Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)
- Conditions
- Endometrial Neoplasms
- Interventions
- Registration Number
- NCT05173987
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.
The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 280
-
Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
-
Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
-
Has received no prior systemic therapy for EC except for the following:
- May have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent resection if the recurrence occurred ≥6 months after the last dose of chemotherapy.
- May have received prior radiation with or without radiosensitizing chemotherapy if >2 weeks before the start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- May have received prior hormonal therapy for treatment of EC, provided that it was discontinued ≥1 week prior to randomization.
-
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
-
Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
-
Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
-
Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
-
If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
-
If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.
- Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas and neuroendocrine tumors are not allowed.
- Has EC of any histology that is proficient mismatch repair (pMMR).
- Is a candidate for curative-intent surgery or curative-intent radiotherapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137]).
- Has received prior systemic anticancer therapy including investigational agents for any advanced or metastatic EC. (Note: Prior chemotherapy administered as adjuvant therapy, neoadjuvant therapy, and/or concurrently with radiation is permitted.
- Has had a major operation and has not recovered adequately from the procedure and/or any complications from the operation before starting study intervention.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Is currently participating in or has participated in a study of an investigational agent for EC, has participated in a study of an investigational agent for non-EC within 4 weeks before the first dose of study intervention, or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a known intolerance to any study intervention and/or any of its excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection, requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has had an allogenic tissue/solid organ transplant.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab pembrolizumab Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (up to approximately 2 years). Carboplatin+paclitaxel carboplatin Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation. Carboplatin+paclitaxel paclitaxel Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation. Carboplatin+paclitaxel docetaxel Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation. Carboplatin+paclitaxel cisplatin Participants receive a combination of paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle (Q3W) and carboplatin AUC 5 or 6 on Day 1 Q3W for 6 cycles (up to approximately 4 months). Participants who experience a severe hypersensitivity reaction to paclitaxel or an adverse event (AE) requiring discontinuation of paclitaxel may receive docetaxel 75 mg/m\^2 in place of paclitaxel on Day 1 Q3W after Sponsor consultation. Participants who experience a severe hypersensitivity reaction to carboplatin or an AE requiring discontinuation of carboplatin may receive cisplatin 75 mg/m\^2 in place of carboplatin on Day 1 Q3W after Sponsor consultation.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 45 months PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 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 BICR will be reported for participants.
Overall Survival Up to approximately 59 months OS is defined as the time from randomization to death due to any cause. The OS will be reported for all participants.
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 45 months DOR is defined as the time from first documented evidence of CR or PR until the first documented date of disease progression (PD) or death due to any cause, whichever occurs first, for participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Number of Participants Who Experience at Least One Adverse Event (AE) Up to approximately 27 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported.
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 45 months DCR is defined, per RECIST 1.1, as the percentage of participants who have achieved Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or demonstrated Stable Disease (SD) for at least 24 weeks. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.) The DCR as assessed by BICR will be presented.
Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Up to approximately 45 months PFS is defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 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 investigator will be reported for participants.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) Up to approximately 45 months ORR is defined as the percentage of participants who have a best response of confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Progression-Free Survival 2 (PFS2) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Up to approximately 45 months PFS2 is defined as the time from randomization to subsequent disease progression (PD) per RECIST 1.1 after initiation of a new anticancer therapy, 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 PFS2 per RECIST 1.1 as assessed by investigator will be reported for participants.
