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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03740165
Other study ID # 7339-001
Secondary ID ENGOT-ov43MK-733
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 18, 2018
Est. completion date May 29, 2026

Study information

Verified date December 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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: 1. 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 2. 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 3. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1367
Est. completion date May 29, 2026
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Biological:
Pembrolizumab
IV infusion
Drug:
Placebo for pembrolizumab
IV infusion
Carboplatin
IV infusion
Paclitaxel
IV infusion
Olaparib
Oral tablet
Placebo for olaparib
Oral tablet
Biological:
Bevacizumab
IV infusion
Drug:
Docetaxel
IV infusion

Locations

Country Name City State
Australia Ballarat Health Services ( Site 2202) Ballarat Victoria
Australia Cairns and Hinterland Hospital and Health Service ( Site 2201) Cairns Queensland
Australia Monash Health ( Site 2204) Clayton Victoria
Australia St George Hospital ( Site 2207) Kogarah New South Wales
Australia Sunshine Hospital. ( Site 2205) St Albans Victoria
Belgium Imelda Ziekenhuis Bonheiden ( Site 0301) Bonheiden Antwerpen
Belgium Cliniques Universitaires Saint-Luc ( Site 0312) Brussels Bruxelles-Capitale, Region De
Belgium Grand Hopital de Charleroi ( Site 0302) Charleroi Hainaut
Belgium AZ Maria Middelares Gent ( Site 0300) Gent Oost-Vlaanderen
Belgium UZ Gent ( Site 0307) Gent Oost-Vlaanderen
Belgium Jessa Ziekenhuis ( Site 0309) Hasselt Limburg
Belgium UZ Leuven Campus Gasthuisberg ( Site 0306) Leuven Antwerpen
Belgium Centre Hospitalier de l'Ardenne ( Site 0303) Libramont Luxembourg
Belgium CHU de Liege ( Site 0310) Liège Liege
Brazil Hospital Erasto Gaertner ( Site 2716) Curitiba Parana
Brazil Instituto do Cancer do Ceara ( Site 2707) Fortaleza Ceara
Brazil Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708) Goiania Goias
Brazil Hospital de Caridade de Ijui ( Site 2712) Ijui Rio Grande Do Sul
Brazil Hospital Bruno Born ( Site 2704) Lajeado Rio Grande Do Sul
Brazil Hospital Nossa Senhora Da Conceicao ( Site 2703) Porto Alegre Rio Grande Do Sul
Brazil Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700) Rio de Janeiro
Brazil Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706) Sao Paulo
Brazil Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714) Sao Paulo
Brazil Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710) Sao Paulo
Canada Tom Baker Cancer Centre ( Site 0200) Calgary Alberta
Canada CIUSSS du Saguenay-Lac-St-Jean ( Site 0218) Chicoutimi Quebec
Canada Kingston Health Sciences Centre ( Site 0207) Kingston Ontario
Canada The Credit Valley Hospital ( Site 0206) Mississauga Ontario
Canada Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208) Montreal Quebec
Canada CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219) Montreal Quebec
Canada Royal Victoria Hospital McGill University Health Centre ( Site 0211) Montreal Quebec
Canada Princess Margaret Hospital.. ( Site 0202) Toronto Ontario
Chile Centro Oncologico Antofagasta ( Site 2804) Antofagasta
Chile Fundacion Arturo Lopez Perez FALP ( Site 2800) Santiago Region M. De Santiago
Chile Iram Cancer Research ( Site 2809) Santiago Region M. De Santiago
Chile Pontificia Universidad Catolica de Chile ( Site 2805) Santiago Region M. De Santiago
Chile Sociedad Oncovida S.A. ( Site 2807) Santiago Region M. De Santiago
Chile Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808) Temuco Araucania
Chile Centro Investigación del Cáncer James Lind ( Site 2810) Temuco Araucania
Chile Oncocentro ( Site 2801) Vina del Mar Valparaiso
Colombia Biomelab S A S ( Site 2900) Barranquilla Atlantico
Colombia Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912) Bogota Distrito Capital De Bogota
