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)

Last updated: November 15, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Fallopian Tube Cancer

Pelvic Cancer

Digestive System Neoplasms

Treatment

Olaparib

Placebo for olaparib

Carboplatin

Clinical Study ID

NCT03740165
7339-001
MK-7339-001
KEYLYNK-001
ENGOT-ov43
194619
GOG-3036
2018-001973-25
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (anygrade), carcinosarcoma, mixed mullerian with high-grade serous component, clearcell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer

  • Has just completed primary debulking surgery or is eligible for primary debulkingsurgery or is a potential candidate for interval debulking surgery

  • Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered inthe 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 forprospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumormarkers status prior to randomization

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, asassessed within 7 days prior to initiating chemotherapy in the lead-in period andwithin 3 days prior to Day 1 of Cycle 1

  • Female participants are not pregnant, not breastfeeding, and at least 1 of thefollowing conditions applies: a.) Not a woman of childbearing potential (WOCBP) ORb.) Is a WOCBP and using a contraceptive method that is highly effective, with lowuser dependency, or be abstinent from heterosexual intercourse as their preferredand usual lifestyle, during the Treatment Period and for at least 120 days followingthe last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (ifadministered), at least 180 days following the last dose of olaparib (or olaparibplacebo), and at least 210 days following the last dose of chemotherapy and agreesnot to donate eggs (ova, oocytes) to others or freeze/store for her own use for thepurpose of reproduction during this period. The investigator should evaluate thepotential for contraceptive method failure in relationship to the first dose ofstudy treatment. A WOCBP must have a negative highly sensitive pregnancy test withineither 24 hours (urine) or 72 hours (serum) before the first dose of studytreatment. If a urine test cannot be confirmed as negative, a serum pregnancy testis required. The investigator is responsible for review of medical history,menstrual history, and recent sexual activity to decrease the risk for inclusion ofa woman with an early undetected pregnancy. Contraceptive use by women should beconsistent with local regulations regarding the methods of contraception for thoseparticipating in clinical studies

  • Has adequate organ function

Exclusion

Exclusion Criteria:

  • Has mucinous, germ cell, or borderline tumor of the ovary

  • Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1or BRCA2

  • Has a history of non-infectious pneumonitis that required treatment with steroids orcurrently has pneumonitis

  • Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or hasfeatures suggestive of MDS/AML

  • Has a known additional malignancy that is progressing or has required activetreatment in the last 3 years Note: Participants with basal cell carcinoma of theskin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductalcarcinoma in situ, cervical carcinoma in situ) that has undergone potentiallycurative therapy are not excluded.

  • Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapyadministered 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 previouslytreated (except with chemotherapy) and are radiologically stable, clinically stable,and no steroids were used for the management of symptoms related to brain metastaseswithin 14 days prior to randomization. Stable brain metastases should be establishedprior 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 ofimmunosuppressive therapy within 7 days prior to randomization

  • Has an active autoimmune disease that has required systemic treatment in the past 2years (i.e., with use of disease modifying agents, corticosteroids orimmunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, orphysiologic corticosteroid replacement therapy for adrenal or pituitaryinsufficiency) 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 recombinanterythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-inperiod

  • Is considered to be of poor medical risk due to a serious, uncontrolled medicaldisorder, non-malignant systemic disease or active, uncontrolled infection

  • Has had surgery to treat borderline tumors, early stage EOC, or early stagefallopian 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] isdetected) infection. Testing for hepatitis B or hepatitis C is required at screeningonly if mandated by local health authority. Note: Participants with a history ofhepatitis 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-occlusivedisease), abdominal fistula or GI perforation, related to underlying EOC (forparticipants receiving bevacizumab)

  • Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months priorto randomization (for participants receiving bevacizumab)

  • Is a WOCBP who has a positive urine pregnancy test within 72 hours before the firstdose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 ofCycle 1, is pregnant or breastfeeding, or is expecting to conceive children withinthe projected duration of the study, starting with screening through 120 daysfollowing the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (orolaparib placebo), and at least 210 days following the last dose of chemotherapy

  • Has received prior treatment for any stage of OC, including radiation or systemicanti-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 orco-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-linetherapy

