Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)
- Conditions
- Ovarian CancerCarcinoma, Ovarian EpithelialFallopian Tube Neoplasms
- Interventions
- Other: Placebo for pembrolizumab
- Registration Number
- NCT05116189
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score \[CPS\] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 616
- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Has received 1 or 2 prior lines of systemic therapy for ovarian cancer (OC), including at least 1 prior platinum-based therapy. Participants may have received a prior poly (ADP-ribose) polymerase inhibitor (PARPi), anti-PD-1/anti-PD-L1 therapy, bevacizumab, or hormonal therapy; these will not be considered a separate line of therapy. Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.
- Has provided documented informed consent for the study.
- Has radiographic evidence of disease progression within 6 months (180 days) after the last dose of platinum-based chemotherapy for OC (i.e., platinum-resistant disease).
- Is a candidate for paclitaxel chemotherapy (and bevacizumab, if using).
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 3 days before randomization.
- For a female participant, she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and uses a contraceptive method that is highly effective (with a failure rate of <1% per year).
- Has radiographically evaluable disease, either measurable or nonmeasurable per RECIST 1.1, as assessed by the local site investigator.
- Archival tumor tissue sample or newly obtained core or incisional/excisional biopsy of a tumor lesion not previously irradiated has been provided.
- Have adequate organ function.
- Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.
- Has primary platinum-refractory disease, defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of first-line platinum-based therapy.
- Has prior disease progression on weekly paclitaxel alone.
- Has received >2 prior lines of systemic therapy for OC.
- Has received prior systemic anticancer therapy including investigational agents or maintenance therapy (including bevacizumab maintenance therapy), within 4 weeks before randomization.
- Has received prior radiation therapy within 2 weeks of start of study intervention.
- Has not recovered adequately from surgery and/or any complications from the surgery.
- Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor,[GM-CSF] or recombinant erythropoietin) within 4 weeks before randomization.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Has received investigational agent or has used an investigational device within 4 weeks prior to study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab, paclitaxel, or bevacizumab (if using) and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in the 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 a known history of Hepatitis B or known active Hepatitis C virus infection.
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Participant, in the judgement of the investigator, is unlikely to comply with the study procedures, restrictions, and requirements of the study.
- Has had an allogenic tissue/solid organ transplant.
For bevacizumab treatment
- Has uncontrolled hypertension.
- Has current, clinically relevant bowel obstruction including related to underlying epithelial OC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.
- Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab + paclitaxel ± bevacizumab Pembrolizumab Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Placebo + paclitaxel ± bevacizumab Placebo for pembrolizumab Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Pembrolizumab + paclitaxel ± bevacizumab Paclitaxel Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Pembrolizumab + paclitaxel ± bevacizumab Bevacizumab Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Pembrolizumab + paclitaxel ± bevacizumab Docetaxel Participants receive pembrolizumab 400 mg via intravenous (IV) infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Placebo + paclitaxel ± bevacizumab Paclitaxel Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Placebo + paclitaxel ± bevacizumab Bevacizumab Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion. Placebo + paclitaxel ± bevacizumab Docetaxel Participants receive placebo via IV infusion for eighteen 6-week cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator Up to ~38 months 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 presented.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to ~64 months 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.
PFS per RECIST 1.1 by Blinded Independent Central Review (BICR) Up to ~38 months 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 presented.
Number of Participants who Experience an Adverse Event (AE) Up to ~64 months An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants who Discontinue Study Treatment due to an AE Up to ~64 months 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.
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Baseline and up to ~64 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.