Colombia Instituto Nacional de Cancerologia E.S.E ( Site 2910) Bogota Distrito Capital De Bogota
Colombia Centro Medico Imbanaco de Cali S.A ( Site 2909) Cali Valle Del Cauca
Colombia Hemato Oncologos S.A. ( Site 2906) Cali Valle Del Cauca
Colombia Oncomedica S.A. ( Site 2911) Monteria Cordoba
Colombia Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913) Valledupar Cesar
Czechia Fakultni nemocnice Brno ( Site 0404) Brno Brno-mesto
Czechia Fakultni nemocnice Olomouc ( Site 0402) Olomouc
Czechia Fakultni nemocnice Ostrava ( Site 0403) Ostrava-Poruba Moravskoslezsky Kraj
Czechia Nemocnice Na Bulovce ( Site 0401) Praha Praha, Hlavni Mesto
Czechia Vseobecna fakultni nemocnice v Praze ( Site 0400) Praha Praha, Hlavni Mesto
France CHU de Brest -Site Hopital Morvan ( Site 0616) Brest Bretagne
France Hopital Prive Jean Mermoz ( Site 0607) Lyon Auvergne
France Hopital de la Timone ( Site 0617) Marseille Bouches-du-Rhone
France Centre D Oncologie de Gentilly ( Site 0609) Nancy Meurthe-et-Moselle
France Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610) Nimes Gard
France Hopital Tenon ( Site 0612) Paris
France Institut de Cancerologie Lucien Neuwirth ( Site 0613) Saint-Priest-en-Jarez Loire
France Centre Paul Strauss ( Site 0615) Strasbourg Bas-Rhin
France Institut Gustave Roussy ( Site 0600) Villejuif Val-de-Marne
Germany Uniklinik RWTH Aachen ( Site 0718) Aachen Nordrhein-Westfalen
Germany Charite Campus Virchow-Klinikum - CVK ( Site 0700) Berlin
Germany Gynaekologisches Zentrum ( Site 0712) Bonn Nordrhein-Westfalen
Germany Klinikum Chemnitz gGmbH ( Site 0711) Chemnitz Sachsen
Germany Klinikum Dortmund gGmbH ( Site 0717) Dortmund Nordrhein-Westfalen
Germany Universitaetsklinikum Duesseldorf ( Site 0704) Duesseldorf Nordrhein-Westfalen
Germany Staedtisches Krankenhaus Kiel GmbH ( Site 0709) Kiel Schleswig-Holstein
Germany HELIOS Klinikum Krefeld ( Site 0715) Krefeld Nordrhein-Westfalen
Germany Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710) Muenchen Bayern
Germany Universitaetsklinikum Muenster ( Site 0720) Muenster Nordrhein-Westfalen
Germany Caritas Klinikum Saarbruecken St. Theresia ( Site 0702) Saarbruecken Saarland
Germany Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707) Stuttgart Baden-Wurttemberg
Hungary Orszagos Onkologiai Intezet ( Site 0800) Budapest
Hungary Uzsoki Utcai Korhaz ( Site 0803) Budapest
Hungary Debreceni Egyetem Klinikai Kozpont ( Site 0801) Debrecen
Hungary Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802) Miskolc Borsod-Abauj-Zemplen
Hungary Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805) Pecs Baranya
Israel Soroka Medical Center ( Site 1006) Beer-Sheva
Israel Hillel Yaffe Medical Center ( Site 1011) Hadera
Israel Carmel Medical Center ( Site 1007) Haifa
Israel Rambam Medical Center ( Site 1002) Haifa
Israel Edith Wolfson Medical Center ( Site 1003) Holon
Israel Shaare Zedek Medical Center ( Site 1005) Jerusalem
Israel Rabin Medical Center ( Site 1004) Petah Tikva
Israel Chaim Sheba Medical Center ( Site 1000) Ramat Gan
Israel Sourasky Medical Center ( Site 1001) Tel Aviv
Italy IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108) Bari Abruzzo
Italy Sacro Cuore di Gesu Fatebenefratelli ( Site 1112) Benevento
Italy Ospedale Cannizzaro ( Site 1110) Catania
Italy ASST Lecco. Ospedale A. Manzoni ( Site 1101) Lecco
Italy Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115) Milano
Italy Istituto Europeo di Oncologia ( Site 1100) Milano Lombardia
Italy A.O.U. Federico II di Napoli ( Site 1107) Napoli
Italy Istituto Oncologico Veneto IRCCS ( Site 1113) Padova Veneto
Italy Azienda Ospedaliera Policlinico Umberto I ( Site 1111) Roma
Italy Policlinico Universitario Gemelli ( Site 1105) Roma
Italy A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104) Torino Piemonte
Italy Presidio Ospedaliero Santa Chiara ( Site 1109) Trento
Italy A.O. Univ. S. M. della Misericordia ( Site 1114) Udine