  • Has received a live vaccine within 30 days prior to the first dose of studytreatment 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 discontinuedfor the duration of the study

  • Is currently participating or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks (28 days) of startingchemotherapy in the Lead-in Period

  • Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversiblecardiac conditions or participant has congenital long QT syndrome

  • Has had an allogenic tissue/solid organ transplant, has received previous allogenicbone-marrow transplant, or has received double umbilical cord transplantation

  • Either has had major surgery within 3 weeks of randomization or has not recoveredfrom any effects of any major surgery

Study Design

Total Participants: 1367
Treatment Group(s): 8
Primary Treatment: Olaparib
Phase: 3
Study Start date:
December 18, 2018
Estimated Completion Date:
May 29, 2026

Study 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.

Connect with a study center

  • St George Hospital ( Site 2207)

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Cairns and Hinterland Hospital and Health Service ( Site 2201)

    Cairns, Queensland 4870
    Australia

    Site Not Available

  • Ballarat Health Services ( Site 2202)

    Ballarat, Victoria 3350
    Australia

    Site Not Available

  • Monash Health ( Site 2204)

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Sunshine Hospital. ( Site 2205)

    St Albans, Victoria 3021
    Australia

    Site Not Available

  • Imelda Ziekenhuis Bonheiden ( Site 0301)

    Bonheiden, Antwerpen 1932
    Belgium

    Site Not Available

  • UZ Leuven Campus Gasthuisberg ( Site 0306)

    Leuven, Antwerpen 3000
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc ( Site 0312)

    Brussels, Bruxelles-Capitale, Region De 1200
    Belgium

    Site Not Available

  • Grand Hopital de Charleroi ( Site 0302)

    Charleroi, Hainaut 6000
    Belgium

    Site Not Available

  • CHU de Liege ( Site 0310)

    Liège, Liege 4000
    Belgium

    Site Not Available

  • Jessa Ziekenhuis ( Site 0309)

    Hasselt, Limburg 3500
    Belgium

    Site Not Available

  • Centre Hospitalier de l'Ardenne ( Site 0303)

    Libramont, Luxembourg 6800
    Belgium

    Site Not Available

  • AZ Maria Middelares Gent ( Site 0300)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Gent ( Site 0307)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • CHU de Liege ( Site 0310)

    Liege, 4000
    Belgium

    Site Not Available

  • Instituto do Cancer do Ceara ( Site 2707)

    Fortaleza, Ceara 60430-230
    Brazil

    Site Not Available

  • Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2708)

    Goiania, Goias 74605-070
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner ( Site 2716)

    Curitiba, Parana 82520-060
    Brazil

    Site Not Available

  • Hospital de Caridade de Ijui ( Site 2712)

    Ijui, Rio Grande Do Sul 98700-000
    Brazil

    Site Not Available

  • Hospital Bruno Born ( Site 2704)

    Lajeado, Rio Grande Do Sul 95900-000
    Brazil

    Site Not Available

  • Hospital Nossa Senhora Da Conceicao ( Site 2703)

    Porto Alegre, Rio Grande Do Sul 91350-200
    Brazil

    Site Not Available

  • Instituto Nacional de Cancer Hospital do Cancer II ( Site 2700)

    Rio de Janeiro, 20220-410
    Brazil

    Site Not Available

  • Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706)

    Sao Paulo, 01317-000
    Brazil

    Site Not Available

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2714)

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2710)

    Sao Paulo, 01321-001
    Brazil

    Site Not Available

  • Tom Baker Cancer Centre ( Site 0200)

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Kingston Health Sciences Centre ( Site 0207)

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • The Credit Valley Hospital ( Site 0206)

    Mississauga, Ontario L5M 2N1
    Canada

    Site Not Available

  • Princess Margaret Hospital.. ( Site 0202)

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • CIUSSS du Saguenay-Lac-St-Jean ( Site 0218)

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0219)

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0208)

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Royal Victoria Hospital McGill University Health Centre ( Site 0211)

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Centro Investigación del Cáncer James Lind ( Site 2810)

    Temuco, Araucania 4780000
    Chile

    Site Not Available

  • Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 2808)

    Temuco, Araucania 4810218
    Chile

    Site Not Available

  • Fundacion Arturo Lopez Perez FALP ( Site 2800)

