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

NCT05116189 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 8 other identifiers: 3475-B96MK-3475-B96KEYNOTE-B96ENGOT-ov65jRCT20512101842023-506177-35-00U1111-1287-53182020-005027-37
• Study Type: interventional
• Target: 643
• Locations: 25 countries
• Sites: 187

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.

Conditions

Fallopian Tube Neoplasms; Ovarian Cancer; Carcinoma, Ovarian Epithelial

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to ~38 months

• 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.

  Up to ~38 months

Secondary Outcomes (9)

• PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1

  Up to ~38 months

• PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants

  Up to ~38 months

• Overall Survival (OS)

  Up to ~64 months

• Number of Participants Who Experience an Adverse Event (AE)

  Up to ~64 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to ~64 months

Study Arms (2)

Pembrolizumab + paclitaxel ± bevacizumab

EXPERIMENTAL

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; Drug: Paclitaxel; Drug: Bevacizumab; Drug: Docetaxel

Placebo + paclitaxel ± bevacizumab

PLACEBO COMPARATOR

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; Drug: Bevacizumab; Other: Placebo for pembrolizumab; Drug: Docetaxel

Interventions

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475,, KEYTRUDA®

Pembrolizumab + paclitaxel ± bevacizumab

Paclitaxel DRUG

IV infusion

Pembrolizumab + paclitaxel ± bevacizumab; Placebo + paclitaxel ± bevacizumab

Bevacizumab DRUG

IV infusion

Also known as: AVASTIN®, Zirabev

Pembrolizumab + paclitaxel ± bevacizumab; Placebo + paclitaxel ± bevacizumab

Placebo for pembrolizumab OTHER

IV infusion

Also known as: normal saline or dextrose

Placebo + paclitaxel ± bevacizumab

Docetaxel DRUG

IV infusion

Also known as: TAXOTERE®

Pembrolizumab + paclitaxel ± bevacizumab; Placebo + paclitaxel ± bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (187)

HonorHealth ( Site 0041)

Phoenix, Arizona, 85016, United States

Location

Marin Cancer Care ( Site 0055)

Greenbrae, California, 94904, United States

Location

Pacific Cancer Care ( Site 0028)

Monterey, California, 93940, United States

Location

Eisenhower Medical Center ( Site 0067)

Rancho Mirage, California, 92270, United States

Location

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0004)

New Haven, Connecticut, 06511, United States

Location

University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 0054

Gainesville, Florida, 32610, United States

Location

Sarasota Memorial Hospital ( Site 0018)

Sarasota, Florida, 34239, United States

Location

Moffitt Cancer Center ( Site 0033)

Tampa, Florida, 33612, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0005)

Marietta, Georgia, 30060, United States

Location

Advocate Medical Group-Oncology ( Site 0049)

Park Ridge, Illinois, 60068, United States

Location

Parkview Research Center at Parkview Regional Medical Center ( Site 0027)

Fort Wayne, Indiana, 46845, United States

Location

St. Vincent Hospital and Health Care Center, Inc ( Site 0032)

Indianapolis, Indiana, 46260, United States

Location

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0040)

Edgewood, Kentucky, 41017, United States

Location

WK Physicians Network / Hematology Oncology Associates ( Site 0034)

Shreveport, Louisiana, 71103, United States

Location

Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0015)

Baltimore, Maryland, 21202, United States

Location

University of Massachusetts Chan Medical School-Division of Gynecologic Oncology ( Site 0003)

Worcester, Massachusetts, 01605, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0007)

Hackensack, New Jersey, 07601, United States

Location

Roswell Park Cancer Institute ( Site 0039)

Buffalo, New York, 14263, United States

Location

Columbia University Medical Center ( Site 0010)

New York, New York, 10032, United States

Location

Novant Health Presbyterian Medical Center ( Site 0029)

Charlotte, North Carolina, 28204, United States

Location

Duke Cancer Institute ( Site 0038)

Durham, North Carolina, 27710, United States

Location

Novant Health Forsyth Medical Center ( Site 0057)

Winston-Salem, North Carolina, 27103, United States

Location

Aultman Hospital-Oncology Clinical Trials ( Site 0009)

Canton, Ohio, 44710, United States

Location

MetroHealth Medical Center-Cancer Care Center ( Site 0047)