Japan Saitama Medical University International Medical Center ( Site 2604) Hidaka Saitama
Japan Kagoshima City Hospital ( Site 2612) Kagoshima
Japan National Cancer Center Hospital East ( Site 2602) Kashiwa Chiba
Japan St. Marianna University School of Medicine Hospital ( Site 2613) Kawasaki Kanagawa
Japan Saitama Cancer Center ( Site 2614) Kitaadachi-gun Saitama
Japan National Hospital Organization Shikoku Cancer Center ( Site 2601) Matsuyama Ehime
Japan Kyorin University Hospital ( Site 2610) Mitaka Tokyo
Japan University of the Ryukyus Hospital ( Site 2616) Nakagami-gun Okinawa
Japan Niigata Cancer Center Hospital ( Site 2618) Niigata
Japan Osaka International Cancer Institute ( Site 2617) Osaka
Japan Gunma Prefectural Cancer Center ( Site 2609) Ota Gunma
Japan Hokkaido University Hospital ( Site 2607) Sapporo Hokkaido
Japan Iwate Medical University Hospital ( Site 2606) Shiwa-gun Iwate
Japan National Defense Medical College Hospital ( Site 2608) Tokorozawa Saitama
Japan National Cancer Center Hospital ( Site 2605) Tokyo
Japan Ehime University Hospital ( Site 2600) Toon Ehime
Korea, Republic of Seoul National University Bundang Hospital ( Site 2404) Seongnam-si Kyonggi-do
Korea, Republic of Asan Medical Center ( Site 2402) Seoul
Korea, Republic of Samsung Medical Center ( Site 2401) Seoul
Korea, Republic of Seoul National University Hospital ( Site 2403) Seoul
Korea, Republic of Severance Hospital Yonsei University Health System ( Site 2400) Seoul
Poland Bialostockie Centrum Onkologii ( Site 1412) Bialystok Podlaskie
Poland Szpitale Pomorskie Sp. z o.o. ( Site 1407) Gdynia Pomorskie
Poland Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406) Gliwice Slaskie
Poland Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410) Kielce Swietokrzyskie
Poland Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna Poznan Wielkopolskie
Poland Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Warszawa Mazowieckie
Russian Federation Arkhangelsk Clinical Oncological Dispensary ( Site 1508) Arkhangelsk Arkhangel Skaya Oblast
Russian Federation Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509) Kazan Tatarstan, Respublika
Russian Federation FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500) Moscow Moskva
Russian Federation FSCC of Special Types of Med. Care and Technologies ( Site 1503) Moscow Moskva
Russian Federation Medical Rehabilitation Center ( Site 1502) Moscow Moskva
Russian Federation A. Tsyb Medical Radiological Research Center ( Site 1513) Obninsk Kaluzskaja Oblast
Russian Federation City Clinical Oncology Center ( Site 1505) Saint Petersburg Sankt-Peterburg
Russian Federation National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504) Saint-Petersburg Sankt-Peterburg
Russian Federation Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507) Ufa Baskortostan, Respublika
South Africa Cancercare ( Site 1706) Cape Town Western Cape
South Africa Groote Schuur Hospital ( Site 1704) Cape Town Gauteng
South Africa The Oncology Centre ( Site 1709) Durban Kwazulu-Natal
South Africa Outeniqua Cancercare Oncology Unit ( Site 1708) George Western Cape
South Africa Wits Clinical Research ( Site 1702) Johannesburg Gauteng
South Africa Cape Town Oncology Trials Pty Ltd ( Site 1707) Kraaifontein Western Cape
South Africa Cancer Care Langenhoven Drive Oncology Centre ( Site 1701) Port Elizabeth Eastern Cape
South Africa Curo Oncology ( Site 1710) Pretoria Gauteng
South Africa Department of Medical Oncology ( Site 1703) Pretoria Gauteng
South Africa Little Company of Mary Hospital ( Site 1700) Pretoria Gauteng
South Africa Wilgers Oncology Centre ( Site 1705) Pretoria Gauteng
South Africa Sandton Oncology Medical Group PTY LTD ( Site 1712) Sandton Gauteng
Spain Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608) A Coruna La Coruna
Spain Hospital Provincial San Pedro de Alcantara ( Site 1607) Caceres
Spain Hospital Universitario de Donostia ( Site 1602) Donostia Gipuzkoa