    Santiago, Region M. De Santiago 7500922
    Chile

    Site Not Available

  • Iram Cancer Research ( Site 2809)

    Santiago, Region M. De Santiago 7630370
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile ( Site 2805)

    Santiago, Region M. De Santiago 8330032
    Chile

    Site Not Available

  • Sociedad Oncovida S.A. ( Site 2807)

    Santiago, Region M. De Santiago 7510032
    Chile

    Site Not Available

  • Oncocentro ( Site 2801)

    Vina del Mar, Valparaiso 2520598
    Chile

    Site Not Available

  • Centro Oncologico Antofagasta ( Site 2804)

    Antofagasta, 1240000
    Chile

    Site Not Available

  • Biomelab S A S ( Site 2900)

    Barranquilla, Atlantico 080002
    Colombia

    Site Not Available

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2913)

    Valledupar, Cesar 200001
    Colombia

    Site Not Available

  • Oncomedica S.A. ( Site 2911)

    Monteria, Cordoba 230002
    Colombia

    Site Not Available

  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2912)

    Bogota, Distrito Capital De Bogota 111321
    Colombia

    Site Not Available

  • Instituto Nacional de Cancerologia E.S.E ( Site 2910)

    Bogota, Distrito Capital De Bogota 110321
    Colombia

    Site Not Available

  • Centro Medico Imbanaco de Cali S.A ( Site 2909)

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Hemato Oncologos S.A. ( Site 2906)

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Fakultni nemocnice Brno ( Site 0404)

    Brno, Brno-mesto 602 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava ( Site 0403)

    Ostrava-Poruba, Moravskoslezsky Kraj 708 52
    Czechia

    Site Not Available

  • Nemocnice Na Bulovce ( Site 0401)

    Praha, Praha, Hlavni Mesto 180 81
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze ( Site 0400)

    Praha, Praha, Hlavni Mesto 120 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc ( Site 0402)

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Hopital Prive Jean Mermoz ( Site 0607)

    Lyon, Auvergne 69008
    France

    Site Not Available

  • Centre Paul Strauss ( Site 0615)

    Strasbourg, Bas-Rhin 67065
    France

    Site Not Available

  • Hopital de la Timone ( Site 0617)

    Marseille, Bouches-du-Rhone 13005
    France

    Site Not Available

  • CHU de Brest -Site Hopital Morvan ( Site 0616)

    Brest, Bretagne 29200
    France

    Site Not Available

  • Institut de Cancerologie du Gard - CHU Caremeau ( Site 0610)

    Nimes, Gard 30029
    France

    Site Not Available

  • Institut de Cancerologie Lucien Neuwirth ( Site 0613)

    Saint-Priest-en-Jarez, Loire 42270
    France

    Site Not Available

  • Centre D Oncologie de Gentilly ( Site 0609)

    Nancy, Meurthe-et-Moselle 54100
    France

    Site Not Available

  • Institut Gustave Roussy ( Site 0600)

    Villejuif, Val-de-Marne 94800
    France

    Site Not Available

  • Hopital Tenon ( Site 0612)

    Paris, 75020
    France

    Site Not Available

  • Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0707)

    Stuttgart, Baden-Wurttemberg 70199
    Germany

    Site Not Available

  • Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0710)

    Muenchen, Bayern 72074
    Germany

    Site Not Available

  • Uniklinik RWTH Aachen ( Site 0718)

    Aachen, Nordrhein-Westfalen 52074
    Germany

    Site Not Available

  • Gynaekologisches Zentrum ( Site 0712)

    Bonn, Nordrhein-Westfalen 53111
    Germany

    Site Not Available

  • Klinikum Dortmund gGmbH ( Site 0717)

    Dortmund, Nordrhein-Westfalen 44137
    Germany

    Site Not Available

  • Universitaetsklinikum Duesseldorf ( Site 0704)

    Duesseldorf, Nordrhein-Westfalen 40225
    Germany

    Site Not Available

  • HELIOS Klinikum Krefeld ( Site 0715)

    Krefeld, Nordrhein-Westfalen 47805
    Germany

    Site Not Available

  • Universitaetsklinikum Muenster ( Site 0720)

