NL-OMON49404已完成不适用
Ovarian cancer treatment with a liposome formulated mRNA Vaccine in combination with (neo-)adjuvant chemotherapy - OLIVIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
Trial ended prematurely
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 epithelial OC patients with measurable tumor lesions (determined by
- •CT or MRI), who are intended to be treated with neo-adjuvant chemotherapy,
- •carboplatin/paclitaxel, subsequent surgery and adjuvant chemotherapy
- •- Age >= 18 years
- •- Signed informed consent in accordance with institutional and regulatory
- •- Adequate access of the tumor for image-guided biopsy
- •- Adequate (according to the institutional standards) hematology, liver and
- •kidney function to undergo chemotherapy with carboplatin and paclitaxel
- •- ECOG-performance status of 0 or 1 at screening
- •- Current BMI > 18.5 and no weight loss of >5% over the past month. Notably,
- •weight loss due to drainage of ascites is not applicable.
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.
- •- Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or
- •p.o. >7.5 mg / day).
- •- Pregnancy or breast feeding
- •- 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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