Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified February 2026 by Merck Sharp & Dohme LLC
Sponsor
Merck Sharp & Dohme LLC
Information Provided by (Responsible Party)
Merck Sharp & Dohme LLC
Clinicaltrials.gov Identifier
NCT05116189
Other Study ID Numbers:
3475-B96
First Submitted
October 27, 2021
First Posted
November 9, 2021
Results First Posted
February 16, 2026
Last Update Posted
March 8, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Ovarian CancerCarcinoma, Ovarian EpithelialFallopian Tube Neoplasms
Biological: PembrolizumabDrug: Paclitaxel

Study Design

Study TypeInterventional
Actual Enrollment643 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)
Study Start DateDecember 12, 2021
Actual Primary Completion DateMarch 4, 2025
Actual Study Completion Date1yr 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Pembrolizumab + paclitaxel ± bevacizumab
Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 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 adverse event (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.
Biological: Pembrolizumab
IV infusion
Placebo + paclitaxel ± bevacizumab
Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 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 adverse event (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.
Drug: Paclitaxel
IV infusion

Outcome Measures

Primary Outcome Measures
  1. Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)
    PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
  2. PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
    PFS was 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 was 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. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
Secondary Outcome Measures
  1. PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
    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. 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 (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
  2. PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). 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 (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
  3. Overall Survival (OS)
    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.
  4. Number of Participants Who Experience an Adverse Event (AE)
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
  5. Number of Participants Who Discontinue Study Treatment Due to an AE
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
  6. 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)
    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.
  7. Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
    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.
  8. 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
    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.
  9. TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
    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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersNo
Inclusion Criteria
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-programmed cell death 1 protein (PD-1)/anti-programmed cell death ligand 1 (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 Response Evaluation Criteria In Solid Tumors (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.
Exclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsMerck Sharp & Dohme LLC
Locations
HonorHealth ( Site 0041) | Phoenix Arizona, United States, 85016Marin Cancer Care ( Site 0055) | Greenbrae California, United States, 94904Pacific Cancer Care ( Site 0028) | Monterey California, United States, 93940Eisenhower Medical Center ( Site 0067) | Rancho Mirage California, United States, 92270Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004) | New Haven Connecticut, United States, 06511University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054 | Gainesville Florida, United States, 32610Sarasota Memorial Hospital ( Site 0018) | Sarasota Florida, United States, 34239Moffitt Cancer Center ( Site 0033) | Tampa Florida, United States, 33612Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005) | Marietta Georgia, United States, 30060Advocate Medical Group-Oncology ( Site 0049) | Park Ridge Illinois, United States, 60068Parkview Research Center at Parkview Regional Medical Center ( Site 0027) | Fort Wayne Indiana, United States, 46845St. Vincent Hospital and Health Care Center, Inc ( Site 0032) | Indianapolis Indiana, United States, 46260Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040) | Edgewood Kentucky, United States, 41017WK Physicians Network / Hematology Oncology Associates ( Site 0034) | Shreveport Louisiana, United States, 71103Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015) | Baltimore Maryland, United States, 21202University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003) | Worcester Massachusetts, United States, 01605John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007) | Hackensack New Jersey, United States, 07601Roswell Park Cancer Institute ( Site 