    Muenster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Caritas Klinikum Saarbruecken St. Theresia ( Site 0702)

    Saarbruecken, Saarland 66113
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH ( Site 0711)

    Chemnitz, Sachsen 09116
    Germany

    Site Not Available

  • Staedtisches Krankenhaus Kiel GmbH ( Site 0709)

    Kiel, Schleswig-Holstein 24116
    Germany

    Site Not Available

  • Charite Campus Virchow-Klinikum - CVK ( Site 0700)

    Berlin, 13353
    Germany

    Site Not Available

  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 0805)

    Pecs, Baranya 7624
    Hungary

    Site Not Available

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz ( Site 0802)

    Miskolc, Borsod-Abauj-Zemplen 1051
    Hungary

    Site Not Available

  • Orszagos Onkologiai Intezet ( Site 0800)

    Budapest, 1122
    Hungary

    Site Not Available

  • Uzsoki Utcai Korhaz ( Site 0803)

    Budapest, 1145
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont ( Site 0801)

    Debrecen, 4032
    Hungary

    Site Not Available

  • Soroka Medical Center ( Site 1006)

    Beer-Sheva, 8410101
    Israel

    Site Not Available

  • Hillel Yaffe Medical Center ( Site 1011)

    Hadera, 3810101
    Israel

    Site Not Available

  • Carmel Medical Center ( Site 1007)

    Haifa, 3436212
    Israel

    Site Not Available

  • Rambam Medical Center ( Site 1002)

    Haifa, 3525408
    Israel

    Site Not Available

  • Edith Wolfson Medical Center ( Site 1003)

    Holon, 5822012
    Israel

    Site Not Available

  • Shaare Zedek Medical Center ( Site 1005)

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Rabin Medical Center ( Site 1004)

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Chaim Sheba Medical Center ( Site 1000)

    Ramat Gan, 5262000
    Israel

    Site Not Available

  • Sourasky Medical Center ( Site 1001)

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1108)

    Bari, Abruzzo 70124
    Italy

    Site Not Available

  • Istituto Europeo di Oncologia ( Site 1100)

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • A.O.U. Citta della Salute e della Scienza di Torino ( Site 1104)

    Torino, Piemonte 10126
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS ( Site 1113)

    Padova, Veneto 35128
    Italy

    Site Not Available

  • Sacro Cuore di Gesu Fatebenefratelli ( Site 1112)

    Benevento, 82100
    Italy

    Site Not Available

  • Ospedale Cannizzaro ( Site 1110)

    Catania, 95126
    Italy

    Site Not Available

  • ASST Lecco. Ospedale A. Manzoni ( Site 1101)

    Lecco, 23900
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1115)

    Milano, 20133
    Italy

    Site Not Available

  • A.O.U. Federico II di Napoli ( Site 1107)

    Napoli, 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Policlinico Umberto I ( Site 1111)

    Roma, 00161
    Italy

    Site Not Available

  • Policlinico Universitario Gemelli ( Site 1105)

    Roma, 00168
    Italy

    Site Not Available

  • Presidio Ospedaliero Santa Chiara ( Site 1109)

    Trento, 38122
    Italy

    Site Not Available

  • A.O. Univ. S. M. della Misericordia ( Site 1114)

    Udine, 33100
    Italy

    Site Not Available

  • National Cancer Center Hospital East ( Site 2602)

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • National Hospital Organization Shikoku Cancer Center ( Site 2601)

    Matsuyama, Ehime 791-0280
    Japan

    Site Not Available

  • Ehime University Hospital ( Site 2600)

    Toon, Ehime 791-0295
    Japan

    Site Not Available

  • Gunma Prefectural Cancer Center ( Site 2609)

    Ota, Gunma 373-8550
    Japan

    Site Not Available

  • Hokkaido University Hospital ( Site 2607)

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Iwate Medical University Hospital ( Site 2606)

    Morioka, Iwate 020-8505
    Japan

    Site Not Available

  • Iwate Medical University Hospital ( Site 2606)

    Shiwa-gun, Iwate 028-3695
    Japan

    Site Not Available

  • St. Marianna University School of Medicine Hospital ( Site 2613)

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • University of the Ryukyus Hospital ( Site 2616)

