Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
Eligibility Criteria
Inclusion Criteria:
- Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
- Has just completed primary debulking surgery or is eligible for primary debulking surgery or is a potential candidate for interval debulking surgery
- Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the adjuvant or neoadjuvant setting
- Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125) (kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
- Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor markers status prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to initiating chemotherapy in the lead-in period and within 3 days prior to Day 1 of Cycle 1
- Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Has adequate organ function
Exclusion Criteria:
- Has mucinous, germ cell, or borderline tumor of the ovary
- Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
- Has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
- Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
- Has a known additional malignancy that is progressing or has required active treatment in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded.
- Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the lead-in period
- Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to randomization. Stable brain metastases should be established prior to the first dose of study medication lead-in chemotherapy
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a known history of active tuberculosis (TB; Bacillus Tuberculosis)
- Has an active infection requiring systemic therapy
- Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in period
- Is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
- Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer <6 months prior to screening
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Testing for hepatitis B or hepatitis C is required at screening only if mandated by local health authority. Note: Participants with a history of hepatitis B but who are HBsAg negative are eligible for the study
- Is either unable to swallow orally administered medication or has a gastrointestinal (GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, malabsorption)
- Has uncontrolled hypertension
- Has current, clinically relevant bowel obstruction (including sub-occlusive disease), abdominal fistula or GI perforation, related to underlying EOC (for participants receiving bevacizumab)
- Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to randomization (for participants receiving bevacizumab)
- Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle 1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study, starting with screening through 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy
- Has received prior treatment for any stage of OC, including radiation or systemic anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy, investigational therapy)
- Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40, CD137)
- Has received prior therapy with either olaparib or any other poly(adenosine-ribose) polymerase (PARP) inhibitor
- Has intraperitoneal chemotherapy planned or has been administered as first-line therapy
- Has received a live vaccine within 30 days prior to the first dose of study treatment on Day 1 of Cycle 1
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin, paclitaxel or bevacizumab (if using) and/or any of their excipients
- Is currently receiving either strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
- Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
- Has received whole blood transfusions in the last 120 days prior to randomization
- Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks (28 days) of starting chemotherapy in the Lead-in Period
- Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions or participant has congenital long QT syndrome
- Has had an allogenic tissue/solid organ transplant, has received previous allogenic bone-marrow transplant, or has received double umbilical cord transplantation
- Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery
Sites / Locations
- University of Alabama at Birmingham (UAB) ( Site 0036)
- University of Arizona Cancer Center ( Site 0074)
- Disney Family Cancer Center ( Site 0042)
- Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)
- Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)
- Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)
- Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)
- Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)
- Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)
- Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)
- Smilow Cancer Center at Yale-New Haven ( Site 0057)
- Sarasota Memorial Hospital ( Site 0023)
- Emory School of Medicine ( Site 0053)
- Northeast Georgia Medical Center ( Site 0029)
- Memorial Health University Medical Center ( Site 0011)
- Rush University Medical Center ( Site 0019)
- University of Chicago ( Site 0049)
- Dr. Sudarshan K. Sharma, LTD ( Site 0061)
- Saint Vincent Hospital and Health Center ( Site 0012)