0039) | Buffalo New York, United States, 14263Columbia University Medical Center ( Site 0010) | New York New York, United States, 10032Novant Health Presbyterian Medical Center ( Site 0029) | Charlotte North Carolina, United States, 28204Duke Cancer Institute ( Site 0038) | Durham North Carolina, United States, 27710Novant Health Forsyth Medical Center ( Site 0057) | Winston-Salem North Carolina, United States, 27103Aultman Hospital-Oncology Clinical Trials ( Site 0009) | Canton Ohio, United States, 44710MetroHealth Medical Center-Cancer Care Center ( Site 0047) | Cleveland Ohio, United States, 44109Providence Portland Medical Center ( Site 0048) | Portland Oregon, United States, 97213University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024) | Pittsburgh Pennsylvania, United States, 15219Sanford Cancer Center ( Site 0064) | Sioux Falls South Dakota, United States, 57104The West Clinic, PLLC dba West Cancer Center ( Site 0058) | Germantown Tennessee, United States, 38138Texas Oncology - Dallas (Presbyterian) ( Site 0065) | Dallas Texas, United States, 75231Texas Oncology - The Woodlands_Lee ( Site 0043) | The Woodlands Texas, United States, 77380Inova Schar Cancer Institute ( Site 0019) | Fairfax Virginia, United States, 22031Westmead Hospital-Department of Gynaecological Oncology ( Site 0201) | Westmead New South Wales, Australia, 2145Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202) | Brisbane Queensland, Australia, 4120Epworth Freemasons ( Site 0204) | Melbourne Victoria, Australia, 3002St. John of God Subiaco Hospital ( Site 0203) | Subiaco Western Australia, Australia, 6008Institut Jules Bordet-Medicine Oncology ( Site 0302) | Brussels Bruxelles-Capitale, Region de, Belgium, 1000UZ Gent-Medical oncology ( Site 0301) | Ghent Oost-Vlaanderen, Belgium, 9000UZ Leuven ( Site 0303) | Leuven Vlaams-Brabant, Belgium, 3000AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305) | Kortrijk West-Vlaanderen, Belgium, 8500Hospital Araújo Jorge ( Site 0401) | Goiânia Goiás, Brazil, 74605-070Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404) | Natal Rio Grande do Norte, Brazil, 59075-740ANIMI - Unidade de Tratamento Oncologico ( Site 0408) | Lages Santa Catarina, Brazil, 88501001BP - A Beneficencia Portuguesa de São Paulo ( Site 0403) | São Paulo São Paulo, Brazil, 01323-001Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405) | São Paulo São Paulo, Brazil, 04014-002Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402) | Rio de Janeiro , Brazil, 20220-410Tom Baker Cancer Center ( Site 0511) | Calgary Alberta, Canada, T2N 4N2BC Cancer Abbotsford ( Site 0512) | Abbotsford British Columbia British Columbia, Canada, V2S 0C2BC Cancer Victoria ( Site 0513) | Victoria British Columbia, Canada, V8R 6V5Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog | Kingston Ontario, Canada, K7L 2V7Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508) | Toronto Ontario, Canada, M4N 3M5CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501) | Montreal Quebec, Canada, H1T 2M4Jewish General Hospital ( Site 0505) | Montreal Quebec, Canada, H3T 1E2McGill University Health Centre ( Site 0502) | Montreal Quebec, Canada, H4A 3J1Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Québec Quebec, Canada, G1J 1Z4Saskatoon Cancer Center ( Site 0510) | Saskatoon Saskatchewan, Canada, S7N 4H4James Lind Centro de Investigación del Cáncer ( Site 0602) | Temuco Araucania, Chile, 4780000CIDO SpA-Oncology ( Site 0608) | Temuco Araucania, Chile, 4810148Clínica Puerto Montt ( Site 0601) | Port Montt Los Lagos Region, Chile, 5500243Oncovida ( Site 0603) | Santiago Region M. de Santiago, Chile, 7510032Instituto de Radiomedicina-hemato-oncologia ( Site 0604) | Santiago Region M. de Santiago, Chile, 7630370Clínica Vespucio-Hemato - Ocology ( Site 0607) | Santiago Region M. de Santiago, Chile, 8241479Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609) | Santiago Region M. de Santiago, Chile, 8330032Bradfordhill ( Site 0605) | Santiago Region M. de Santiago, Chile, 8420383Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709) | Hefei Anhui, China, 230001Beijing Cancer hospital ( Site 0711) | Beijing Beijing Municipality, China, 100142Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702) | Beijing Beijing Municipality, China, 100730Fujian Provincial Cancer Hospital ( Site 0713) | Fuzhou Fujian, China, 350014Lanzhou university second hospital ( Site 0734) | Lanzhou Gansu, China, 730030Zhujiang Hospital ( Site 0739) | Guangzhou Guangdong, China, 510280Affiliated Hospital of Guangdong Medical University ( Site 0743) | Zhanjiang Guangdong, China, 524004Guangxi Medical University Affiliated Tumor Hospital ( Site 0717) | Nanning Guangxi, China, 530021Hainan General Hospital ( Site 0736) | Haikou Hainan, China, 570311Henan Cancer Hospital ( Site 0718) | Zhengzhou Henan, China, 450008Wuhan Union Hospital-Medical Oncology ( Site 0735) | Wuhan Hubei, China, 430022Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708) | Wuhan Hubei, China, 430079Xiangya Hospital Central South University-Gynecology ( Site 0705) | Changsha Hunan, China, 410008Hunan Cancer Hospital ( Site 0704) | Changsha Hunan, China, 410013Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( | Nanjing Jiangsu, China, 210000Zhongda Hospital Southeast University ( Site 0723) | Nanjing Jiangsu, China, Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716) | Nanchang Jiangxi, China, 330006The First Hospital of Jilin University ( Site 0710) | Changchun Jilin, China, 130021Shandong Cancer Hospital-Oncology Department ( Site 0733) | Jinan Shandong, China, 250117LinYi Cancer Hospital ( Site 0731) | Linyi Shandong, China, 276001Obstetrics & Gynecology Hospital of Fudan University ( Site 0715) | Shanghai Shanghai Municipality, China, 200011Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701) | Shanghai Shanghai Municipality, China, 200032Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744) | Shanghai Shanghai Municipality, China, 201204West China Second University Hospital Sichuan University ( Site 0740) | Chengdu Sichuan, China, 610066Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737) | Tianjin Tianjin Municipality, China, 300052Tianjin Medical University Cancer Institute and Hospital ( Site 0720) | Tianjin Tianjin Municipality, China, 300060Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714) | Kunming Yunnan, China, 650106The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741) | Hangzhou Zhejiang, China, 3100000The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706) | Wenzhou Zhejiang, China, 325000Fundación Colombiana de Cancerología Clínica Vida ( Site 0808) | Medellín Antioquia, Colombia, 050030Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809) | Barranquilla Atlántico, Colombia, 080020Clínica Universitaria Colombia ( Site 0806) | Bogotá Bogota D.C., Colombia, 111221Oncologos del Occidente ( Site 0807) | Pereira Risaralda Department, Colombia, 660001Hemato Oncologos SA ( Site 0801) | Cali Valle del Cauca Department, Colombia, 76001Aalborg Universitetshospital, Syd ( Site 0901) | Aalborg North Denmark, Denmark, 9000Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001) | Turku Southwest Finland, Finland, 20521Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi | Brest Brittany Region, France, 29200Centre François Baclesse-Recherche clinique ( Site 2904) | Caen Calvados, France, 14076Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907) | Limoges Haute-Vienne, France, 87042Institut Curie - site Saint-Cloud ( Site 2909) | Saint-Cloud Hauts-de-Seine, France, 92210Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901) | Rennes Ille-et-Vilaine, France, 35042Centre de Cancérologie du Grand Montpellier ( Site 2908) | Montpellier Languedoc-Roussillon, France, 34070Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905) | Nantes Loire-Atlantique, France, 44277Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205) | Erlangen Bavaria, Germany, 91054Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203) | Bonn North Rhine-Westphalia, Germany, 53127Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204) | Düsseldorf North Rhine-Westphalia, Germany, 40225Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207) | Krefeld North Rhine-Westphalia, Germany, 47805CaritasKlinikum Saarbrücken St. Theresia ( Site 1211) | Saarbrücken Saarland, Germany, 66113Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur | Dresden Saxony, Germany, 01307Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213) | Leipzig Saxony, Germany, 04103Charité Campus Virchow-Klinikum ( Site 1201) | Berlin , Germany, 13353Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214) | Hamburg , Germany, 22307St. James's Hospital-Cancer clinical trials office ( Site 2821) | Dublin , Ireland, D08 E9P6Emek Medical Center-Gyn-Onc ( Site 1406) | Afula , Israel, 1834111Soroka Medical Center ( Site 1404) | Beersheba , Israel, 8410101Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402) | Haifa , Israel, 3109601Shaare Zedek Medical Center ( Site 1405) | Jerusalem , Israel, 9103102Rabin Medical Center ( Site 1401) | Petah Tikva , Israel, 49100Sheba Medical Center ( Site 1407) | Ramat Gan , Israel, 5265601Sourasky Medical Center ( Site 1403) | Tel Aviv , Israel, 6423906IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501) | Bologna Emilia-Romagna, Italy, 40138Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503) | Milan Lombardy, Italy, 20133Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508) | Monza Lombardy, Italy, 20900ASST Grande Ospedale Metropolitano Niguarda ( Site 1505) | Milan Milano, Italy, 20162Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507) | Turin Piedmont, Italy, 10128Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504) | Brescia , Italy, 25123Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502) | Milan , Italy, 20141Aichi Cancer Center Hospital ( Site 1610) | Nagoya Aichi-ken, Japan, 464-8681National Cancer Center Hospital East ( Site 1609) | Kashiwa Chiba, Japan, 277-8577National Hospital Organization Shikoku Cancer Center ( Site 1603) | Matsuyama Ehime, Japan, 