    Nakagami-gun, Okinawa 903-0215
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center ( Site 2604)

    Hidaka, Saitama 350-1298
    Japan

    Site Not Available

  • Saitama Cancer Center ( Site 2614)

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Site Not Available

  • National Defense Medical College Hospital ( Site 2608)

    Tokorozawa, Saitama 359-8513
    Japan

    Site Not Available

  • Kyorin University Hospital ( Site 2610)

    Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • Kagoshima City Hospital ( Site 2612)

    Kagoshima, 890-8760
    Japan

    Site Not Available

  • Niigata Cancer Center Hospital ( Site 2618)

    Niigata, 951-8566
    Japan

    Site Not Available

  • Osaka International Cancer Institute ( Site 2617)

    Osaka, 541-8567
    Japan

    Site Not Available

  • National Cancer Center Hospital ( Site 2605)

    Tokyo, 104-0045
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital ( Site 2404)

    Seongnam-si, Kyonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center ( Site 2402)

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center ( Site 2401)

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital ( Site 2403)

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System ( Site 2400)

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1404)

    Warsaw, Mazowieckie 02-781
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Bialostockie Centrum Onkologii ( Site 1412)

    Bialystok, Podlaskie 15-027
    Poland

    Site Not Available

  • Szpitale Pomorskie Sp. z o.o. ( Site 1407)

    Gdynia, Pomorskie 81-519
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1406)

    Gliwice, Slaskie 44-102
    Poland

    Site Not Available

  • Swietokrzyskie Centrum Onkologii SPZOZ ( Site 1410)

    Kielce, Swietokrzyskie 25-734
    Poland

    Site Not Available

  • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

    Poznan, Wielkopolskie 61-848
    Poland

    Site Not Available

  • Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1412)

    Białystok, 15-027
    Poland

    Site Not Available

  • Arkhangelsk Clinical Oncological Dispensary ( Site 1508)

    Arkhangelsk, Arkhangel Skaya Oblast 163045
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)

    Ufa, Baskortostan, Respublika 450054
    Russian Federation

    Site Not Available

  • A. Tsyb Medical Radiological Research Center ( Site 1513)

    Obninsk, Kaluzskaja Oblast 249036
    Russian Federation

    Site Not Available

  • FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1500)

    Moscow, Moskva 115478
    Russian Federation

    Site Not Available

  • FSCC of Special Types of Med. Care and Technologies ( Site 1503)

    Moscow, Moskva 115682
    Russian Federation

    Site Not Available

  • Medical Rehabilitation Center ( Site 1502)

    Moscow, Moskva 125367
    Russian Federation

    Site Not Available

  • City Clinical Oncology Center ( Site 1505)

    Saint Petersburg, Sankt-Peterburg 198255
    Russian Federation

    Site Not Available

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

    Saint-Petersburg, Sankt-Peterburg 197758
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1509)

    Kazan, Tatarstan, Respublika 420029
    Russian Federation

    Site Not Available

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1504)

    St. Petersburg, 197758
    Russian Federation

    Site Not Available

  • Cancer Care Langenhoven Drive Oncology Centre ( Site 1701)

    Port Elizabeth, Eastern Cape 6045
    South Africa

    Site Not Available

  • Groote Schuur Hospital ( Site 1704)

    Cape Town, Gauteng 7925
    South Africa

    Site Not Available

  • Wits Clinical Research ( Site 1702)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Wits Clinical Research ( Site 1702)

    Parktown-Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Curo Oncology ( Site 1710)

    Pretoria, Gauteng 0031
    South Africa

    Site Not Available

  • Department of Medical Oncology ( Site 1703)

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Little Company of Mary Hospital ( Site 1700)

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Wilgers Oncology Centre ( Site 1705)

    Pretoria, Gauteng 0081
    South Africa

    Site Not Available

  • Sandton Oncology Medical Group PTY LTD ( Site 1712)

    Sandton, Gauteng 2196
    South Africa

    Site Not Available

  • Umhlanga Oncolgy Center ( Site 1709)

    Umhlanga, KZN 4320
    South Africa

    Site Not Available

  • The Oncology Centre ( Site 1709)

    Durban, Kwazulu-Natal 4091
    South Africa

    Site Not Available

  • Cancercare ( Site 1706)

