Clinical Trials /

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

NCT02866006

Description:

BVAC-C is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is 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. 9~18 patients will be enrolled

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
BVAC-CBVAC-C

Purpose

BVAC-C is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is 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. 9~18 patients will be enrolled

Trial Arms

NameTypeDescriptionInterventions
BVAC-CExperimentalBVAC-C IV injection at 0, 4, 8th weeks.
  • BVAC-C

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:70 Years
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
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cellid Co., Ltd.

Trial Keywords

  • HPV
  • Type 16, 18
  • E6E7
  • Immune therapeutic vaccine

Last Updated