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30 Up to ~64 months TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale Baseline and up to ~64 months The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" 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 abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale Up to ~64 months TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
Trial Locations
- Locations (187)
University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)
🇺🇸Worcester, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)
🇺🇸Hackensack, New Jersey, United States
BC Cancer Victoria ( Site 0513)
🇨🇦Victoria, British Columbia, Canada
MetroHealth Medical Center-Cancer Care Center ( Site 0047)
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)
🇺🇸Pittsburgh, Pennsylvania, United States
Erasmus Medisch Centrum-Medical Oncology ( Site 1803)
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Roswell Park Cancer Institute ( Site 0039)
🇺🇸Buffalo, New York, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0027)
🇺🇸Fort Wayne, Indiana, United States
WK Physicians Network / Hematology Oncology Associates ( Site 0034)
🇺🇸Shreveport, Louisiana, United States
Aultman Hospital-Oncology Clinical Trials ( Site 0009)
🇺🇸Canton, Ohio, United States
ANIMI - Unidade de Tratamento Oncologico ( Site 0408)
🇧🇷Lages, Santa Catarina, Brazil
Columbia University Medical Center ( Site 0010)
🇺🇸New York, New York, United States
Texas Oncology - Dallas (Presbyterian) ( Site 0065)
🇺🇸Dallas, Texas, United States
Charité Campus Virchow-Klinikum ( Site 1201)
🇩🇪Berlin, Germany
Emek Medical Center-Gyn-Onc ( Site 1406)
🇮🇱Afula, Israel
Soroka Medical Center ( Site 1404)
🇮🇱Be'er Sheva, Israel
Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)
🇩🇪Leipzig, Sachsen, Germany
Sheba Medical Center ( Site 1407)
🇮🇱Ramat Gan, Israel
Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)
🇩🇪Hamburg, Germany
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)
🇳🇱Utrecht, Netherlands
St. James's Hospital-Cancer clinical trials office ( Site 2821)
🇮🇪Dublin, Ireland
Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)
🇳🇴Tromsø, Troms, Norway
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)
🇮🇹Milan, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)
🇮🇹Milan, Milano, Italy
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)
🇷🇺Moscow, Moskva, Russian Federation
Rabin Medical Center ( Site 1401)
🇮🇱Petah-Tikva, Israel
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)
🇰🇷Seoul, Korea, Republic of
Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)
🇮🇹Monza, Lombardia, Italy
Aichi Cancer Center Hospital ( Site 1610)
🇯🇵Nagoya, Aichi, Japan
Gangnam Severance Hospital ( Site 2301)
🇰🇷Seoul, Korea, Republic of
COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)
🇲🇽Mexico City, Distrito Federal, Mexico
iCan Oncology Center Centro Medico AVE ( Site 1704)
🇲🇽Monterrey, Nuevo Leon, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1705)
🇲🇽Oaxaca, Mexico
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)
🇳🇱Leiden, Zuid-Holland, Netherlands
Addenbrooke's Hospital ( Site 2808)
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)
🇮🇹Brescia, Italy
Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)
🇩🇪Krefeld, Nordrhein-Westfalen, Germany
Seoul National University Hospital ( Site 2302)
🇰🇷Seoul, Korea, Republic of
Sourasky Medical Center ( Site 1403)
🇮🇱Tel Aviv, Israel
Hokkaido University Hospital ( Site 1604)
🇯🇵Sapporo, Hokkaido, Japan
Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)
🇲🇽La Paz, Baja California Sur, Mexico
Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)
🇮🇱Haifa, Israel
Shaare Zedek Medical Center ( Site 1405)
🇮🇱Jerusalem, Israel
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur
🇩🇪Dresden, Sachsen, Germany
cukurova universty ( Site 2706)
🇹🇷Sarçam, Adana, Turkey
Ninewells Hospital and Medical School ( Site 2826)
🇬🇧Dundee, Dundee City, United Kingdom
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)
🇵🇱Kielce, Swietokrzyskie, Poland
Ehime University Hospital ( Site 1606)
🇯🇵Toon, Ehime, Japan
Shizuoka Cancer Center ( Site 1611)
🇯🇵Nagaizumi, Shizuoka, Japan
Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary
🇷🇺Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)
🇲🇽Mexico City, Distrito Federal, Mexico
The Royal Cornwall Hospital ( Site 2804)
🇬🇧Truro, Cornwall, United Kingdom
Hammersmith Hospital-Medical Oncology ( Site 2818)
🇬🇧London, London, City Of, United Kingdom
Osaka International Cancer Institute ( Site 1602)
🇯🇵Osaka, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1603)
🇯🇵Matsuyama, Ehime, Japan
Ogarev Mordovia State University ( Site 2209)
🇷🇺Saransk, Mordoviya, Respublika, Russian Federation
Radboudumc ( Site 1802)
🇳🇱Nijmegen, Gelderland, Netherlands
Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)