    Cape Town, Western Cape 7700
    South Africa

    Site Not Available

  • Outeniqua Cancercare Oncology Unit ( Site 1708)

    George, Western Cape 6530
    South Africa

    Site Not Available

  • Cape Town Oncology Trials Pty Ltd ( Site 1707)

    Kraaifontein, Western Cape 7570
    South Africa

    Site Not Available

  • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1603)

    Hospitalet de Llobregat, Barcelona 08909
    Spain

    Site Not Available

  • Xarxa Assistencial Universitaria Manresa ( Site 1605)

    Manresa, Barcelona 08243
    Spain

    Site Not Available

  • Hospital de Terrassa ( Site 1606)

    Terrassa, Barcelona 08227
    Spain

    Site Not Available

  • Hospital Universitario de Donostia ( Site 1602)

    Donostia, Gipuzkoa 20014
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

    A Coruna, La Coruna 15006
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia ( Site 1610)

    Valencia, Valenciana, Comunitat 46014
    Spain

    Site Not Available

  • Instituto Valenciano de Oncologia ( Site 1601)

    Valencia, Valenciana, Comunitat 46009
    Spain

    Site Not Available

  • Hospital Provincial San Pedro de Alcantara ( Site 1607)

    Caceres, 10003
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1608)

    La Coruna, 15006
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti ( Site 1609)

    Lugo, 27003
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra ( Site 1600)

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario de Donostia ( Site 1602)

    San Sebastian, 20014
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio ( Site 1604)

    Sevilla, 41013
    Spain

    Site Not Available

  • Changhua Christian Hospital ( Site 2507)

    Changhua, 50006
    Taiwan

    Site Not Available

  • China Medical University Hospital ( Site 2506)

    Taichung, 40447
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital ( Site 2510)

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 2508)

    Tainan, 704
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital ( Site 2500)

    Taipei, 10449
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 2502)

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital ( Site 2503)

    Taipei, 11217
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital ( Site 2501)

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Istanbul Acibadem University Atakent Hospital ( Site 1902)

    Kucukcekmece, Istanbul 34303
    Turkey

    Site Not Available

  • Ankara UTF Cebeci Arastırma ve Uygulama Hastanesi ( Site 1905)

    Ankara, 06590
    Turkey

    Site Not Available

  • Etlik Zubeyde Hanim Kadin Hastaliklari Egitim ve Arastirma Hastanesi ( Site 1903)

    Ankara, 06050
    Turkey

    Site Not Available

  • Akdeniz Universitesi Tıp Fakultesi ( Site 1901)

    Antalya, 07070
    Turkey

    Site Not Available

  • Uludag Universitesi Tip Fakultesi ( Site 1904)

    Bursa, 16059
    Turkey

    Site Not Available

  • Bakirkoy Sadi Konuk Egitim ve Arastirma Hastanesi ( Site 1907)

    Istanbul, 34147
    Turkey

    Site Not Available

  • Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1900)

    Istanbul, 34093
    Turkey

    Site Not Available

  • Medipol Universite Hastanesi ( Site 1909)

    Istanbul, 34214
    Turkey

    Site Not Available

  • Sakarya Universitesi Tip Fakultesi Hastanesi ( Site 1906)

    Sakarya, 54290
    Turkey

    Site Not Available

  • MI Precarpathian Clinical Oncology Center ( Site 2181)

    Ivano-Frankivsk, Ivano-Frankivska Oblast 76018
    Ukraine

    Site Not Available

  • Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 2180)

    Kharkiv, Kharkivska Oblast 61024
    Ukraine

    Site Not Available

  • Municipal non-profit Enterprise Khmelnytskyi Regional Antitu-Gynecological Oncology department, Poli

    Khmelnytskyi, Khmelnytska Oblast 29009
    Ukraine

    Site Not Available

  • Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2170)

    Lviv, Lvivska Oblast 79031
    Ukraine

    Site Not Available

  • MI Odessa Regional Oncological Centre ( Site 2121)

    Odesa, Odeska Oblast 65055
    Ukraine

    Site Not Available

  • RMI - Sumy Regional Clinical Oncology Dispensary ( Site 2191)