Spain Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603) Hospitalet de Llobregat Barcelona
Spain Hospital Universitario Lucus Augusti ( Site 1609) Lugo
Spain Clinica Universitaria de Navarra ( Site 1600) Madrid
Spain Xarxa Assistencial Universitaria Manresa ( Site 1605) Manresa Barcelona
Spain Hospital Universitario Virgen del Rocio ( Site 1604) Sevilla
Spain Hospital de Terrassa ( Site 1606) Terrassa Barcelona
Spain Hospital General Universitario de Valencia ( Site 1610) Valencia Valenciana, Comunitat
Spain Instituto Valenciano de Oncologia ( Site 1601) Valencia Valenciana, Comunitat
Taiwan Changhua Christian Hospital ( Site 2507) Changhua
Taiwan China Medical University Hospital ( Site 2506) Taichung
Taiwan Taichung Veterans General Hospital ( Site 2510) Taichung
Taiwan National Cheng Kung University Hospital ( Site 2508) Tainan
Taiwan MacKay Memorial Hospital ( Site 2500) Taipei
Taiwan National Taiwan University Hospital ( Site 2502) Taipei
Taiwan Taipei Veterans General Hospital ( Site 2503) Taipei
Taiwan Linkou Chang Gung Memorial Hospital ( Site 2501) Taoyuan
Turkey Ankara UTF Cebeci Arastirma ve Uygulama Hastanesi ( Site 1905) Ankara
Turkey Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903) Ankara
Turkey Akdeniz Universitesi Tip Fakultesi ( Site 1901) Antalya
Turkey Uludag Universitesi Tip Fakultesi ( Site 1904) Bursa
Turkey Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907) Istanbul
Turkey Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900) Istanbul
Turkey Medipol Universite Hastanesi ( Site 1909) Istanbul
Turkey Istanbul Acibadem University Atakent Hospital ( Site 1902) Kucukcekmece Istanbul
Turkey Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906) Sakarya
Ukraine MI Precarpathian Clinical Oncology Center ( Site 2181) Ivano-Frankivsk Ivano-Frankivska Oblast
Ukraine Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180) Kharkiv Kharkivska Oblast
Ukraine Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli Khmelnytskyi Khmelnytska Oblast
Ukraine Kyiv City Clinical Oncological Center ( Site 2140) Kyiv
Ukraine Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170) Lviv Lvivska Oblast
Ukraine MI Odessa Regional Oncological Centre ( Site 2121) Odesa Odeska Oblast
Ukraine RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191) Sumy Sumska Oblast
Ukraine Central City Clinical Hospital ( Site 2150) Uzhgorod Zakarpatska Oblast
United States Emory School of Medicine ( Site 0053) Atlanta Georgia
United States Weinberg Cancer Institute at Franklin Square ( Site 0035) Baltimore Maryland
United States Texas Oncology, P.A. - Bedford ( Site 8005) Bedford Texas
United States University of Alabama at Birmingham (UAB) ( Site 0036) Birmingham Alabama
United States Disney Family Cancer Center ( Site 0042) Burbank California
United States MD Anderson Cancer Center at Cooper ( Site 0067) Camden New Jersey
United States Miami Valley Hospital [Dayton, OH] ( Site 0073) Centerville Ohio
United States Rush University Medical Center ( Site 0019) Chicago Illinois
United States University of Chicago ( Site 0049) Chicago Illinois
United States Oncology/Hematology Care Clinical Trials, LLC ( Site 8001) Cincinnati Ohio
United States The Bing Cancer Center ( Site 0044) Columbus Ohio
United States Parkland Hospital ( Site 0081) Dallas Texas
United States Texas Oncology-Dallas Presbyterian Hospital ( Site 8004) Dallas Texas
United States UT Southwestern Medical Center ( Site 0046) Dallas Texas
United States Sanford Roger Maris Cancer Center ( Site 0082) Fargo North Dakota
United States Northeast Georgia Medical Center ( Site 0029) Gainesville Georgia
United States Virginia Cancer Specialists, PC ( Site 8003) Gainesville Virginia
United States OSU Wexner Medical Center ( Site 0076) Hilliard Ohio
United States Dr. Sudarshan K. Sharma, LTD ( Site 0061) Hinsdale Illinois
United States Saint Vincent Hospital and Health Center ( Site 0012) Indianapolis Indiana