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Combined Score Baseline and up to approximately 25 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Up to approximately 24 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Change From Baseline in European Organization for Research And Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) (Item 29) And Quality of Life (QoL) (Item 30) Combined Score Baseline and up to approximately 25 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "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?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Trial Locations
- Locations (195)
Northside Hospital ( Site 0017)
🇺🇸Atlanta, Georgia, United States
St. Dominic's Hospital ( Site 0024)
🇺🇸Jackson, Mississippi, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0026)
🇺🇸Hackensack, New Jersey, United States
FirstHealth Clinical Trials ( Site 0050)
🇺🇸Pinehurst, North Carolina, United States
Sanford Medical Center ( Site 0054)
🇺🇸Bismarck, North Dakota, United States
Sidney Kimmel Cancer Center - Jefferson Health ( Site 0053)
🇺🇸Philadelphia, Pennsylvania, United States
Princess Margaret Cancer Centre ( Site 0510)
🇨🇦Toronto, Ontario, Canada
AHN West Penn Hospital ( Site 0011)
🇺🇸Pittsburgh, Pennsylvania, United States
Maryland Oncology Hematology, P.A.-USOR Maryland Oncology Hematology, P.A. ( Site 8002)
🇺🇸Rockville, Maryland, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
🇺🇸Columbus, Ohio, United States
Texas Oncology - Tyler-USOR Texas Oncology - Northeast Texas ( Site 8004)
🇺🇸Tyler, Texas, United States
VCU Health Adult Outpatient Pavillion ( Site 0022)
🇺🇸Richmond, Virginia, United States
Northern Cancer Institute ( Site 0206)
🇦🇺St Leonards, New South Wales, Australia
St. John of God Subiaco Hospital-Oncology Clinical Trials Unit ( Site 0204)
🇦🇺Subiaco, Western Australia, Australia
Saskatoon Cancer Center-Clinical Research Department ( Site 0520)
🇨🇦Saskatoon, Saskatchewan, Canada
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0604)
🇨🇱Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0730)
🇨🇳Hefei, Anhui, China
Southwest Hospital of Third Military Medical University ( Site 0719)
🇨🇳Chongqing, Chongqing, China
Hunan Cancer Hospital ( Site 0709)
🇨🇳Changsha, Hunan, China
Shaanxi Provincial Cancer Hospital ( Site 0714)
🇨🇳XI An, Shaanxi, China
The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0726)
🇨🇳Hangzhou, Zhejiang, China
West China Second University Hospital Sichuan University ( Site 0701)
🇨🇳Chengdu, Sichuan, China
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 0405)
🇨🇿Praha, Praha 2, Czechia
Nemocnice Tomase Bati ve Zline-Onkologické oddělení ( Site 0407)
🇨🇿Zlín, Zlinsky Kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady-Gynekologicko-porodnická klinika ( Site 0408)
🇨🇿Praha 10, Czechia
Tampereen yliopistollinen sairaala-Gynecology and Obstetrics ( Site 1001)
🇫🇮Tampere, Pirkanmaa, Finland
Universitätsklinikum Bonn-Gynaecological oncology ( Site 1105)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Universitaetsklinikum Ulm ( Site 1106)
🇩🇪Ulm, Baden-Wurttemberg, Germany
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1702)
🇳🇱Leiden, Zuid-Holland, Netherlands
Erasmus Medisch Centrum-Medical Oncology ( Site 1701)
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2406)
🇪🇸Hospitalet, Barcelona, Spain
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
🇵🇱Poznan, Wielkopolskie, Poland
COMPLEJO HOSPITALARIO DE NAVARRA ( Site 2407)
🇪🇸Pamplona, Navarra, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2405)
🇪🇸A Coruña, La Coruna, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2404)
🇪🇸Valencia, Valenciana, Comunitat, Spain
National Taiwan University Hospital ( Site 2603)
🇨🇳Taipei, Taiwan
Istanbul Universitesi Cerrahpasa ( Site 2702)
🇹🇷Fatih, Istanbul, Turkey
The Christie ( Site 2807)
🇬🇧Manchester, England, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 2808)
🇬🇧London, London, City Of, United Kingdom
Peking University First Hospital ( Site 0723)
🇨🇳Beijing, Beijing, China
Harbin Medical University Cancer Hospital ( Site 0711)
🇨🇳Harbin, Heilongjiang, China
