NL-OMON55212已完成不适用
An open label, phase 1 study to evaluate the safety, feasibility and immunogenicity of an allogeneic, cell-based vaccine (DCP-001) in high grade serous ovarian cancer patients after primary treatment - ALISO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Primary HGSOC patients (FIGO stage 3B to IV) who completed primary treatment
- •defined as:
- •o primary debulking surgery (complete / optimal) and 6 cycles of adjuvant
- •chemotherapy (carboplatin/paclitaxel)
- •o 3 cycles of neo-adjuvant chemotherapy (more NACT cycles to improve
- •surgical outcome are allowed) followed by interval debulking surgery (complete
- •/ optimal) and 3 cycles of adjuvant chemotherapy (carboplatin/paclitaxel)
- •- Decreased CA125 compared to pre-treatment CA125
- •- Serum level CA125 < 100 kU/L
- •- Age >= 18 years
- •- Signed informed consent form (ICF) in accordance with institutional and
- •regulatory guidelines
排除标准
- •- History of a second malignancy except for curatively treated low-stage tumors
- •with a histology that can be differentiated from the epithelial OC type
- •- Patients must have no ongoing or recent evidence (within the last 5 years) of
- •significant autoimmune disease that required treatment with systemic
- •immunosuppressive treatments which may suggest risk for immune-related adverse
- •events (irAEs).
- •Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related
- •hypothyroidism who are in remission, or on a stable dose of thyroid-replacement
- •hormone, vitiligo, or psoriasis may be included.
- •- Patients must have no uncontrolled infection with human immunodeficiency
- •virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency
- •that is related to, or results in chronic infection. Mild cancer-related
- •immunodeficiency (such as immunodeficiency treated with gamma globulin and
- •without chronic or recurrent infection) is allowed.
- •o Patients with known HIV who have controlled infection (undetectable viral
- •load and CD4 count above 350 either spontaneously or on a stable antiviral
- •regimen) are permitted. For patients with controlled HIV infection, monitoring
- •will be performed per local standards.
- •o Patients with known hepatitis B (HepBsAg+) who have controlled infection
- •(serum hepatitis B virus DNA PCR that is below the limit of detection AND
- •receiving antiviral therapy for hepatitis B) are permitted. Patients with
- •controlled infections must undergo periodic monitoring of HBV DNA per local
- •standards. Patients must remain on anti-viral therapy for at least 6 months
- •beyond the last dose of trial treatment.
- •o Patients who are known hepatitis C virus antibody positive (HCV Ab+) who
- •have controlled infection (undetectable HCV RNA by PCR either spontaneously or
- •in response to a successful prior course of anti-HCV therapy) are permitted.
- •- Liver or renal function abnormalities that are considered to be clinically
- •relevant by the investigator.
- •- Abnormal blood levels (neutropenia among other things) due to chemotherapy
- •that are considered to be clinically relevant by the investigator.
- •o If so, blood levels will be repeated in 1-2 weeks, in case blood levels
- •are normalized the patient is allowed to be included in the study. In case of
- •persistent abnormal blood levels the patient will be excluded.
- •- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
- •p.o. >7.5 mg / day).
- •- Participation in a trial with another investigational drug within 30 days
- •prior to the enrolment in this trial
- •- Any condition that in the opinion of the investigator could interfere with
- •the conduct of the trial.
研究者
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