this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.
Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer.
Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery.
Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits/L) : carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 [Vergote, I., et al 2010].
Absolute neutrophil count (ANC) ≥1500/μL
Participant has mucinous, germ cell, or borderline tumor of the ovary.
Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years.
Single group
Carboplatin
Drugneoadjuvant treatment , followed by surgery, then maintenance chemotherapy
olaparibp, embro
Drugmaintenance chemotherapy : olaparib, pembro
Progression free survival
Progression free survival at 36 month according to Response Evaluation Criteria in Solid tumors RECIST 1.1
Progression free survival at 12 months
To assess progression free survival at 12 months according to RECIST v1.1
Progression free survival at 24 months
To assess progression free survival at 24 months according to RECIST v1.1
pathological complete response (pCR)
To assess pathological complete response (pCR) at the time of interval debulking surgery after 3 cycles of therapy
overall survival (OS)
To assess overall survival (OS) at 36 months
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University of Alabama at Birmingham
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
