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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)

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo for pembrolizumab
Carboplatin
Paclitaxel
Olaparib
Placebo for olaparib
Bevacizumab
Docetaxel
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pembrolizumab + Olaparib

Pembrolizumab + Placebo for Olaparib

Placebo for Pembrolizumab + Placebo for Olaparib

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10)
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS≥10) tumors.
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.

Secondary Outcome Measures

Overall Survival (OS) in All Participants
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
OS in Participants with PDL-1 Positive Tumors (CPS ≥ 10)
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants with PD-L1 positive tumors (CPS≥10).
PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants with PD-L1-Positive Tumors (CPS≥10)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for participants with PD-L1-positive (CPS≥10) tumors.
PFS Per RECIST 1.1 as Assessed by BICR in All Participants
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for all participants.
PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants with PD-L1-Positive Tumors (CPS≥10)
PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for participants with PD-L1-positive (CPS≥10) tumors.
PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for all participants.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Mean Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. The mean change from baseline in GHS/QoL score of participants will be reported.
Mean Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. The mean change from baseline in abdominal/GI symptom score of participants will be reported.
Time to deterioration (TTD) of GHS/QoL score using EORTC QLQ-C30
Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as ≥10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported.
Time to deterioration (TTD) of abdominal/GI symptoms using EORTC QLQ-OV28
Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. TTD is defined as the time from the first EORTC QLQ-OV28 assessment to deterioration (defined as ≥10-point decrease in EORTC QLQ-OV28 score from baseline) or death, whichever occurs first. The TTD in abdominal/GI symptom score of participants will be reported.
Time to First Subsequent Anti-cancer Treatment (TFST)
TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST will be reported.
Time to Second Subsequent Anti-cancer Treatment (TSST)
TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST will be reported.
Time to Discontinuation of Study Treatment or Death (TDT)
TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT will be reported.
Pathological Complete Response (pCR) Rate
pCR is defined as all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The pCR rate for all surgical specimens will be reported.

Full Information

First Posted
November 12, 2018
Last Updated
September 6, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT03740165
Brief Title
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)
Official Title
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.
Detailed Description
Following a lead-in period during which all participants receive a single 3-week cycle of carboplatin/paclitaxel*, participants will be randomly assigned in to one of three treatment arms: Pembrolizumab + Olaparib, Pembrolizumab + Placebo for Olaparib Placebo for Pembrolizumab + Placebo for Olaparib At Investigator's discretion and prior to participant randomization, one of the following carboplatin/paclitaxel regimens is to be selected: up to 5 cycles of carboplatin Area Under the Curve (AUC)5 or AUC6 AND paclitaxel 175 mg/m^2 on Day 1 of each 3-week cycle up to 5 cycles of carboplatin AUC5 or AUC6 on Day 1 of each 3-week cycle AND paclitaxel 80 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle; or up to 5 cycles of carboplatin AUC2 or AUC2.7 AND paclitaxel 60 mg/m^2 on Days 1, 8 and 15 of each 3-week cycle. Docetaxel may be considered for participants who experience either a severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel only after consultation with the Sponsor. The recommended dose as determined by the Scottish Gynaecological Cancer Trials Group is Docetaxel 75 mg/m^2 Q3W plus carboplatin AUC 5 Q3W.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Olaparib
Arm Type
Experimental
Arm Description
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.
Arm Title
Pembrolizumab + Placebo for Olaparib
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo for Pembrolizumab + Placebo for Olaparib
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo for pembrolizumab
Other Intervention Name(s)
normal saline or dextrose
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Olaparib
Other Intervention Name(s)
MK-7339, LYNPARZA®
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for olaparib
Intervention Description
Oral tablet
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
AVASTIN®
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10)
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for participants with PD-L1-positive (CPS≥10) tumors.
Time Frame
Up to approximately 57 months
Title
PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants.
Time Frame
Up to approximately 57 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in All Participants
Description
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
Time Frame
Up to approximately 6 years
Title
OS in Participants with PDL-1 Positive Tumors (CPS ≥ 10)
Description
OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants with PD-L1 positive tumors (CPS≥10).
Time Frame
Up to approximately 6 years
Title
PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) in Participants with PD-L1-Positive Tumors (CPS≥10)
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for participants with PD-L1-positive (CPS≥10) tumors.
Time Frame
Up to approximately 57 months
Title
PFS Per RECIST 1.1 as Assessed by BICR in All Participants
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review will be reported for all participants.
Time Frame
Up to approximately 57 months
Title
PFS After Second-line Treatment (PFS2) Following Discontinuation of Study Treatment as Assessed by the Investigator in Participants with PD-L1-Positive Tumors (CPS≥10)
Description
PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for participants with PD-L1-positive (CPS≥10) tumors.
Time Frame
Up to approximately 78 months
Title
PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
Description
PFS2 is defined as the time from randomization until PD (clinical or radiological) after second-line treatment or death due to any cause, whichever occurs first. The PFS2 per Investigator assessment will be reported for all participants.
Time Frame
Up to approximately 78 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time Frame
Up to approximately 73 months
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time Frame
Up to approximately 6 years
Title
Mean Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Description
Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. The mean change from baseline in GHS/QoL score of participants will be reported.
Time Frame
Baseline and End of Study Participation (Up to approximately 6 years)
Title
Mean Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
Description
Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. The mean change from baseline in abdominal/GI symptom score of participants will be reported.
Time Frame
Baseline and End of Study Participation (Up to approximately 6 years)
Title
Time to deterioration (TTD) of GHS/QoL score using EORTC QLQ-C30
Description
Participants are asked to answer 2 questions from the EORTC QLQ-C30 about their GHS: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" Responses are based on a 7-point scale (1=Very poor; 7=Excellent), with a higher score indicating a better global health status. TTD is defined as the time from the first GHS/QoL assessment to deterioration (defined as ≥10-point decrease in GHS/QoL score from baseline) or death, whichever occurs first. The TTD in GHS/QoL score of participants will be reported.
Time Frame
Up to approximately 6 years
Title
Time to deterioration (TTD) of abdominal/GI symptoms using EORTC QLQ-OV28
Description
Participants are asked to answer 6 questions from the EORTC QoL Questionnaire-Ovarian Cancer (QLQ-OV28) abdominal/GI symptom scale about abdominal pain, bloated feeling in abdomen/stomach, changes in clothing fit, changes in bowel habit, flatulence and stomach fullness when eating. Responses are based on a 4-point scale (1=Not at all; 4=Very much), with a lower score indicating better abdominal/GI symptoms. TTD is defined as the time from the first EORTC QLQ-OV28 assessment to deterioration (defined as ≥10-point decrease in EORTC QLQ-OV28 score from baseline) or death, whichever occurs first. The TTD in abdominal/GI symptom score of participants will be reported.
Time Frame
Up to approximately 6 years
Title
Time to First Subsequent Anti-cancer Treatment (TFST)
Description
TFST is defined as the time from randomization to initiation of first subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TFST will be reported.
Time Frame
Up to approximately 6 years
Title
Time to Second Subsequent Anti-cancer Treatment (TSST)
Description
TSST is defined as the time from randomization to initiation of second subsequent anti-cancer treatment or death due to any cause, whichever occurs first. The TSST will be reported.
Time Frame
Up to approximately 6 years
Title
Time to Discontinuation of Study Treatment or Death (TDT)
Description
TDT is defined as the time from the date of randomization to discontinuation of study treatment or death due to any cause, whichever occurs first. The TDT will be reported.
Time Frame
Up to approximately 6 years
Title
Pathological Complete Response (pCR) Rate
Description
pCR is defined as all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The pCR rate for all surgical specimens will be reported.
Time Frame
Up to approximately 30 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham (UAB) ( Site 0036)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arizona Cancer Center ( Site 0074)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Disney Family Cancer Center ( Site 0042)
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)
City
Sacramento
State/Province
California
ZIP/Postal Code
95814
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Smilow Cancer Center at Yale-New Haven ( Site 0057)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Sarasota Memorial Hospital ( Site 0023)
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory School of Medicine ( Site 0053)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northeast Georgia Medical Center ( Site 0029)
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Memorial Health University Medical Center ( Site 0011)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Rush University Medical Center ( Site 0019)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago ( Site 0049)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dr. Sudarshan K. Sharma, LTD ( Site 0061)
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Saint Vincent Hospital and Health Center ( Site 0012)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospital and Clinics ( Site 0005)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky ( Site 0045)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Weinberg Cancer Institute at Franklin Square ( Site 0035)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Saint Dominic - Jackson Memorial Hospital ( Site 0072)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University - School of Medicine ( Site 0062)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Methodist Hospital ( Site 0063)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center ( Site 0024)
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
MD Anderson Cancer Center at Cooper ( Site 0067)
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Holy Name Medical Center ( Site 0037)
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Northwell Health- Monter Cancer Center ( Site 0075)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Sanford Roger Maris Cancer Center ( Site 0082)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Miami Valley Hospital [Dayton, OH] ( Site 0073)
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Bing Cancer Center ( Site 0044)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
OSU Wexner Medical Center ( Site 0076)
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Women and Infants Hospital [Providence, RI] ( Site 0039)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Sanford Gynecology Oncology ( Site 0004)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Texas Oncology, P.A. - Bedford ( Site 8005)
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Parkland Hospital ( Site 0081)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern Medical Center ( Site 0046)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Cancer Specialists, PC ( Site 8003)
City
Gainesville
State/Province
Virginia
ZIP/Postal Code
20155
Country
United States
Facility Name
MEDICAL COLLEGE OF WISCONSIN ( Site 0064)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St George Hospital ( Site 2207)
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Cairns and Hinterland Hospital and Health Service ( Site 2201)
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Ballarat Health Services ( Site 2202)
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Monash Health ( Site 2204)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Sunshine Hospital. ( Site 2205)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Imelda Ziekenhuis Bonheiden ( Site 0301)
City
Bonheiden
State/Province
Antwerpen
ZIP/Postal Code
1932
Country
Belgium
Facility Name
UZ Leuven Campus Gasthuisberg ( Site 0306)
City
Leuven
State/Province
Antwerpen
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc ( Site 0312)
City
Brussels
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Grand Hopital de Charleroi ( Site 0302)
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU de Liege ( Site 0310)
City
Liège
State/Province
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Jessa Ziekenhuis ( Site 0309)
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Centre Hospitalier de l'Ardenne ( Site 0303)
City
Libramont
State/Province
Luxembourg
ZIP/Postal Code
6800
Country
Belgium
Facility Name
AZ Maria Middelares Gent ( Site 0300)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent ( Site 0307)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Instituto do Cancer do Ceara ( Site 2707)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)
City
Goiania
State/Province
Goias
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital Erasto Gaertner ( Site 2716)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
82520-060
Country
Brazil
Facility Name
Hospital de Caridade de Ijui ( Site 2712)
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital Bruno Born ( Site 2704)
City
Lajeado
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95900-000
Country
Brazil
Facility Name
Hospital Nossa Senhora Da Conceicao ( Site 2703)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
City
Sao Paulo
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Tom Baker Cancer Centre ( Site 0200)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Kingston Health Sciences Centre ( Site 0207)
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
The Credit Valley Hospital ( Site 0206)
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Princess Margaret Hospital.. ( Site 0202)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Royal Victoria Hospital McGill University Health Centre ( Site 0211)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centro Investigación del Cáncer James Lind ( Site 2810)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4780000
Country
Chile
Facility Name
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810218
Country
Chile
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 2800)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500922
Country
Chile
Facility Name
Sociedad Oncovida S.A. ( Site 2807)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Iram Cancer Research ( Site 2809)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7630370
Country
Chile
Facility Name
Pontificia Universidad Catolica de Chile ( Site 2805)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330032
Country
Chile
Facility Name
Oncocentro ( Site 2801)
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Centro Oncologico Antofagasta ( Site 2804)
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Facility Name
Biomelab S A S ( Site 2900)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)
City
Valledupar
State/Province
Cesar
ZIP/Postal Code
200001
Country
Colombia
Facility Name
Oncomedica S.A. ( Site 2911)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia E.S.E ( Site 2910)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110321
Country
Colombia
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 2909)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Hemato Oncologos S.A. ( Site 2906)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Fakultni nemocnice Brno ( Site 0404)
City
Brno
State/Province
Brno-mesto
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava ( Site 0403)
City
Ostrava-Poruba
State/Province
Moravskoslezsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze ( Site 0400)
City
Praha
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Nemocnice Na Bulovce ( Site 0401)
City
Praha
State/Province
Praha, Hlavni Mesto
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc ( Site 0402)
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Hopital Prive Jean Mermoz ( Site 0607)
City
Lyon
State/Province
Auvergne
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Paul Strauss ( Site 0615)
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67065
Country
France
Facility Name
Hopital de la Timone ( Site 0617)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Brest -Site Hopital Morvan ( Site 0616)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Institut de Cancerologie Lucien Neuwirth ( Site 0613)
City
Saint-Priest-en-Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
Centre D Oncologie de Gentilly ( Site 0609)
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54100
Country
France
Facility Name
Institut Gustave Roussy ( Site 0600)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Hopital Tenon ( Site 0612)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)
City
Stuttgart
State/Province
Baden-Wurttemberg
ZIP/Postal Code
70199
Country
Germany
Facility Name
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
72074
Country
Germany
Facility Name
Uniklinik RWTH Aachen ( Site 0718)
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Gynaekologisches Zentrum ( Site 0712)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53111
Country
Germany
Facility Name
Klinikum Dortmund gGmbH ( Site 0717)
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf ( Site 0704)
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
HELIOS Klinikum Krefeld ( Site 0715)
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47805
Country
Germany
Facility Name
Universitaetsklinikum Muenster ( Site 0720)
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)
City
Saarbruecken
State/Province
Saarland
ZIP/Postal Code
66113
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH ( Site 0711)
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Facility Name
Staedtisches Krankenhaus Kiel GmbH ( Site 0709)
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24116
Country
Germany
Facility Name
Charite Campus Virchow-Klinikum - CVK ( Site 0700)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)
City
Miskolc
State/Province
Borsod-Abauj-Zemplen
ZIP/Postal Code
1051
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet ( Site 0800)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz ( Site 0803)
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 0801)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Soroka Medical Center ( Site 1006)
City
Beer-Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Hillel Yaffe Medical Center ( Site 1011)
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Facility Name
Carmel Medical Center ( Site 1007)
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Rambam Medical Center ( Site 1002)
City
Haifa
ZIP/Postal Code
3525408
Country
Israel
Facility Name
Edith Wolfson Medical Center ( Site 1003)
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Shaare Zedek Medical Center ( Site 1005)
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center ( Site 1004)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 1000)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1001)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)
City
Bari
State/Province
Abruzzo
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Europeo di Oncologia ( Site 1100)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS ( Site 1113)
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale Cannizzaro ( Site 1110)
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
ASST Lecco. Ospedale A. Manzoni ( Site 1101)
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
A.O.U. Federico II di Napoli ( Site 1107)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico Umberto I ( Site 1111)
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico Universitario Gemelli ( Site 1105)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Presidio Ospedaliero Santa Chiara ( Site 1109)
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
A.O. Univ. S. M. della Misericordia ( Site 1114)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
National Cancer Center Hospital East ( Site 2602)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center ( Site 2601)
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Ehime University Hospital ( Site 2600)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Gunma Prefectural Cancer Center ( Site 2609)
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
Hokkaido University Hospital ( Site 2607)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Iwate Medical University Hospital ( Site 2606)
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital ( Site 2613)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
University of the Ryukyus Hospital ( Site 2616)
City
Nakagami-gun