🇵🇱Warsaw, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit
🇵🇱Warszawa, Mazowieckie, Poland
Auckland City Hospital ( Site 1901)
🇳🇿Auckland, New Zealand
Baskent Universitesi Ankara Hastanesi ( Site 2707)
🇹🇷Ankara, Turkey
Velindre Cancer Centre ( Site 2805)
🇬🇧Cardiff, United Kingdom
Moscow City Oncology Hospital #62 ( Site 2214)
🇷🇺Krasnogorsk D-t, Moskovskaya Oblast, Russian Federation
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
🇵🇱Gdańsk, Pomorskie, Poland
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit
🇵🇱Poznan, Wielkopolskie, Poland
Istanbul Universitesi Cerrahpasa ( Site 2709)
🇹🇷Fatih, Istanbul, Turkey
Brighton and Sussex University Hospitals NHS Trust ( Site 2803)
🇬🇧East Sussex, Brighton And Hove, United Kingdom
St. Vincent Hospital and Health Care Center, Inc ( Site 0032)
🇺🇸Indianapolis, Indiana, United States
Duke Cancer Institute ( Site 0038)
🇺🇸Durham, North Carolina, United States
St. John of God Subiaco Hospital ( Site 0203)
🇦🇺Subiaco, Western Australia, Australia
Ege University Medicine of Faculty ( Site 2702)
🇹🇷Bornova, Izmir, Turkey
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)
🇧🇷Natal, Rio Grande Do Norte, Brazil
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)
🇫🇷Limoges, Haute-Vienne, France
CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)
🇩🇪Saarbrücken, Saarland, Germany
Beijing Cancer hospital ( Site 0711)
🇨🇳Beijing, Beijing, China
Lanzhou university second hospital ( Site 0734)
🇨🇳Lanzhou, Gansu, China
Shandong Cancer Hospital-Oncology Department ( Site 0733)
🇨🇳Jinan, Shandong, China
Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)
🇨🇳Wenzhou, Zhejiang, China
Aalborg Universitetshospital, Syd ( Site 0901)
🇩🇰Aalborg, Nordjylland, Denmark
HonorHealth ( Site 0041)
🇺🇸Phoenix, Arizona, United States
Providence Portland Medical Center ( Site 0048)
🇺🇸Portland, Oregon, United States
Kurume University Hospital ( Site 1607)
🇯🇵Kurume, Fukuoka, Japan
Nippon Medical School Musashi Kosugi Hospital ( Site 1614)
🇯🇵Kawasaki, Kanagawa, Japan
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)
🇹🇷Adana, Turkey
Ankara University Hospital Cebeci ( Site 2701)
🇹🇷Ankara, Turkey
Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)
🇹🇷Istanbul, Turkey
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma
🇹🇷Istanbul, Turkey
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)
🇧🇷Rio de Janeiro, Brazil
Sarasota Memorial Hospital ( Site 0018)
🇺🇸Sarasota, Florida, United States
Marin Cancer Care ( Site 0055)
🇺🇸Greenbrae, California, United States
Pacific Cancer Care ( Site 0028)
🇺🇸Monterey, California, United States
Eisenhower Medical Center ( Site 0067)
🇺🇸Rancho Mirage, California, United States
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054
🇺🇸Gainesville, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)
🇺🇸Marietta, Georgia, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)
🇺🇸Edgewood, Kentucky, United States
Advocate Medical Group-Oncology ( Site 0049)
🇺🇸Park Ridge, Illinois, United States
Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)
🇺🇸Baltimore, Maryland, United States
Novant Health Presbyterian Medical Center ( Site 0029)
🇺🇸Charlotte, North Carolina, United States
The West Clinic, PLLC dba West Cancer Center ( Site 0058)
🇺🇸Germantown, Tennessee, United States
Texas Oncology - The Woodlands_Lee ( Site 0043)
🇺🇸The Woodlands, Texas, United States
Inova Schar Cancer Institute ( Site 0019)
🇺🇸Fairfax, Virginia, United States
Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)
🇦🇺Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0204)
🇦🇺Melbourne, Victoria, Australia
UZ Leuven ( Site 0303)
🇧🇪Leuven, Vlaams-Brabant, Belgium
Hospital Araújo Jorge ( Site 0401)
🇧🇷Goiânia, Goias, Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)
🇧🇷São Paulo, Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)
🇧🇷São Paulo, Sao Paulo, Brazil
Tom Baker Cancer Center ( Site 0511)
🇨🇦Calgary, Alberta, Canada
BC Cancer Abbotsford ( Site 0512)
🇨🇦Abbotsford, British Columbia, Canada
Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog
🇨🇦Kingston, Ontario, Canada
Jewish General Hospital ( Site 0505)
🇨🇦Montreal, Quebec, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre ( Site 0502)
🇨🇦Montréal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
🇨🇦Quebec, Canada
James Lind Centro de Investigación del Cáncer ( Site 0602)
🇨🇱Temuco, Araucania, Chile
Oncovida ( Site 0603)
🇨🇱Santiago, Region M. De Santiago, Chile
Instituto de Radiomedicina-hemato-oncologia ( Site 0604)
🇨🇱Santiago, Region M. De Santiago, Chile
Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)
🇨🇳Hefei, Anhui, China
Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)
🇨🇳Beijing, Beijing, China
Fujian Provincial Cancer Hospital ( Site 0713)
🇨🇳Fuzhou, Fujian, China
Zhujiang Hospital ( Site 0739)
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University ( Site 0743)
