The FIRST (First-line ovarian cancer treatment with Niraparib plus TSR-042) Study
- Conditions
- Stage 3 or 4 Non-mucinous Epithelial Ovarian CancerMedDRA version: 21.1Level: PTClassification code: 10070907Term: Ovarian cancer stage III Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10070908Term: Ovarian cancer stage IV Class: 100000004864Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-510605-28-00
- Lead Sponsor
- Tesaro Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1655
1. Patients must be female, =18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent., 10. Patients must have an ECOG score of 0 or 1, 11. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension (systolic BP =140 mmHg and/or diastolic BP =90 mmHg), 12. Patients must agree to complete HRQoL questionnaires throughout the study, 13. Patients must be able to take oral medication, 2. Patients with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the FIGO or tumor, node and metastasis staging criteria [ie, American Joint Committee on Cancer], 3. All patients with Stage IV disease are eligible. This includes those with inoperable disease, those who undergo PDS (R0 or macroscopic disease), or those for whom NACT is planned, 4. Patients with Stage III are eligible if they meet one or more of the following criteria: a. Stage IIIC patients CC0 resection if they meet the following criteria: aggregate = 5 cm extra-pelvic disease during PDS as assessed by the Investigator. b. All patients with inoperable Stage III disease. c. All Stage III patients with macroscopic residual tumor (per Investigator judgment) following PDS. d. All Stage III patients for whom NACT is planned, 5. Patient must provide a blood sample for ctDNA HRR testing at PreScreening or Screening, 6. Patient must provide sufficient tumor tissue sample (a minimum of 1 FFPE block or slide at Pre-Screening or Screening) for PD-L1, homologous recombination deficiency (HRD) testing, 7. Patients of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin) within 3 days prior to receiving the first dose of study treatment, 8. Patients must be postmenopausal, free from menses for >1 year, surgically sterilized, or willing to use highly effective contraception to prevent pregnancy or must agree to abstain from activities that could result in pregnancy throughout the study, starting with enrollment through 180 days after the last dose of study treatment, 9. Patients must have adequate organ function, defined as follows (Note: CBC test should be obtained without transfusion or receipt of stimulating factors within 2 weeks before obtaining Screening blood sample): a. Absolute neutrophil count =1,500/µL b. Platelet count =100,000/µL c. Hemoglobin =9 g/dL d. Serum creatinine =1.5 × upper limit of normal (ULN) or calculated creatinine clearance =60 mL/min using the Cockcroft Gault equation e. Total bilirubin =1.5 × ULN or direct bilirubin =1.5 × ULN f. Aspartate aminotransferase and alanine aminotransferase (ALT) =2.5 × ULN unless liver metastases are present, in which case they must be =5 ×
1. Patient has mucinous, germ cell, transitional cell, or undifferentiated tumor, 10. Patient initiating bevacizumab as SOC has proteinuria as demonstrated by urine protein:creatinine ratio =1.0 at Screening or urine dipstick for proteinuria =2 (patients discovered to have =2 proteinuria on dipstick at baseline should undergo a 24 hour urine collection and must demonstrate <2 g of protein in 24 hours to be eligible), 11. Patient has any known history or current diagnosis of MDS or AML, 12. 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 I endometrial cancer, or nonmelanomatous skin cancer are allowed, 13. 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)., 14. Patient is immunocompromised. Patients with splenectomy are allowed. Patients with known HIV are allowed if they meet all criteria as listed in the protocol, 15. Patient has known active hepatitis B (eg, hepatitis B surface antigen reactive) or hepatitis C (eg, hepatitis C virus ribonucleic acid [qualitative] is detected), 16. Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, non malignant systemic disease, or uncontrolled infection, 17. 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, 18. 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, 19. Patient has a known contraindication or uncontrolled hypersensitivity to the components of paclitaxel, carboplatin, niraparib, bevacizumab, dostarlimab, or their excipients, 2. Patient has low grade or Grade 1 epithelial ovarian cancer, 20. Prior treatment for high-grade nonmucinous epithelial ovarian, fallopian tube, or peritoneal cancer (immunotherapy, anticancer therapy, radiation therapy), 21. Patient has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (eg, thyroid hormone or insulin), 22. Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment, 3. Stage III patient with R0 resection after PDS (ie, no macroscopic residual disease, unless inclusion criterion #4a is met), 4. Patient has not adequately recovered from prior major surgery, 5. 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, 6. Patient is pregnant or is expecting to conceive children
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method