CompletedPhase 1/2

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

South Korea32 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

20 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 h…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate DLT with Clinical laboratory tests [Safety]

Timeframe: 12th week from first injection (End of trial)

Incidence of Serious Adverse Events assessed with CTCAE [Safety]

Timeframe: 12th week from first injection (End of trial)

Trial details

NCT IDNCT02866006

SponsorCellid Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12

View on ClinicalTrials.gov More Uterine Cervical Neoplasms trials