NL-OMON55191RecruitingPhase 2
A phase II study to determine the efficacy and safety of Vvax001, a therapeutic Semliki Forest Virus based cancer vaccine, in patients with HPV-16 induced grade 3 cervical intraepithelial neoplasia. - Vvax001 cancer vaccine in HPV-16 related disease.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Adult female patients (>=18 years) who have newly been diagnosed with HPV-16
- •positive CIN3 lesions and have signed written informed consent according to
- •local guidelines. Patients of child-bearing potential should test negative
- •using a pregnancy test and agree to utilize effective contraception during the
- •entire treatment and follow-up period of the study.
Exclusion Criteria
- •* PAP5 lesions.
- •* Previously undergone treatment for CIN lesions.
- •* Adenocarcinoma in situ within CIN3 lesion
- •* History of autoimmune disease or other systemic intercurrent disease that
- •might affect the immunocompetence of the patient, or current or prior use (4
- •weeks before start of the study) of high dose immunosuppressive therapy.
- •* History of a malignancy except curatively treated low-stage tumors with a
- •histology that can be differentiated from the cervical cancer type.
- •* Participation in a study with another investigational drug within 30 days
- •prior to the enrolment in this study.
- •* Clinically significant findings as judged by the investigator on
- •screening/study entry including those from biochemistry, haematology and
- •urinalysis performed at screening.
- •* Any condition that in the opinion of the investigator could interfere with
- •the conduct of the study.
- •* Pregnancy.
Investigators
Similar Trials
Active, not recruiting
Phase 1
A phase II study investigating the efficacy and safety of Vvax001, a therapeutic cancer vaccine, in patients with premalignant cervical lesions.EUCTR2019-004050-29-NLniversity Medical Center Groningen18
Active, not recruiting
Phase 1
A Phase II Study to determine the efficacy and safety of conventional dose oral Treosulfan in patients with advanced pre-treated Ewing’s Sarcoma - OTISEUCTR2005-003254-10-GBniversity College London25
Active, not recruiting
Not Applicable
Phase II study to investigate the efficacy and safety of ZK 219477 as first-line therapy in chemotherapy naive patients with extensive disease (ED) stage small cell lung cancer (SCLC)Extensive disease (ED) stage small cell lung cancer (SCLC)EUCTR2005-000597-53-DESchering AG
Active, not recruiting
Not Applicable
Phase-II study to investigate the efficacy and safety of ZK 219477 as second-line therapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC)on small cell lung cancer (NSCLC) stage IIIB or stage IVEUCTR2005-000586-19-DEBayer Schering Pharma AG
Recruiting
Phase 2
A Phase2 study to investigate the efficacy and safety of Atezolizumab and bevacizumab with live bacterial product for unresectable HCCunresectable Hepatocellular carcinomaHepatocellular carcinomaJPRN-jRCTs031220724Tateishi Ryosuke44