Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Ce… (NCT02866006) | Clinical Trial Compass
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 range20 Years
SexFEMALE
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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…
What they're measuring
1
Evaluate DLT with Clinical laboratory tests [Safety]
Timeframe: 12th week from first injection (End of trial)
2
Incidence of Serious Adverse Events assessed with CTCAE [Safety]
Timeframe: 12th week from first injection (End of trial)