791-0280Ehime University Hospital ( Site 1606) | Tōon Ehime, Japan, 791-0295Kurume University Hospital ( Site 1607) | Kurume Fukuoka, Japan, 830-0011Hokkaido University Hospital ( Site 1604) | Sapporo Hokkaido, Japan, 060-8648Iwate Medical University Hospital ( Site 1613) | Shiwa-gun Yahaba-cho Iwate, Japan, 028-3695Nippon Medical School Musashi Kosugi Hospital ( Site 1614) | Kawasaki Kanagawa, Japan, 211-8533Saitama Medical University International Medical Center ( Site 1601) | Hidaka-shi Saitama, Japan, 350-1200Shizuoka Cancer Center ( Site 1611) | Nakatogari Shizuoka, Japan, 411-8777National Cancer Center Hospital ( Site 1612) | Chuo-ku Tokyo, Japan, 104-0045Japanese Foundation for Cancer Research ( Site 1605) | Koto Tokyo, Japan, 135-8550Osaka International Cancer Institute ( Site 1602) | Osaka , Japan, 541-8567Investigación Oncofarmacéutica-Investigación clínica ( Site 1706) | La Paz Baja California Sur, Mexico, 23040COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703) | Mexico City Mexico City, Mexico, 04700INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701) | Mexico City Mexico City, Mexico, 14070iCan Oncology Center Centro Medico AVE ( Site 1704) | Monterrey Nuevo León, Mexico, 64710Centro de Investigacion Clinica de Oaxaca ( Site 1705) | Oaxaca City , Mexico, 68020Radboudumc ( Site 1802) | Nijmegen Gelderland, Netherlands, 6525 GALeids Universitair Medisch Centrum-Medical Oncology ( Site 1801) | Leiden South Holland, Netherlands, 2333 ZAErasmus Medisch Centrum-Medical Oncology ( Site 1803) | Rotterdam South Holland, Netherlands, 3015 GDUniversitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804) | Utrecht , Netherlands, 3584 CXAuckland City Hospital ( Site 1901) | Auckland , New Zealand, 1023Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001) | Tromsø Troms, Norway, 9038Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit | Poznan Greater Poland Voivodeship, Poland, 61-848Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103) | Warsaw Masovian Voivodeship, Poland, 00-315Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit | Warsaw Masovian Voivodeship, Poland, 02-781Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106) | Bialystok Podlaskie Voivodeship, Poland, 15-027Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104) | Bialystok Podlaskie Voivodeship, Poland, 15-276Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi | Gdansk Pomeranian Voivodeship, Poland, 80-214Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21 | Gliwice Silesian Voivodeship, Poland, 44-101Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107) | Kielce Świętokrzyskie Voivodeship, Poland, 25-734Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk Chelyabinsk Oblast, Russia, 454087Ogarev Mordovia State University ( Site 2209) | Saransk Mordoviya, Respublika, Russia, 430005Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211) | Moscow Moscow, Russia, 115478Moscow City Oncology Hospital #62 ( Site 2214) | Krasnogorsk D-t Moscow Oblast, Russia, 143423SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216) | Yekaterinburg Sverdlovsk Oblast, Russia, 620905Seoul National University Hospital ( Site 2302) | Seoul , South Korea, 03080Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303) | Seoul , South Korea, 03722Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304) | Seoul , South Korea, 05505Gangnam Severance Hospital ( Site 2301) | Seoul , South Korea, 06273cukurova universty ( Site 2706) | Sarçam Adana, Turkey (Türkiye), 01250Istanbul Universitesi Cerrahpasa ( Site 2709) | Fatih Istanbul, Turkey (Türkiye), 34098Ege University Medicine of Faculty ( Site 2702) | Bornova İzmir, Turkey (Türkiye), 35100Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704) | Adana , Turkey (Türkiye), 01250Ankara University Hospital Cebeci ( Site 2701) | Ankara , Turkey (Türkiye), 06100Baskent Universitesi Ankara Hastanesi ( Site 2707) | Ankara , Turkey (Türkiye), 34180Bezmialem Vakf Üniversitesi-Oncology ( Site 2705) | Istanbul , Turkey (Türkiye), 34093T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma | Istanbul , Turkey (Türkiye), 34440Brighton and Sussex University Hospitals NHS Trust ( Site 2803) | East Sussex Brighton And Hove, United Kingdom, BN2 5BEAddenbrooke's Hospital ( Site 2808) | Cambridge Cambridgeshire, United Kingdom, CB2 2QQThe Royal Cornwall Hospital ( Site 2804) | Truro Cornwall, United Kingdom, TR1 3LJWestmorland General Hospital ( Site 2815) | Kendal Cumbria, United Kingdom, LA9 7RGNinewells Hospital and Medical School ( Site 2826) | Dundee Dundee City, United Kingdom, DD1 9SYLeicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812) | Leicester England, United Kingdom, Hammersmith Hospital-Medical Oncology ( Site 2818) | London London, City of, United Kingdom, W12 0HSVelindre Cancer Centre ( Site 2805) | Cardiff , United Kingdom, CF14 2TL
Investigators
Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full Text)
Documents provided by Merck Sharp & Dohme LLC: Study Protocol and Statistical Analysis Plan  January 30, 2024