United States University of Iowa Hospital and Clinics ( Site 0005) Iowa City Iowa
United States Saint Dominic - Jackson Memorial Hospital ( Site 0072) Jackson Mississippi
United States Northwell Health- Monter Cancer Center ( Site 0075) Lake Success New York
United States Dartmouth Hitchcock Medical Center ( Site 0024) Lebanon New Hampshire
United States University of Kentucky ( Site 0045) Lexington Kentucky
United States MEDICAL COLLEGE OF WISCONSIN ( Site 0064) Milwaukee Wisconsin
United States Smilow Cancer Center at Yale-New Haven ( Site 0057) New Haven Connecticut
United States Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077) Oakland California
United States Nebraska Methodist Hospital ( Site 0063) Omaha Nebraska
United States Women and Infants Hospital [Providence, RI] ( Site 0039) Providence Rhode Island
United States Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084) Roseville California
United States Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083) Sacramento California
United States Washington University - School of Medicine ( Site 0062) Saint Louis Missouri
United States Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078) San Francisco California
United States Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079) Santa Clara California
United States Sarasota Memorial Hospital ( Site 0023) Sarasota Florida
United States Memorial Health University Medical Center ( Site 0011) Savannah Georgia
United States Sanford Gynecology Oncology ( Site 0004) Sioux Falls South Dakota
United States Holy Name Medical Center ( Site 0037) Teaneck New Jersey
United States University of Arizona Cancer Center ( Site 0074) Tucson Arizona
United States Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006) Tyler Texas
United States Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008) Vallejo California
United States Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080) Walnut Creek California

Sponsors (3)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Czechia,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  South Africa,  Spain,  Taiwan,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to approximately 57 months
Primary 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. Up to approximately 57 months
Secondary 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. Up to approximately 6 years
Secondary 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). Up to approximately 6 years
Secondary 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. Up to approximately 57 months
Secondary 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. Up to approximately 57 months
Secondary 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. Up to approximately 78 months
Secondary 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. Up to approximately 78 months
Secondary 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. Up to approximately 73 months
Secondary 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. Up to approximately 6 years
Secondary 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. Baseline and End of Study Participation (Up to approximately 6 years)
Secondary 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. Baseline and End of Study Participation (Up to approximately 6 years)
Secondary 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. Up to approximately 6 years
Secondary 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. Up to approximately 6 years
Secondary 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. Up to approximately 6 years
Secondary 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. Up to approximately 6 years
Secondary 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. Up to approximately 6 years
Secondary 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. Up to approximately 30 months
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