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 3005)
🇧🇷Natal, Rio Grande Do Norte, Brazil
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0055)
🇺🇸Fargo, North Dakota, United States
Rigshospitalet ( Site 0903)
🇩🇰Copenhagen, Hovedstaden, Denmark
Aalborg Universitetshospital, Syd ( Site 0905)
🇩🇰Aalborg, Nordjylland, Denmark
Roskilde Sygehus-Oncology department ( Site 0904)
🇩🇰Roskilde, Sjaelland, Denmark
HonorHealth-USOR HonorHealth ( Site 8000)
🇺🇸Phoenix, Arizona, United States
Karmanos Cancer Institute ( Site 0029)
🇺🇸Detroit, Michigan, United States
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 150
🇮🇹Milan, Lombardia, Italy
IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1503)
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 1514)
🇮🇹Torino, Piemonte, Italy
Istituto Nazionale Tumori Regina Elena-Oncologia Medica 1 ( Site 1504)
🇮🇹Rome, Roma, Italy
Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1509)
🇮🇹Firenze, Toscana, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1506)
🇮🇹Milano, Italy
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2704)
🇹🇷Ankara, Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2706)
🇹🇷Ankara, Turkey
Providence Portland Medical Center ( Site 0031)
🇺🇸Portland, Oregon, United States
Kaiser Permanente Riverside Medical Center ( Site 0045)
🇺🇸Riverside, California, United States
Midwestern Regional Medical Center,Inc. DBA CTCA, Chicago ( Site 0003)
🇺🇸Zion, Illinois, United States
Mount Sinai Cancer Center ( Site 0018)
🇺🇸Miami Beach, Florida, United States
Memorial Sloan Kettering Cancer Center ( Site 0009)
🇺🇸New York, New York, United States
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0023)
🇺🇸New York, New York, United States
University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0039)
🇺🇸Cincinnati, Ohio, United States
Texas Oncology - Austin-USOR Texas Oncology - Austin ( Site 8003)
🇺🇸Austin, Texas, United States
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
🇦🇺Brisbane, Queensland, Australia
Grand Hôpital de Charleroi-Oncology & Hematology ( Site 0323)
🇧🇪Charleroi, Hainaut, Belgium
Monash Health ( Site 0202)
🇦🇺Clayton, Victoria, Australia
Institut Jules Bordet-Medicine Oncology ( Site 0321)
🇧🇪Bruxelles, Bruxelles-Capitale, Region De, Belgium
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 3001)
🇧🇷São Paulo, Sao Paulo, Brazil
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0320)
🇧🇪Liège, Liege, Belgium
A. C. Camargo Cancer Center-CAPEC ( Site 3003)
🇧🇷Sao Paulo, Brazil
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0509)
🇨🇦Toronto, Ontario, Canada
FALP-UIDO ( Site 0602)
🇨🇱Santiago, Region M. De Santiago, Chile
Centre Hospitalier de l'Université de Montréal ( Site 0519)
🇨🇦Montréal, Quebec, Canada
Beijing Obstetric and Gynecology Hospital ( Site 0740)
🇨🇳Beijing, Beijing, China
Jewish General Hospital ( Site 0504)
🇨🇦Montreal, Quebec, Canada
Bradfordhill-Clinical Area ( Site 0603)
🇨🇱Santiago, Region M. De Santiago, Chile
Beijing Cancer hospital ( Site 0715)
🇨🇳Beijing, Beijing, China
2nd Affiliated Hospital Chongqing Medical Universi ( Site 0745)
🇨🇳Chongqing, Chongqing, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 0710)
🇨🇳Guangzhou, Guangdong, China
Fuling Central Hospital ( Site 0733)
🇨🇳Fulingqu, Chongqing, China
Hainan General Hospital ( Site 0703)
🇨🇳Haikou, Hainan, China
Cancer Hospital of Shantou University Medical College ( Site 0732)
🇨🇳Shantou, Guangdong, China
Fujian Provincial Cancer Hospital ( Site 0720)
🇨🇳Fuzhou, Fujian, China
Affiliated Hospital of Guangdong Medical College ( Site 0731)
🇨🇳Zhanjiang, Guangdong, China
Henan Cancer Hospital ( Site 0713)
🇨🇳Zhengzhou, Henan, China
Guangxi Medical University Affiliated Tumor Hospital-Gynecological oncology ( Site 0704)
🇨🇳Nanning, Guangxi, China
Xiangya Hospital Central South University-Gynecology ( Site 0708)
🇨🇳Changsha, Hunan, China
Wuhan Union Hospital-Medical Oncology ( Site 0716)
🇨🇳Wuhan, Hubei, China
Jiangsu Province Hospital-Oncology Department ( Site 0707)
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University ( Site 0729)
🇨🇳Nanchang, Jiangxi, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 0702)
🇨🇳Shanghai, Shanghai, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 0721)
🇨🇳Kunming, Yunnan, China
The First Hospital of Jilin University ( Site 0705)
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0725)
🇨🇳Wenzhou, Zhejiang, China
Binzhou Medical University Hospital-Oncology department ( Site 0735)
🇨🇳Binzhou, Shandong, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0717)
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0706)
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital-Oncology ( Site 0700)
🇨🇳Hangzhou, Zhejiang, China
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0402)
🇨🇿Olomouc, Olomoucky Kraj, Czechia
Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 0406)
🇨🇿Nový Jiín, Novy Jicin, Czechia
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1003)
🇫🇮Helsinki, Uusimaa, Finland
Herlev and Gentofte Hospital ( Site 0902)
🇩🇰Copenhagen, Hovedstaden, Denmark
Charité Campus Virchow-Klinikum ( Site 1103)
🇩🇪Berlin, Germany
Kuopion Yliopistollinen Sairaala ( Site 1002)
🇫🇮Kuopio, Pohjois-Savo, Finland
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
🇩🇪Dresden, Sachsen, Germany
Bon Secours Cork Hospital ( Site 1305)
🇮🇪Cork, Ireland
Shaare Zedek Medical Center ( Site 1404)
🇮🇱Jerusalem, Israel
Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
🇮🇱Haifa, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1513)
🇮🇹Meldola, Emilia-Romagna, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 1
🇮🇹Napoli, Campania, Italy
National Hospital Organization Shikoku Cancer Center ( Site 1611)
🇯🇵Matsuyama, Ehime, Japan
National Cancer Center Hospital East ( Site 1604)
🇯🇵Kashiwa, Chiba, Japan
Hokkaido University Hospital ( Site 1601)
🇯🇵Sapporo, Hokkaido, Japan
Ehime University Hospital ( Site 1614)
🇯🇵Toon, Ehime, Japan
Iwate Medical University Hospital ( Site 1602)
🇯🇵Shiwa-gun Yahaba-cho, Iwate, Japan
Niigata University Medical & Dental Hospital ( Site 1613)
🇯🇵Chuo-ku, Niigata, Niigata, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1608)
🇯🇵Fukuoka, Japan
Tsukuba University Hospital ( Site 1618)
🇯🇵Tsukuba, Ibaraki, Japan
Japanese Foundation for Cancer Research ( Site 1616)
🇯🇵Koto, Tokyo, Japan
University Medical Center Groningen ( Site 1707)
🇳🇱Groningen, Netherlands
Catharina Ziekenhuis-Oncology ( Site 1704)
🇳🇱Eindhoven, Noord-Brabant, Netherlands
Oslo universitetssykehus, Radiumhospitalet ( Site 1901)
🇳🇴Oslo, Norway
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2301)
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital ( Site 2304)
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital ( Site 2302)
🇰🇷Seoul, Korea, Republic of
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2303)
🇰🇷Seoul, Korea, Republic of
Maastricht UMC+ ( Site 1709)
🇳🇱Maastricht, Limburg, Netherlands
Amsterdam UMC, locatie AMC ( Site 1706)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Centrum Onkologii Ziemi Lubelskiej ( Site 2006)
🇵🇱Lublin, Lubelskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2007)
🇵🇱Siedlce, Mazowieckie, Poland
Auckland City Hospital-Cancer & Blood Research ( Site 1801)
🇳🇿Auckland, New Zealand
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
🇵🇱Warszawa, Mazowieckie, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2003)
🇵🇱Bialystok, Podlaskie, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 20
🇵🇱Gliwice, Slaskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2010)
🇵🇱Kielce, Swietokrzyskie, Poland
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2402)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitari Vall d'Hebron ( Site 2403)
🇪🇸Barcelona, Spain
Yaroslavl Regional Cancer Hospital-Oncology ( Site 2202)
🇷🇺Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Moscow City Oncology Hospital #62 ( Site 2204)
🇷🇺Krasnogorsk, Moskovskaya Oblast, Russian Federation
Karolinska Universitetssjukhuset Solna ( Site 2502)
🇸🇪Solna, Stockholms Lan, Sweden
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 2401)
🇪🇸Sevilla, Spain
Skånes Universitetssjukhus Lund-Department of Hematology ( Site 2504)
🇸🇪Lund, Skane Lan, Sweden
Taichung Veterans General Hospital ( Site 2602)
