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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02866006
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cellid Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 9, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date July 18, 2018
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • 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
  • Incidence of Serious Adverse Events assessed with CTCAE [Safety] [ Time Frame: 12th week from first injection (End of trial) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02866006 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • Clinical laboratory tests [ Time Frame: Screening visit and every 2 weeks from first injection (up to 12th week) ]
    Blood chemistry, Serology
  • 12-lead ECG [ Time Frame: Screening visit and Termination visit (12th week from first injection) ]
  • Vital signs [ Time Frame: Every 2 weeks from first injection (up to 12th week) ]
    Blood pressure, Pulse rate, Respiratory rate, Tympanic temperature
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uterine Cervical Neoplasms
Intervention  ICMJE Drug: BVAC-C
BVAC-C IV injection at 0, 4, 8th weeks.
Study Arms  ICMJE Experimental: BVAC-C
BVAC-C IV injection at 0, 4, 8th weeks.
Intervention: Drug: BVAC-C
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2016)
9
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wu Hyun Kim, DVM +82-2-3285-7861 whkim@cellid.co.kr
Contact: T G Oh, PH.D +82-2-3285-7861 whkim@cellid.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866006
Other Study ID Numbers  ICMJE BVAC-C-P1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cellid Co., Ltd.
Study Sponsor  ICMJE Cellid Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: C Y Kang, PH.D Seoul National University
PRS Account Cellid Co., Ltd.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP