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

NCT02866006 | Completed Phase 1

• 1 other identifier: BVAC-C-P1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evaluate DLT with Clinical laboratory tests [Safety]

  Lymphocyte subset, Serum cytokine, NKT/NK cell assay, CD4/CD8 assay

  12th week from first injection (End of trial)

• Incidence of Serious Adverse Events assessed with CTCAE [Safety]

  12th week from first injection (End of trial)

Secondary Outcomes (4)

• Clinical laboratory tests

  Screening visit and every 2 weeks from first injection (up to 12th week)

• 12-lead ECG

  Screening visit and Termination visit (12th week from first injection)

• Vital signs

  Every 2 weeks from first injection (up to 12th week)

• Physical examination

  Screening, 6th week from first injection, 10th week from first injection and Termination visit (12th week from first injection)

Study Arms (3)

BVAC-C mono(High dose)

EXPERIMENTAL

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

Drug: BVAC-C

BVAC-C mono(Intermediate dose)

EXPERIMENTAL

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

Drug: BVAC-C

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

Drug: BVAC-C; Drug: Topotecan

Interventions

BVAC-C DRUG

Autologous B cells and monocytes transfected with E6E7 gene of HPV

BVAC-C + Topo Combi; BVAC-C mono(High dose); BVAC-C mono(Intermediate dose)

Topotecan DRUG

BVAC-C + Topo Combi

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cellid Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Choi CH, Lee JW, Bae DS, Kang ES, Cho D, Kim YM, Kim K, Kim JW, Kim HS, Kim YT, Lee JY, Lim MC, Oh T, Song B, Jeon I, Park M, Kim WH, Kang CY, Kim BG. Efficacy and safety of BVAC-C in HPV type 16- or 18-positive cervical carcinoma who failed 1st platinum-based chemotherapy: a phase I/IIa study. Front Immunol. 2024 Mar 28;15:1371353. doi: 10.3389/fimmu.2024.1371353. eCollection 2024.

  PMID: 38605958 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• C Y Kang, PH.D

  Seoul National University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 15, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

KR (1)