🇨🇳Taichung, Taiwan
NATIONAL CHENG-KUNG UNI. HOSP. ( Site 2604)
🇨🇳Tainan, Taiwan
Norrlands universitetssjukhus-Cancercentrum ( Site 2503)
🇸🇪Umeå, Vasterbottens Lan, Sweden
Istanbul University Capa Campus-department of obstetrics and gynaecology ( Site 2705)
🇹🇷Istanbul, Turkey
St Bartholomew's Hospital ( Site 2804)
🇬🇧London, England, United Kingdom
Akdeniz Universitesi Hastanesi ( Site 2701)
🇹🇷Antalya, Turkey
Taipei Veterans General Hospital ( Site 2605)
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital ( Site 2601)
🇨🇳Taipei, Taiwan
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2806)
🇬🇧London, London, City Of, United Kingdom
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
🇹🇷Istanbul, Turkey
The Beatson West of Scotland Cancer Centre ( Site 2805)
🇬🇧Glasgow, Glasgow City, United Kingdom
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0016)
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai ( Site 0052)
🇺🇸New York, New York, United States
Moores Cancer Center ( Site 0037)
🇺🇸La Jolla, California, United States
Sarasota Memorial Hospital ( Site 0005)
🇺🇸Sarasota, Florida, United States
St. Vincent Hospital and Health Care Center, Inc ( Site 0006)
🇺🇸Indianapolis, Indiana, United States
Baptist Health Lexington ( Site 0042)
🇺🇸Lexington, Kentucky, United States
University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 0008)
🇺🇸Worcester, Massachusetts, United States
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0034)
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology - Dallas-USOR Texas Oncology - Dallas (Sammons) ( Site 8005)
🇺🇸Dallas, Texas, United States
Asplundh Cancer Pavilion ( Site 0014)
🇺🇸Willow Grove, Pennsylvania, United States
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 0403)
🇨🇿Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 0401)
🇨🇿Praha, Praha 8, Czechia
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
🇦🇺Westmead, New South Wales, Australia
Southeastern Regional Medical Center ( Site 0046)
🇺🇸Newnan, Georgia, United States
Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 0404)
🇨🇿Brno, Brno-mesto, Czechia
Soroka Medical Center ( Site 1403)
🇮🇱Be'er Sheva, Israel
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 1502)
🇮🇹Roma, Lazio, Italy
Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2009)
🇵🇱Warsaw, Mazowieckie, Poland
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0013)
🇺🇸New Haven, Connecticut, United States
Keio university hospital ( Site 1606)
🇯🇵Shinjyuku-ku, Tokyo, Japan
Gunma Prefectural Cancer Center-Gynecology ( Site 1603)
🇯🇵Ota, Gunma, Japan
Sanford Cancer Center-Gynecologic Oncology ( Site 0002)
🇺🇸Sioux Falls, South Dakota, United States
The Jikei University Hospital ( Site 1615)
🇯🇵Minato-ku, Tokyo, Japan
McGill University Health Centre ( Site 0505)
🇨🇦Montréal, Quebec, Canada
Cross Cancer Institute ( Site 0513)
🇨🇦Edmonton, Alberta, Canada
St. James's Hospital-Cancer clinical trials office ( Site 1301)
🇮🇪Dublin, Ireland
Edith Wolfson Medical Center-Obstetrics & Gynecology ( Site 1405)
🇮🇱Holon, Israel
Shizuoka Cancer Center ( Site 1609)
🇯🇵Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital ( Site 1607)
🇯🇵Chuo-ku, Tokyo, Japan
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1705)
🇳🇱Utrecht, Netherlands
BC Cancer Vancouver-Clinical Trials Unit ( Site 0518)
🇨🇦Vancouver, British Columbia, Canada
AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 1510)
🇮🇹Vicenza, Veneto, Italy
Sheba Medical Center ( Site 1401)
🇮🇱Ramat Gan, Israel
Kurume University Hospital ( Site 1612)
🇯🇵Kurume, Fukuoka, Japan
Saitama Medical University International Medical Center ( Site 1605)
🇯🇵Hidaka-shi, Saitama, Japan
Osaka International Cancer Institute ( Site 1617)
🇯🇵Osaka, Japan
BC Cancer Kelowna ( Site 0517)
🇨🇦Kelowna, British Columbia, Canada
Radboudumc-Medical Oncology ( Site 1703)
🇳🇱Nijmegen, Gelderland, Netherlands
Országos Onkológiai Intézet-Ngyógyászat ( Site 1201)
🇭🇺Budapest, Hungary
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0207)
🇦🇺Melbourne, Victoria, Australia
Epworth Freemasons ( Site 0203)
🇦🇺Melbourne, Victoria, Australia