arm Title
BVAC-C mono(Intermediate dose)
Arm Type
Experimental
Arm Description
BVAC-C IV injection at 0, 4, 8, 12th weeks.(Half dose)
Arm Title
BVAC-C + Topo Combi
Arm Type
Experimental
Arm Description
BVAC-C IV injection at 0,4,8,12th weeks.(Half dose) Topotecan IV injection at 2, 6, 10, 14th weeks
Intervention Type
Drug
Intervention Name(s)
BVAC-C
Intervention Description
Autologous B cells and monocytes transfected with E6E7 gene of HPV
Intervention Type
Drug
Intervention Name(s)
Topotecan
Primary Outcome Measure Information:
Title
Evaluate DLT with Clinical laboratory tests [Safety]
Description
Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay
Time Frame
12th week from first injection (End of trial)
Title
Incidence of Serious Adverse Events assessed with CTCAE [Safety]
Time Frame
12th week from first injection (End of trial)
Secondary Outcome Measure Information:
Title
Clinical laboratory tests
Description
Blood chemistry, Serology
Time Frame
Screening visit and every 2 weeks from first injection (up to 12th week)
Title
12-lead ECG
Time Frame
Screening visit and Termination visit (12th week from first injection)
Title
Vital signs
Description
Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature
Time Frame
Every 2 weeks from first injection (up to 12th week)
Title
Physical examination
Description
Body weight
Time Frame
Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Y Kang, PH.D
Organizational Affiliation
Seoul National University
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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