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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02866006
Recruitment Status : Active, not recruiting
First Posted : August 15, 2016
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Cellid Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: BVAC-C Drug: Topotecan Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: BVAC-C mono(High dose)
BVAC-C IV injection at 0, 4, 8th weeks.(HIgh dose)
Drug: BVAC-C
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)
Drug: BVAC-C
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
Drug: BVAC-C
Autologous B cells and monocytes transfected with E6E7 gene of HPV

Drug: Topotecan



Primary Outcome Measures :
  1. 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

  2. Incidence of Serious Adverse Events assessed with CTCAE [Safety] [ Time Frame: 12th week from first injection (End of trial) ]

Secondary Outcome Measures :
  1. Clinical laboratory tests [ Time Frame: Screening visit and every 2 weeks from first injection (up to 12th week) ]
    Blood chemistry, Serology

  2. 12-lead ECG [ Time Frame: Screening visit and Termination visit (12th week from first injection) ]
  3. Vital signs [ Time Frame: Every 2 weeks from first injection (up to 12th week) ]
    Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866006


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Cellid Co., Ltd.
Investigators
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Study Chair: C Y Kang, PH.D Seoul National University
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Responsible Party: Cellid Co., Ltd.
ClinicalTrials.gov Identifier: NCT02866006    
Other Study ID Numbers: BVAC-C-P1
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cellid Co., Ltd.:
HPV
Type 16, 18
E6E7
Immune therapeutic vaccine
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents