Ovarian CancerPhase 3NCT03740165
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)
A Phase 3 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Ovarian Cancer and Fallopian Tube Cancer, run by Merck Sharp & Dohme LLC at 227 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- What is being tested?
- Pembrolizumab, Carboplatin and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,367 participants
- Where
- 227 sitesin 22 countries
- Study dates
- 18 Dec 2018to 14 Apr 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
227 sites in 22 countries.
227 sites in 22 countries
United States43 sites
Emory School of Medicine ( Site 0053)
Atlanta, Georgia, 30322
Weinberg Cancer Institute at Franklin Square ( Site 0035)
Baltimore, Maryland, 21237
Texas Oncology, P.A. - Bedford ( Site 8005)
Bedford, Texas, 76022
University of Alabama at Birmingham (UAB) ( Site 0036)
Birmingham, Alabama, 35233
Disney Family Cancer Center ( Site 0042)
Burbank, California, 91505
MD Anderson Cancer Center at Cooper ( Site 0067)
Camden, New Jersey, 08103
Miami Valley Hospital [Dayton, OH] ( Site 0073)
Centerville, Ohio, 45459
Rush University Medical Center ( Site 0019)
Chicago, Illinois, 60612
University of Chicago ( Site 0049)
Chicago, Illinois, 60637
Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)
Cincinnati, Ohio, 45242
The Bing Cancer Center ( Site 0044)
Columbus, Ohio, 43214
Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)
Dallas, Texas, 75231
Parkland Hospital ( Site 0081)
Dallas, Texas, 75235
UT Southwestern Medical Center ( Site 0046)
Dallas, Texas, 75390
Sanford Roger Maris Cancer Center ( Site 0082)
Fargo, North Dakota, 58122
Northeast Georgia Medical Center ( Site 0029)
Gainesville, Georgia, 30501
Virginia Cancer Specialists, PC ( Site 8003)
Gainesville, Virginia, 20155
OSU Wexner Medical Center ( Site 0076)
Hilliard, Ohio, 43026
Dr. Sudarshan K. Sharma, LTD ( Site 0061)
Hinsdale, Illinois, 60521
Saint Vincent Hospital and Health Center ( Site 0012)
Indianapolis, Indiana, 46260
University of Iowa Hospital and Clinics ( Site 0005)
Iowa City, Iowa, 52242
Saint Dominic - Jackson Memorial Hospital ( Site 0072)
Jackson, Mississippi, 39216
Northwell Health- Monter Cancer Center ( Site 0075)
Lake Success, New York, 11042
Dartmouth Hitchcock Medical Center ( Site 0024)
Lebanon, New Hampshire, 03756
University of Kentucky ( Site 0045)
Lexington, Kentucky, 40536
MEDICAL COLLEGE OF WISCONSIN ( Site 0064)
Milwaukee, Wisconsin, 53226
Smilow Cancer Center at Yale-New Haven ( Site 0057)
New Haven, Connecticut, 06511
Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)
Oakland, California, 94611
Nebraska Methodist Hospital ( Site 0063)
Omaha, Nebraska, 68114
Women and Infants Hospital [Providence, RI] ( Site 0039)
Providence, Rhode Island, 02905
Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)
Roseville, California, 95661
Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)
Sacramento, California, 95814
Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)
San Francisco, California, 94115
Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)
Santa Clara, California, 95051
Sarasota Memorial Hospital ( Site 0023)
Sarasota, Florida, 34239
Memorial Health University Medical Center ( Site 0011)
Savannah, Georgia, 31404
Sanford Gynecology Oncology ( Site 0004)
Sioux Falls, South Dakota, 57104
Washington University - School of Medicine ( Site 0062)
St Louis, Missouri, 63110
Holy Name Medical Center ( Site 0037)
Teaneck, New Jersey, 07666
University of Arizona Cancer Center ( Site 0074)
Tucson, Arizona, 85719
Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)
Tyler, Texas, 75702
Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)
Vallejo, California, 94589
Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)
Walnut Creek, California, 94596
Japan16 sites
Saitama Medical University International Medical Center ( Site 2604)
Hidaka, Saitama, 350-1298
Kagoshima City Hospital ( Site 2612)
Kagoshima, 890-8760
National Cancer Center Hospital East ( Site 2602)
Kashiwa, Chiba, 277-8577
St. Marianna University School of Medicine Hospital ( Site 2613)
Kawasaki, Kanagawa, 216-8511
Saitama Cancer Center ( Site 2614)
Kitaadachi-gun, Saitama, 362-0806
National Hospital Organization Shikoku Cancer Center ( Site 2601)
Matsuyama, Ehime, 791-0280
Kyorin University Hospital ( Site 2610)
Mitaka, Tokyo, 181-8611
University of the Ryukyus Hospital ( Site 2616)
Nakagami-gun, Okinawa, 903-0215
Niigata Cancer Center Hospital ( Site 2618)
Niigata, 951-8566
Osaka International Cancer Institute ( Site 2617)
Osaka, 541-8567
Gunma Prefectural Cancer Center ( Site 2609)
Ōta, Gunma, 373-8550
Hokkaido University Hospital ( Site 2607)
Sapporo, Hokkaido, 060-8648
Iwate Medical University Hospital ( Site 2606)
Shiwa-gun, Iwate, 028-3695
National Defense Medical College Hospital ( Site 2608)
Tokorozawa, Saitama, 359-8513
National Cancer Center Hospital ( Site 2605)
Tokyo, 104-0045
Ehime University Hospital ( Site 2600)
Tōon, Ehime, 791-0295
Italy13 sites
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)
Bari, Abruzzo, 70124
Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)
Benevento, 82100
Ospedale Cannizzaro ( Site 1110)
Catania, 95126
ASST Lecco. Ospedale A. Manzoni ( Site 1101)
Lecco, 23900
Istituto Europeo di Oncologia ( Site 1100)
Milan, Lombardy, 20141
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)
Milan, 20133
A.O.U. Federico II di Napoli ( Site 1107)
Naples, 80131
Istituto Oncologico Veneto IRCCS ( Site 1113)
Padova, Veneto, 35128
Azienda Ospedaliera Policlinico Umberto I ( Site 1111)
Roma, 00161
Policlinico Universitario Gemelli ( Site 1105)
Roma, 00168
Presidio Ospedaliero Santa Chiara ( Site 1109)
Trento, 38122
A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)
Turin, Piedmont, 10126
A.O. Univ. S. M. della Misericordia ( Site 1114)
Udine, 33100
Germany12 sites
Uniklinik RWTH Aachen ( Site 0718)
Aachen, North Rhine-Westphalia, 52074
Charite Campus Virchow-Klinikum - CVK ( Site 0700)
Berlin, 13353
Gynaekologisches Zentrum ( Site 0712)
Bonn, North Rhine-Westphalia, 53111
Klinikum Chemnitz gGmbH ( Site 0711)
Chemnitz, Saxony, 09116
Klinikum Dortmund gGmbH ( Site 0717)
Dortmund, North Rhine-Westphalia, 44137
Universitaetsklinikum Duesseldorf ( Site 0704)
Düsseldorf, North Rhine-Westphalia, 40225
Staedtisches Krankenhaus Kiel GmbH ( Site 0709)
Kiel, Schleswig-Holstein, 24116
HELIOS Klinikum Krefeld ( Site 0715)
Krefeld, North Rhine-Westphalia, 47805
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)
Munich, Bavaria, 72074
Universitaetsklinikum Muenster ( Site 0720)
Münster, North Rhine-Westphalia, 48149
Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)
Saarbrücken, Saarland, 66113
Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)
Stuttgart, Baden-Wurttemberg, 70199
South Africa12 sites
Groote Schuur Hospital ( Site 1704)
Cape Town, Gauteng, 7925
Cancercare ( Site 1706)
Cape Town, Western Cape, 7700
The Oncology Centre ( Site 1709)
Durban, KwaZulu-Natal, 4091
Outeniqua Cancercare Oncology Unit ( Site 1708)
George, Western Cape, 6530
Wits Clinical Research ( Site 1702)
Johannesburg, Gauteng, 2193
Cape Town Oncology Trials Pty Ltd ( Site 1707)
Kraaifontein, Western Cape, 7570
Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)
Port Elizabeth, Eastern Cape, 6045
Department of Medical Oncology ( Site 1703)
Pretoria, Gauteng, 0002
Curo Oncology ( Site 1710)
Pretoria, Gauteng, 0031
Wilgers Oncology Centre ( Site 1705)
Pretoria, Gauteng, 0081
Little Company of Mary Hospital ( Site 1700)
Pretoria, Gauteng, 0181
Sandton Oncology Medical Group PTY LTD ( Site 1712)
Sandton, Gauteng, 2196
Spain11 sites
Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)
A Coruña, La Coruna, 15006
Hospital Provincial San Pedro de Alcantara ( Site 1607)
Cáceres, 10003
Hospital Universitario de Donostia ( Site 1602)
Donostia / San Sebastian, Gipuzkoa, 20014
Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)
L'Hospitalet de Llobregat, Barcelona, 08909
Hospital Universitario Lucus Augusti ( Site 1609)
Lugo, 27003
Clinica Universitaria de Navarra ( Site 1600)
Madrid, 28027
Xarxa Assistencial Universitaria Manresa ( Site 1605)
Manresa, Barcelona, 08243
Hospital Universitario Virgen del Rocio ( Site 1604)
Seville, 41013
Hospital de Terrassa ( Site 1606)
Terrassa, Barcelona, 08227
Instituto Valenciano de Oncologia ( Site 1601)
Valencia, Valenciana, Comunitat, 46009
Hospital General Universitario de Valencia ( Site 1610)
Valencia, Valenciana, Comunitat, 46014
Brazil10 sites
Hospital Erasto Gaertner ( Site 2716)
Curitiba, Paraná, 82520-060
Instituto do Cancer do Ceara ( Site 2707)
Fortaleza, Ceará, 60430-230
Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)
Goiânia, Goiás, 74605-070
Hospital de Caridade de Ijui ( Site 2712)
Ijuí, Rio Grande do Sul, 98700-000
Hospital Bruno Born ( Site 2704)
Lajeado, Rio Grande do Sul, 95900-000
Hospital Nossa Senhora Da Conceicao ( Site 2703)
Porto Alegre, Rio Grande do Sul, 91350-200
Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)
Rio de Janeiro, 20220-410
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)
São Paulo, 01246-000
Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)
São Paulo, 01317-000
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)
São Paulo, 01321-001
Belgium9 sites
Imelda Ziekenhuis Bonheiden ( Site 0301)
Bonheiden, Antwerpen, 1932
Cliniques Universitaires Saint-Luc ( Site 0312)
Brussels, Bruxelles-Capitale, Region de, 1200
Grand Hopital de Charleroi ( Site 0302)
Charleroi, Hainaut, 6000
AZ Maria Middelares Gent ( Site 0300)
Ghent, Oost-Vlaanderen, 9000
UZ Gent ( Site 0307)
Ghent, Oost-Vlaanderen, 9000
Jessa Ziekenhuis ( Site 0309)
Hasselt, Limburg, 3500
UZ Leuven Campus Gasthuisberg ( Site 0306)
Leuven, Antwerpen, 3000
Centre Hospitalier de l'Ardenne ( Site 0303)
Libramont, Luxembourg, 6800
CHU de Liege ( Site 0310)
Liège, Liege, 4000
France9 sites
CHU de Brest -Site Hopital Morvan ( Site 0616)
Brest, Brittany Region, 29200
Hopital Prive Jean Mermoz ( Site 0607)
Lyon, Auvergne, 69008
Hopital de la Timone ( Site 0617)
Marseille, Bouches-du-Rhone, 13005
Centre D Oncologie de Gentilly ( Site 0609)
Nancy, Meurthe-et-Moselle, 54100
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)
Nîmes, Gard, 30029
Hopital Tenon ( Site 0612)
Paris, 75020
Institut de Cancerologie Lucien Neuwirth ( Site 0613)
Saint-Priest-en-Jarez, Pays de la Loire Region, 42270
Centre Paul Strauss ( Site 0615)
Strasbourg, Bas-Rhin, 67065
Institut Gustave Roussy ( Site 0600)
Villejuif, Val-de-Marne, 94800
Israel9 sites
Soroka Medical Center ( Site 1006)
Beersheba, 8410101
Hillel Yaffe Medical Center ( Site 1011)
Hadera, 3810101
Carmel Medical Center ( Site 1007)
Haifa, 3436212
Rambam Medical Center ( Site 1002)
Haifa, 3525408
Edith Wolfson Medical Center ( Site 1003)
Holon, 5822012
Shaare Zedek Medical Center ( Site 1005)
Jerusalem, 9103102
Rabin Medical Center ( Site 1004)
Petah Tikva, 4941492
Chaim Sheba Medical Center ( Site 1000)
Ramat Gan, 5262000
Sourasky Medical Center ( Site 1001)
Tel Aviv, 6423906
Russia9 sites
Arkhangelsk Clinical Oncological Dispensary ( Site 1508)
Arkhangelsk, Arkhangelskaya oblast, 163045
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)
Kazan', Tatarstan, Respublika, 420029
FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)
Moscow, Moscow, 115478
FSCC of Special Types of Med. Care and Technologies ( Site 1503)
Moscow, Moscow, 115682
Medical Rehabilitation Center ( Site 1502)
Moscow, Moscow, 125367
A. Tsyb Medical Radiological Research Center ( Site 1513)
Obninsk, Kaluzskaja Oblast, 249036
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)
Saint Petersburg, Sankt-Peterburg, 197758
City Clinical Oncology Center ( Site 1505)
Saint Petersburg, Sankt-Peterburg, 198255
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
Ufa, Baskortostan, Respublika, 450054
Turkey (Türkiye)9 sites
Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)
Ankara, 06050
Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)
Ankara, 06590
Akdeniz Universitesi Tıp Fakultesi ( Site 1901)
Antalya, 07070
Uludag Universitesi Tip Fakultesi ( Site 1904)
Bursa, 16059
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)
Istanbul, 34093
Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)
Istanbul, 34147
Medipol Universite Hastanesi ( Site 1909)
Istanbul, 34214
Istanbul Acibadem University Atakent Hospital ( Site 1902)
Küçükçekmece, Istanbul, 34303
Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)
Sakarya, 54290
Canada8 sites
Tom Baker Cancer Centre ( Site 0200)
Calgary, Alberta, T2N 4N2
CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)
Chicoutimi, Quebec, G7H 5H6
Kingston Health Sciences Centre ( Site 0207)
Kingston, Ontario, K7L 2V7
The Credit Valley Hospital ( Site 0206)
Mississauga, Ontario, L5M 2N1
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)
Montreal, Quebec, H2X 0A9
Royal Victoria Hospital McGill University Health Centre ( Site 0211)
Montreal, Quebec, H4A 3J1
Princess Margaret Hospital.. ( Site 0202)
Toronto, Ontario, M5G 2M9
Chile8 sites
Centro Oncologico Antofagasta ( Site 2804)
Antofagasta, 1240000
Fundacion Arturo Lopez Perez FALP ( Site 2800)
Santiago, Region M. de Santiago, 7500922
Sociedad Oncovida S.A. ( Site 2807)
Santiago, Region M. de Santiago, 7510032
Iram Cancer Research ( Site 2809)
Santiago, Region M. de Santiago, 7630370
Pontificia Universidad Catolica de Chile ( Site 2805)
Santiago, Region M. de Santiago, 8330032
Centro Investigación del Cáncer James Lind ( Site 2810)
Temuco, Araucania, 4780000
Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)
Temuco, Araucania, 4810218
Oncocentro ( Site 2801)
Viña del Mar, Valparaiso, 2520598
Taiwan8 sites
Changhua Christian Hospital ( Site 2507)
Changhua, 50006
China Medical University Hospital ( Site 2506)
Taichung, 40447
Taichung Veterans General Hospital ( Site 2510)
Taichung, 40705
National Cheng Kung University Hospital ( Site 2508)
Tainan, 704
National Taiwan University Hospital ( Site 2502)
Taipei, 10002
MacKay Memorial Hospital ( Site 2500)
Taipei, 10449
Taipei Veterans General Hospital ( Site 2503)
Taipei, 11217
Linkou Chang Gung Memorial Hospital ( Site 2501)
Taoyuan, 333
Ukraine8 sites
MI Precarpathian Clinical Oncology Center ( Site 2181)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)
Kharkiv, Kharkiv Oblast, 61024
Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli
Khmelnytskyi, Khmelnytskyi Oblast, 29009
Kyiv City Clinical Oncological Center ( Site 2140)
Kyiv, 03115
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)
Lviv, Lviv Oblast, 79031
MI Odessa Regional Oncological Centre ( Site 2121)
Odesa, Odesa Oblast, 65055
RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)
Sumy, Sumska Oblast, 40022
Central City Clinical Hospital ( Site 2150)
Uzhhorod, Zakarpattia Oblast, 88000
Colombia7 sites
Biomelab S A S ( Site 2900)
Barranquilla, Atlántico, 080002
Instituto Nacional de Cancerologia E.S.E ( Site 2910)
Bogotá, Bogota D.C., 110321
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)
Bogotá, Bogota D.C., 111321
Centro Medico Imbanaco de Cali S.A ( Site 2909)
Cali, Valle del Cauca Department, 760042
Hemato Oncologos S.A. ( Site 2906)
Cali, Valle del Cauca Department, 760042
Oncomedica S.A. ( Site 2911)
Montería, Departamento de Córdoba, 230002
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)
Valledupar, Cesar Department, 200001
Poland6 sites
Bialostockie Centrum Onkologii ( Site 1412)
Bialystok, Podlaskie Voivodeship, 15-027
Szpitale Pomorskie Sp. z o.o. ( Site 1407)
Gdynia, Pomeranian Voivodeship, 81-519
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)
Gliwice, Silesian Voivodeship, 44-102
Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)
Kielce, Świętokrzyskie Voivodeship, 25-734
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna
Poznan, Greater Poland Voivodeship, 61-848
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warsaw, Masovian Voivodeship, 02-781
Australia5 sites
Ballarat Health Services ( Site 2202)
Ballarat, Victoria, 3350
Cairns and Hinterland Hospital and Health Service ( Site 2201)
Cairns, Queensland, 4870
Monash Health ( Site 2204)
Clayton, Victoria, 3168
St George Hospital ( Site 2207)
Kogarah, New South Wales, 2217
Sunshine Hospital. ( Site 2205)
St Albans, Victoria, 3021
Czechia5 sites
Fakultni nemocnice Brno ( Site 0404)
Brno, Brno-mesto, 602 00
Fakultni nemocnice Olomouc ( Site 0402)
Olomouc, 779 00
Fakultni nemocnice Ostrava ( Site 0403)
Ostrava-Poruba, Moravian-Silesian Region, 708 52
Vseobecna fakultni nemocnice v Praze ( Site 0400)
Prague, Praha, Hlavni Mesto, 120 00
Nemocnice Na Bulovce ( Site 0401)
Prague, Praha, Hlavni Mesto, 180 81
Hungary5 sites
Orszagos Onkologiai Intezet ( Site 0800)
Budapest, 1122
Uzsoki Utcai Korhaz ( Site 0803)
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont ( Site 0801)
Debrecen, 4032
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)
Miskolc, Borsod-Abauj Zemplen county, 1051
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)
Pécs, Baranya, 7624
South Korea5 sites
Seoul National University Bundang Hospital ( Site 2404)
Seongnam-si, Kyonggi-do, 13620
Seoul National University Hospital ( Site 2403)
Seoul, 03080
Severance Hospital Yonsei University Health System ( Site 2400)
Seoul, 03722
Asan Medical Center ( Site 2402)
Seoul, 05505
Samsung Medical Center ( Site 2401)
Seoul, 06351
About this study
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)
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.
Read the 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, and will receive carboplatin/paclitaxel* for 5 cycles plus:
- 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.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Being tested
- Pembrolizumab, Placebo for pembrolizumab, Carboplatin, Paclitaxel, Olaparib
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
IV infusion
Placebo for pembrolizumabDrug
Also called normal saline or dextrose
IV infusion
CarboplatinDrug
Also called PARAPLATIN®
IV infusion
PaclitaxelDrug
Also called TAXOL®
IV infusion
OlaparibDrug
Also called MK-7339, LYNPARZA®
Oral tablet
Placebo for olaparibDrug
Oral tablet
BevacizumabBiological
Also called AVASTIN®
IV infusion
DocetaxelDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin + Paclitaxel + Pembrolizumab + Olaparib | Experimental | 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. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Olaparib; Biological: Bevacizumab; Drug: Docetaxel |
| Carboplatin + Paclitaxel + Pembrolizumab | Experimental | 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. Receives: Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo for olaparib; Biological: Bevacizumab; Drug: Docetaxel |
| Carboplatin + Paclitaxel | Active comparator | 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. Receives: Drug: Placebo for pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Placebo for olaparib; Biological: Bevacizumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 new 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 tumors (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
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 new 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. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Secondary outcomes (20)
Overall Survival (OS) in Participants With PD-L1 Positive Tumors (CPS ≥ 10)
OS is defined as the time from the date of randomization to death due to any cause. The OS is reported for all participants with PD-L1 positive tumors (CPS≥10). The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
OS in All Participants
OS is defined as the time from the date of randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
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 new 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 (CPS≥10). PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 66 months
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 new 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 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 66 months
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 after second-line treatment 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 new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for participants with PD-L1 positive tumors (CPS≥10). PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
PFS2 Following Discontinuation of Study Treatment as Assessed by the Investigator in All Participants
PFS2 is defined as the time from randomization until PD after second-line treatment 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 new lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS2 per RECIST 1.1 as assessed by the Investigator is reported for all participants. PFS2 was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) (GHS/QoL) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. Change from baseline to Week 45 in EORTC QLQ-C30 Items 29 and 30 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).
Measured: Baseline and week 45
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
Participant responses to 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 (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. Change from baseline to Week 45 in EORTC QLQ-OV28 Items 31-36 combined scores was calculated based on a constrained longitudinal data analysis (cLDA) model with scores as response variable; covariates for treatment by time interaction and stratification factors (debulking surgery [planned interval vs R0 following primary vs R1 following primary], and bevacizumab use [Yes vs No], and PD-L1 CPS [<10 vs ≥10]).
Measured: Baseline and week 45
Time to Deterioration (TTD) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
The EORTC-QLQ-C30 is a 30-item questionnaire to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1=Very Poor; 7=Excellent). Using linear transformation, raw scores were standardized so scores ranged from 0 to 100; higher score = better outcome. TTD is defined as the time from the first EORTC QLQ-C30 Items 29 and 30 combined scores to deterioration (defined as ≥10-point decrease in GHS/QoL score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 31 months
Time to Deterioration (TTD) of Abdominal/GI Symptoms Using EORTC QLQ-OV28
Participant responses to 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 (questions 31-36) were scored on a 4-point scale (1=Not at all; 4=Very much); lower score = better abdominal/GI symptoms. Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100; a lower score indicating a better overall outcome. TTD is defined as the time from the first EORTC QLQ-OV28 questions 31-36 combined scores to deterioration (defined as ≥10-point decrease in abdominal/GI symptoms score from baseline with confirmation under right-censoring rule [the last observation]) or death, whichever occurs first. TTD was calculated using the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 31 months
Time to First Subsequent Anti-cancer Treatment (TFST) in Participants With PD-L1 Positive Tumors (CPS≥10)
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Time to First Subsequent Anti-cancer Treatment (TFST) in All Participants
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Time to Second Subsequent Anti-cancer Treatment (TSST) in Participants With PD-L1 Positive Tumors (CPS≥10)
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Time to Second Subsequent Anti-cancer Treatment (TSST) in All Participants
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Time to Discontinuation of Study Treatment or Death (TDT) in Participants With PD-L1 Positive Tumors (CPS≥10)
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Time to Discontinuation of Study Treatment or Death (TDT) in All Participants
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 was determined from the product-limit (Kaplan-Meier) method for censored data.
Measured: Up to approximately 67 months
Pathological Complete Response (pCR) Rate in Participants With PD-L1 Positive Tumors (CPS≥10)
pCR is defined as the disappearance of all known disease noted prior to surgery; all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The percentage of participants who experience pCR was determined based on Miettinen \& Nurminen method stratified by Bevacizumab use (yes versus no).
Measured: Up to approximately 21 months
Pathological Complete Response (pCR) Rate in All Participants
pCR is defined as the disappearance of all known disease noted prior to surgery; all surgical specimens collected during the interval debulking surgery are microscopically negative for malignancy. The percentage of participants who experience pCR was determined based on Miettinen \& Nurminen method stratified by Bevacizumab use (yes versus no) and PD-L1 status (CPS <10 versus CPS>=10).
Measured: Up to approximately 26 months
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 intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 73 months (anticipated)
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 intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 6 years (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start18 Dec 2018
- Primary completion26 Aug 2024
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740165
- Sponsor's protocol ID
- 7339-001
- Other IDs
- ENGOT-ov43, MK-7339-001, KEYLYNK-001, 194619, GOG-3036, 2022-502124-52-00, U1111-1283-3793, 2018-001973-25
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2018
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Vergote I, Cibula D, Powell M, Laenen A, Nieuwenhuysen EV, Topuz S, Gonzalez-Martin A, Fujiwara K, Safina S, Bagameri A, Oliver M, Lee JY, Salutari V, Korach J, Lu CH, Madry R, Vulsteke C, Colombo N, Sehouli J, Klat J, Ruiz EY, Gilbert L, Pautier P, Pardo B, Kridelka F, Wei J, Toker S, Yamada K, Coleman RL; ENGOT-OV43/GOG-3036/KEYLYNK-001 investigators. Chemotherapy with or without pembrolizumab followed by maintenance pembrolizumab with or without olaparib as first-line treatment of patients with advanced BRCA non-mutated epithelial ovarian cancer (ENGOT-OV43/GOG-3036/KEYLYNK-001): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Sep 7:S1470-2045(26)00223-8. doi: 10.1016/S1470-2045(26)00223-8. Online ahead of print.
PubMed 42705254