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 2604)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2614)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Defense Medical College Hospital ( Site 2608)
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-8513
Country
Japan
Facility Name
Kyorin University Hospital ( Site 2610)
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Kagoshima City Hospital ( Site 2612)
City
Kagoshima
ZIP/Postal Code
890-8760
Country
Japan
Facility Name
Niigata Cancer Center Hospital ( Site 2618)
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka International Cancer Institute ( Site 2617)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 2605)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Seoul National University Bundang Hospital ( Site 2404)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 2403)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2400)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2402)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2401)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Bialostockie Centrum Onkologii ( Site 1412)
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o. ( Site 1407)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-102
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)
City
Kielce
State/Province
Swietokrzyskie
ZIP/Postal Code
25-734
Country
Poland
Facility Name
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Arkhangelsk Clinical Oncological Dispensary ( Site 1508)
City
Arkhangelsk
State/Province
Arkhangel Skaya Oblast
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
City
Ufa
State/Province
Baskortostan, Respublika
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
A. Tsyb Medical Radiological Research Center ( Site 1513)
City
Obninsk
State/Province
Kaluzskaja Oblast
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FSCC of Special Types of Med. Care and Technologies ( Site 1503)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
Medical Rehabilitation Center ( Site 1502)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
City Clinical Oncology Center ( Site 1505)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)
City
Saint-Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Groote Schuur Hospital ( Site 1704)
City
Cape Town
State/Province
Gauteng
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Wits Clinical Research ( Site 1702)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Department of Medical Oncology ( Site 1703)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Curo Oncology ( Site 1710)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0031
Country
South Africa
Facility Name
Wilgers Oncology Centre ( Site 1705)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0081
Country
South Africa
Facility Name
Little Company of Mary Hospital ( Site 1700)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Sandton Oncology Medical Group PTY LTD ( Site 1712)
City
Sandton
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Facility Name
The Oncology Centre ( Site 1709)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Cancercare ( Site 1706)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Outeniqua Cancercare Oncology Unit ( Site 1708)
City
George
State/Province
Western Cape
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Cape Town Oncology Trials Pty Ltd ( Site 1707)
City
Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08909
Country
Spain
Facility Name
Xarxa Assistencial Universitaria Manresa ( Site 1605)
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital de Terrassa ( Site 1606)
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Facility Name
Hospital Universitario de Donostia ( Site 1602)
City
Donostia
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)
City
A Coruna
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Instituto Valenciano de Oncologia ( Site 1601)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario de Valencia ( Site 1610)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Provincial San Pedro de Alcantara ( Site 1607)
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti ( Site 1609)
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Clinica Universitaria de Navarra ( Site 1600)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 1604)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Changhua Christian Hospital ( Site 2507)
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 2506)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 2510)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 2508)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2502)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
MacKay Memorial Hospital ( Site 2500)
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 2503)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital ( Site 2501)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Istanbul Acibadem University Atakent Hospital ( Site 1902)
City
Kucukcekmece
State/Province
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Facility Name
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)
City
Ankara
ZIP/Postal Code
06050
Country
Turkey
Facility Name
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Akdeniz Universitesi Tıp Fakultesi ( Site 1901)
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Uludag Universitesi Tip Fakultesi ( Site 1904)
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Facility Name
Medipol Universite Hastanesi ( Site 1909)
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Facility Name
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)
City
Sakarya
ZIP/Postal Code
54290
Country
Turkey
Facility Name
MI Precarpathian Clinical Oncology Center ( Site 2181)
City
Ivano-Frankivsk
State/Province
Ivano-Frankivska Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli
City
Khmelnytskyi
State/Province
Khmelnytska Oblast
ZIP/Postal Code
29009
Country
Ukraine
Facility Name
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)
City
Lviv
State/Province
Lvivska Oblast
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 2121)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)
City
Sumy
State/Province
Sumska Oblast
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Central City Clinical Hospital ( Site 2150)
City
Uzhgorod
State/Province
Zakarpatska Oblast
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center ( Site 2140)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=7339-001&&kw=7339-001
Description
Plain Language Summary

Learn more about this trial

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)

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