- University of Iowa Hospital and Clinics ( Site 0005)
- University of Kentucky ( Site 0045)
- Weinberg Cancer Institute at Franklin Square ( Site 0035)
- Saint Dominic - Jackson Memorial Hospital ( Site 0072)
- Washington University - School of Medicine ( Site 0062)
- Nebraska Methodist Hospital ( Site 0063)
- Dartmouth Hitchcock Medical Center ( Site 0024)
- MD Anderson Cancer Center at Cooper ( Site 0067)
- Holy Name Medical Center ( Site 0037)
- Northwell Health- Monter Cancer Center ( Site 0075)
- Sanford Roger Maris Cancer Center ( Site 0082)
- Miami Valley Hospital [Dayton, OH] ( Site 0073)
- Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)
- The Bing Cancer Center ( Site 0044)
- OSU Wexner Medical Center ( Site 0076)
- Women and Infants Hospital [Providence, RI] ( Site 0039)
- Sanford Gynecology Oncology ( Site 0004)
- Texas Oncology, P.A. - Bedford ( Site 8005)
- Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)
- Parkland Hospital ( Site 0081)
- UT Southwestern Medical Center ( Site 0046)
- Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)
- Virginia Cancer Specialists, PC ( Site 8003)
- MEDICAL COLLEGE OF WISCONSIN ( Site 0064)
- St George Hospital ( Site 2207)
- Cairns and Hinterland Hospital and Health Service ( Site 2201)
- Ballarat Health Services ( Site 2202)
- Monash Health ( Site 2204)
- Sunshine Hospital. ( Site 2205)
- Imelda Ziekenhuis Bonheiden ( Site 0301)
- UZ Leuven Campus Gasthuisberg ( Site 0306)
- Cliniques Universitaires Saint-Luc ( Site 0312)
- Grand Hopital de Charleroi ( Site 0302)
- CHU de Liege ( Site 0310)
- Jessa Ziekenhuis ( Site 0309)
- Centre Hospitalier de l'Ardenne ( Site 0303)
- AZ Maria Middelares Gent ( Site 0300)
- UZ Gent ( Site 0307)
- Instituto do Cancer do Ceara ( Site 2707)
- Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)
- Hospital Erasto Gaertner ( Site 2716)
- Hospital de Caridade de Ijui ( Site 2712)
- Hospital Bruno Born ( Site 2704)
- Hospital Nossa Senhora Da Conceicao ( Site 2703)
- Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)
- Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)
- Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
- Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)
- Tom Baker Cancer Centre ( Site 0200)
- Kingston Health Sciences Centre ( Site 0207)
- The Credit Valley Hospital ( Site 0206)
- Princess Margaret Hospital.. ( Site 0202)
- CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)
- CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)
- Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)
- Royal Victoria Hospital McGill University Health Centre ( Site 0211)
- Centro Investigación del Cáncer James Lind ( Site 2810)
- Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)
- Fundacion Arturo Lopez Perez FALP ( Site 2800)
- Sociedad Oncovida S.A. ( Site 2807)
- Iram Cancer Research ( Site 2809)
- Pontificia Universidad Catolica de Chile ( Site 2805)
- Oncocentro ( Site 2801)
- Centro Oncologico Antofagasta ( Site 2804)
- Biomelab S A S ( Site 2900)
- Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)
- Oncomedica S.A. ( Site 2911)
- Instituto Nacional de Cancerologia E.S.E ( Site 2910)
- Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)
- Centro Medico Imbanaco de Cali S.A ( Site 2909)
- Hemato Oncologos S.A. ( Site 2906)
- Fakultni nemocnice Brno ( Site 0404)
- Fakultni nemocnice Ostrava ( Site 0403)
- Vseobecna fakultni nemocnice v Praze ( Site 0400)
- Nemocnice Na Bulovce ( Site 0401)
- Fakultni nemocnice Olomouc ( Site 0402)
- Hopital Prive Jean Mermoz ( Site 0607)
- Centre Paul Strauss ( Site 0615)
- Hopital de la Timone ( Site 0617)
- CHU de Brest -Site Hopital Morvan ( Site 0616)
- Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)
- Institut de Cancerologie Lucien Neuwirth ( Site 0613)
- Centre D Oncologie de Gentilly ( Site 0609)
- Institut Gustave Roussy ( Site 0600)
- Hopital Tenon ( Site 0612)
- Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)
- Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)
- Uniklinik RWTH Aachen ( Site 0718)
- Gynaekologisches Zentrum ( Site 0712)
- Klinikum Dortmund gGmbH ( Site 0717)
- Universitaetsklinikum Duesseldorf ( Site 0704)
- HELIOS Klinikum Krefeld ( Site 0715)
- Universitaetsklinikum Muenster ( Site 0720)
- Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)
- Klinikum Chemnitz gGmbH ( Site 0711)
- Staedtisches Krankenhaus Kiel GmbH ( Site 0709)
- Charite Campus Virchow-Klinikum - CVK ( Site 0700)
- Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)
- Orszagos Onkologiai Intezet ( Site 0800)
- Uzsoki Utcai Korhaz ( Site 0803)
- Debreceni Egyetem Klinikai Kozpont ( Site 0801)
- Soroka Medical Center ( Site 1006)
- Hillel Yaffe Medical Center ( Site 1011)
- Carmel Medical Center ( Site 1007)
- Rambam Medical Center ( Site 1002)
- Edith Wolfson Medical Center ( Site 1003)
- Shaare Zedek Medical Center ( Site 1005)
- Rabin Medical Center ( Site 1004)
- Chaim Sheba Medical Center ( Site 1000)
- Sourasky Medical Center ( Site 1001)
- IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)