🇨🇳Zhanjiang, Guangdong, China
Hainan General Hospital ( Site 0736)
🇨🇳Haikou, Hainan, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)
🇨🇳Nanning, Guangxi, China
Henan Cancer Hospital ( Site 0718)
🇨🇳Zhengzhou, Henan, China
Wuhan Union Hospital-Medical Oncology ( Site 0735)
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University-Gynecology ( Site 0705)
🇨🇳Changsha, Hunan, China
Hunan Cancer Hospital ( Site 0704)
🇨🇳Changsha, Hunan, China
Zhongda Hospital Southeast University ( Site 0723)
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (
🇨🇳Nanjing, Jiangsu, China
Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University ( Site 0710)
🇨🇳Changchun, Jilin, China
LinYi Cancer Hospital ( Site 0731)
🇨🇳Linyi, Shandong, China
Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)
🇨🇳Shanghai, Shanghai, China
Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)
🇨🇳Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)
🇨🇳Shanghai, Shanghai, China
West China Second University Hospital Sichuan University ( Site 0740)
🇨🇳Chengdu, Sichuan, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)
🇨🇳Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital ( Site 0720)
🇨🇳Tianjin, Tianjin, China
The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)
🇨🇳Hangzhou, Zhejiang, China
Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)
🇨🇴Medellin, Antioquia, Colombia
Clínica Universitaria Colombia ( Site 0806)
🇨🇴Bogotá, Distrito Capital De Bogota, Colombia
Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)
🇨🇴Barranquilla, Atlantico, Colombia
Oncologos del Occidente ( Site 0807)
🇨🇴Pereira, Risaralda, Colombia
Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi
🇫🇷Brest, Bretagne, France
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)
🇫🇮Turku, Varsinais-Suomi, Finland
Centre de Cancérologie du Grand Montpellier ( Site 2908)
🇫🇷Montpellier, Languedoc-Roussillon, France
Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)
🇫🇷Nantes, Loire-Atlantique, France
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)
🇩🇪Erlangen, Bayern, Germany
National Cancer Center Hospital East ( Site 1609)
🇯🇵Kashiwa, Chiba, Japan
IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)
🇮🇹Bologna, Emilia-Romagna, Italy
Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)
🇮🇹Torino, Piemonte, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)
🇮🇹Milano, Italy
Iwate Medical University Hospital ( Site 1613)
🇯🇵Shiwa-gun Yahaba-cho, Iwate, Japan
National Cancer Center Hospital ( Site 1612)
🇯🇵Chuo-ku, Tokyo, Japan
Saitama Medical University International Medical Center ( Site 1601)
🇯🇵Hidaka-shi, Saitama, Japan
Japanese Foundation for Cancer Research ( Site 1605)
🇯🇵Koto, Tokyo, Japan
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)
🇰🇷Seoul, Korea, Republic of
Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)
🇬🇧Leicester, England, United Kingdom
Westmorland General Hospital ( Site 2815)
🇬🇧Kendal, Cumbria, United Kingdom
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)
🇨🇦Toronto, Ontario, Canada
Sanford Cancer Center ( Site 0064)
🇺🇸Sioux Falls, South Dakota, United States
Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)
🇦🇺Westmead, New South Wales, Australia
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)
🇷🇺Ekaterinburg, Sverdlovskaya Oblast, Russian Federation
UZ Gent-Medical oncology ( Site 0301)
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)
🇧🇪Kortrijk, West-Vlaanderen, Belgium
CIDO SpA-Oncology ( Site 0608)
🇨🇱Temuco, Araucania, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)
🇨🇱Santiago, Region M. De Santiago, Chile
Institut Jules Bordet-Medicine Oncology ( Site 0302)
🇧🇪Bruxelles, Bruxelles-Capitale, Region De, Belgium
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)
🇫🇷Rennes, Ille-et-Vilaine, France
Hemato Oncologos SA ( Site 0801)
🇨🇴Cali, Valle Del Cauca, Colombia
Clínica Puerto Montt ( Site 0601)
🇨🇱Puerto Montt, Los Lagos, Chile
Clínica Vespucio-Hemato - Ocology ( Site 0607)
🇨🇱Santiago, Region M. De Santiago, Chile
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21
🇵🇱Gliwice, Slaskie, Poland
Saskatoon Cancer Center ( Site 0510)
🇨🇦Saskatoon, Saskatchewan, Canada
Institut Curie - site Saint-Cloud ( Site 2909)
🇫🇷Saint-Cloud, Hauts-de-Seine, France
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)
🇵🇱Bialystok, Podlaskie, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)
🇵🇱Bialystok, Podlaskie, Poland
Bradfordhill ( Site 0605)
🇨🇱Santiago, Region M. De Santiago, Chile
Centre François Baclesse-Recherche clinique ( Site 2904)
🇫🇷Caen, Calvados, France
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)
🇺🇸New Haven, Connecticut, United States
Moffitt Cancer Center ( Site 0033)
🇺🇸Tampa, Florida, United States
Novant Health Forsyth Medical Center ( Site 0057)
🇺🇸Winston-Salem, North Carolina, United States