    Sumy, Sumska Oblast 40022
    Ukraine

    Site Not Available

  • Central City Clinical Hospital ( Site 2150)

    Uzhgorod, Zakarpatska Oblast 88000
    Ukraine

    Site Not Available

  • Khmelnytskyi Regional Hospital ( Site 2190)

    Khmelnitskiy, 29000
    Ukraine

    Site Not Available

  • Kyiv City Clinical Oncological Center ( Site 2140)

    Kyiv, 03115
    Ukraine

    Site Not Available

  • University of Alabama at Birmingham (UAB) ( Site 0036)

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Arizona Cancer Center ( Site 0074)

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Disney Family Cancer Center ( Site 0042)

    Burbank, California 91505
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trial -Oakland ( Site 0077)

    Oakland, California 94611
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trials-Roseville ( Site 0084)

    Roseville, California 95661
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trials-Sacramento ( Site 0083)

    Sacramento, California 95814
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trial - San Francisco ( Site 0078)

    San Francisco, California 94115
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trial - Santa Clara ( Site 0079)

    Santa Clara, California 95051
    United States

    Site Not Available

  • Kaiser Permanente N. CA Regional Oncology Clinical Trials ( Site 0008)

    Vallejo, California 94589
    United States

    Site Not Available

  • Kaiser Permanente Oncology Clinical Trial - Walnut Creek ( Site 0080)

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Smilow Cancer Center at Yale-New Haven ( Site 0057)

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Sarasota Memorial Hospital ( Site 0023)

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Emory School of Medicine ( Site 0053)

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northeast Georgia Medical Center ( Site 0029)

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • Memorial Health University Medical Center ( Site 0011)

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Rush University Medical Center ( Site 0019)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Rush University Medical Center_Do not use - Duplicate facility ( Site 0019)

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Chicago ( Site 0049)

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Dr. Sudarshan K. Sharma, LTD ( Site 0061)

    Hinsdale, Illinois 60521
    United States

    Site Not Available

  • Saint Vincent Hospital and Health Center ( Site 0012)

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • University of Iowa Hospital and Clinics ( Site 0005)

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky ( Site 0045)

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Weinberg Cancer Institute at Franklin Square ( Site 0035)

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Saint Dominic - Jackson Memorial Hospital ( Site 0072)

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Washington University - School of Medicine ( Site 0062)

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Nebraska Methodist Hospital ( Site 0063)

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center ( Site 0024)

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • MD Anderson Cancer Center at Cooper ( Site 0067)

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Holy Name Medical Center ( Site 0037)

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Northwell Health- Monter Cancer Center ( Site 0075)

    Lake Success, New York 11042
    United States

    Site Not Available

  • Sanford Roger Maris Cancer Center ( Site 0082)

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Miami Valley Hospital [Dayton, OH] ( Site 0073)

    Centerville, Ohio 45459
    United States

    Site Not Available

  • Oncology/Hematology Care Clinical Trials, LLC ( Site 8001)

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • The Bing Cancer Center ( Site 0044)

    Columbus, Ohio 43214
    United States

    Site Not Available

  • OSU Wexner Medical Center ( Site 0076)

    Hilliard, Ohio 43026
    United States

    Site Not Available

  • Women and Infants Hospital [Providence, RI] ( Site 0039)

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Sanford Gynecology Oncology ( Site 0004)

    Sioux Falls, South Dakota 57104
    United States

    Site Not Available

  • Texas Oncology, P.A. - Bedford ( Site 8005)

    Bedford, Texas 76022
    United States

    Site Not Available

  • Parkland Hospital ( Site 0081)

    Dallas, Texas 75235
    United States

    Site Not Available

  • Texas Oncology-Dallas Presbyterian Hospital ( Site 8004)

    Dallas, Texas 75231
    United States

    Site Not Available

  • UT Southwestern Medical Center ( Site 0046)

    Dallas, Texas 75390
    United States

    Site Not Available

  • Texas Oncology, P.A. Texas Oncology-Tyler ( Site 8006)

    Tyler, Texas 75702
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC ( Site 8003)

    Gainesville, Virginia 20155
    United States

    Site Not Available

  • MEDICAL COLLEGE OF WISCONSIN ( Site 0064)

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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