| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
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| CRITÈRES D'EXCLUSION |
(EN)
- Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor.
- Patient has low-grade or Grade 1 epithelial ovarian cancer.
- Stage III patient with complete cytoreduction (CC0) resection after primary debulking surgery (ie, no macroscopic residual disease, unless the patient has aggregate 5 cm extra-pelvic disease during primary debulking surgery.
- Patient has not adequately recovered from prior major surgery.
- Patient has a known condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment in the opinion of the Investigator.
- Patient has been diagnosed and/or treated with any therapy for invasive cancer <5 years from study enrollment, completed adjuvant chemotherapy and/or targeted therapy (eg, trastuzumab) less than 3 years from enrollment, or completed adjuvant hormonal therapy less than 4 weeks from enrollment. Patients with definitively treated non-invasive malignancies such as cervical carcinoma in situ, ductal carcinoma in situ, Grade 1 or 2, Stage IA endometrial cancer, or non-melanomatous skin cancer are allowed.
- Patient is at increased bleeding risk due to concurrent conditions (eg, major injuries or major surgery within the past 28 days prior to start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
- Patient is immunocompromised. Patients with splenectomy are allowed. Patients with well-controlled known human immunodeficiency virus (HIV) are allowed.
- Patient has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected).
- Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection.
- Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
- Patient has received a live vaccine within 14 days of planned start of study therapy. Seasonal influenza vaccines that do not contain live viruses are allowed.
- Patient has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, TSR-042, or their excipients.
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