- Istituto Europeo di Oncologia ( Site 1100)
- A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)
- Istituto Oncologico Veneto IRCCS ( Site 1113)
- Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)
- Ospedale Cannizzaro ( Site 1110)
- ASST Lecco. Ospedale A. Manzoni ( Site 1101)
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)
- A.O.U. Federico II di Napoli ( Site 1107)
- Azienda Ospedaliera Policlinico Umberto I ( Site 1111)
- Policlinico Universitario Gemelli ( Site 1105)
- Presidio Ospedaliero Santa Chiara ( Site 1109)
- A.O. Univ. S. M. della Misericordia ( Site 1114)
- National Cancer Center Hospital East ( Site 2602)
- National Hospital Organization Shikoku Cancer Center ( Site 2601)
- Ehime University Hospital ( Site 2600)
- Gunma Prefectural Cancer Center ( Site 2609)
- Hokkaido University Hospital ( Site 2607)
- Iwate Medical University Hospital ( Site 2606)
- St. Marianna University School of Medicine Hospital ( Site 2613)
- University of the Ryukyus Hospital ( Site 2616)
- Saitama Medical University International Medical Center ( Site 2604)
- Saitama Cancer Center ( Site 2614)
- National Defense Medical College Hospital ( Site 2608)
- Kyorin University Hospital ( Site 2610)
- Kagoshima City Hospital ( Site 2612)
- Niigata Cancer Center Hospital ( Site 2618)
- Osaka International Cancer Institute ( Site 2617)
- National Cancer Center Hospital ( Site 2605)
- Seoul National University Bundang Hospital ( Site 2404)
- Seoul National University Hospital ( Site 2403)
- Severance Hospital Yonsei University Health System ( Site 2400)
- Asan Medical Center ( Site 2402)
- Samsung Medical Center ( Site 2401)
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
- Bialostockie Centrum Onkologii ( Site 1412)
- Szpitale Pomorskie Sp. z o.o. ( Site 1407)
- Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)
- Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)
- Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
- Arkhangelsk Clinical Oncological Dispensary ( Site 1508)
- Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
- A. Tsyb Medical Radiological Research Center ( Site 1513)
- FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)
- FSCC of Special Types of Med. Care and Technologies ( Site 1503)
- Medical Rehabilitation Center ( Site 1502)
- City Clinical Oncology Center ( Site 1505)
- National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)
- Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
- Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)
- Groote Schuur Hospital ( Site 1704)
- Wits Clinical Research ( Site 1702)
- Department of Medical Oncology ( Site 1703)
- Curo Oncology ( Site 1710)
- Wilgers Oncology Centre ( Site 1705)
- Little Company of Mary Hospital ( Site 1700)
- Sandton Oncology Medical Group PTY LTD ( Site 1712)
- The Oncology Centre ( Site 1709)
- Cancercare ( Site 1706)
- Outeniqua Cancercare Oncology Unit ( Site 1708)
- Cape Town Oncology Trials Pty Ltd ( Site 1707)
- Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)
- Xarxa Assistencial Universitaria Manresa ( Site 1605)
- Hospital de Terrassa ( Site 1606)
- Hospital Universitario de Donostia ( Site 1602)
- Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)
- Instituto Valenciano de Oncologia ( Site 1601)
- Hospital General Universitario de Valencia ( Site 1610)
- Hospital Provincial San Pedro de Alcantara ( Site 1607)
- Hospital Universitario Lucus Augusti ( Site 1609)
- Clinica Universitaria de Navarra ( Site 1600)
- Hospital Universitario Virgen del Rocio ( Site 1604)
- Changhua Christian Hospital ( Site 2507)
- China Medical University Hospital ( Site 2506)
- Taichung Veterans General Hospital ( Site 2510)
- National Cheng Kung University Hospital ( Site 2508)
- National Taiwan University Hospital ( Site 2502)
- MacKay Memorial Hospital ( Site 2500)
- Taipei Veterans General Hospital ( Site 2503)
- Linkou Chang Gung Memorial Hospital ( Site 2501)
- Istanbul Acibadem University Atakent Hospital ( Site 1902)
- Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)
- Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)
- Akdeniz Universitesi Tıp Fakultesi ( Site 1901)
- Uludag Universitesi Tip Fakultesi ( Site 1904)
- Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)
- Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)
- Medipol Universite Hastanesi ( Site 1909)
- Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)
- MI Precarpathian Clinical Oncology Center ( Site 2181)
- Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)
- Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli
- Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)
- MI Odessa Regional Oncological Centre ( Site 2121)
- RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)
- Central City Clinical Hospital ( Site 2150)
- Kyiv City Clinical Oncological Center ( Site 2140)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Pembrolizumab + Olaparib
Pembrolizumab + Placebo for Olaparib
Placebo for Pembrolizumab + Placebo for Olaparib
Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.
Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.