Cleveland, Ohio, 44109, United States

Location

Providence Portland Medical Center ( Site 0048)

Portland, Oregon, 97213, United States

Location

University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0024)

Pittsburgh, Pennsylvania, 15219, United States

Location

Sanford Cancer Center ( Site 0064)

Sioux Falls, South Dakota, 57104, United States

Location

The West Clinic, PLLC dba West Cancer Center ( Site 0058)

Germantown, Tennessee, 38138, United States

Location

Texas Oncology - Dallas (Presbyterian) ( Site 0065)

Dallas, Texas, 75231, United States

Location

Texas Oncology - The Woodlands_Lee ( Site 0043)

The Woodlands, Texas, 77380, United States

Location

Inova Schar Cancer Institute ( Site 0019)

Fairfax, Virginia, 22031, United States

Location

Westmead Hospital-Department of Gynaecological Oncology ( Site 0201)

Westmead, New South Wales, 2145, Australia

Location

Gallipoli Medical Research Foundation-GMRF CTU ( Site 0202)

Brisbane, Queensland, 4120, Australia

Location

Epworth Freemasons ( Site 0204)

Melbourne, Victoria, 3002, Australia

Location

St. John of God Subiaco Hospital ( Site 0203)

Subiaco, Western Australia, 6008, Australia

Location

Institut Jules Bordet-Medicine Oncology ( Site 0302)

Brussels, Bruxelles-Capitale, Region de, 1000, Belgium

Location

UZ Gent-Medical oncology ( Site 0301)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven ( Site 0303)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Groeninge Campus Kennedylaan-Oncology ( Site 0305)

Kortrijk, West-Vlaanderen, 8500, Belgium

Location

Hospital Araújo Jorge ( Site 0401)

Goiânia, Goiás, 74605-070, Brazil

Location

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0404)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

ANIMI - Unidade de Tratamento Oncologico ( Site 0408)

Lages, Santa Catarina, 88501001, Brazil

Location

BP - A Beneficencia Portuguesa de São Paulo ( Site 0403)

São Paulo, São Paulo, 01323-001, Brazil

Location

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0405)

São Paulo, São Paulo, 04014-002, Brazil

Location

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0402)

Rio de Janeiro, 20220-410, Brazil

Location

Tom Baker Cancer Center ( Site 0511)

Calgary, Alberta, T2N 4N2, Canada

Location

BC Cancer Abbotsford ( Site 0512)

Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

Location

BC Cancer Victoria ( Site 0513)

Victoria, British Columbia, V8R 6V5, Canada

Location

Kingston Health Sciences Centre-Kingston General Hospital Si-Oncology and/or Hematology - Gynecolog

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0508)

Toronto, Ontario, M4N 3M5, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0501)

Montreal, Quebec, H1T 2M4, Canada

Location

Jewish General Hospital ( Site 0505)

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre ( Site 0502)

Montreal, Quebec, H4A 3J1, Canada

Location

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, G1J 1Z4, Canada

Location

Saskatoon Cancer Center ( Site 0510)

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Clínica Puerto Montt ( Site 0601)

Port Montt, Los Lagos Region, 5500243, Chile

Location

Oncovida ( Site 0603)

Santiago, Region M. de Santiago, 7510032, Chile

Location

Instituto de Radiomedicina-hemato-oncologia ( Site 0604)

Santiago, Region M. de Santiago, 7630370, Chile

Location

Clínica Vespucio-Hemato - Ocology ( Site 0607)

Santiago, Region M. de Santiago, 8241479, Chile

Location

Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0609)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Bradfordhill ( Site 0605)

Santiago, Region M. de Santiago, 8420383, Chile

Location

James Lind Centro de Investigación del Cáncer ( Site 0602)

Temuco, Región de la Araucanía, 4780000, Chile

Location

CIDO SpA-Oncology ( Site 0608)

Temuco, Región de la Araucanía, 4810148, Chile

Location

Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 0709)

Hefei, Anhui, 230001, China

Location

Beijing Cancer hospital ( Site 0711)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Peking Union Medical College Hospital-Gynecological center of tumor ( Site 0702)

Beijing, Beijing Municipality, 100730, China

Location

Fujian Provincial Cancer Hospital ( Site 0713)

Fuzhou, Fujian, 350014, China

Location

Lanzhou university second hospital ( Site 0734)

Lanzhou, Gansu, 730030, China

Location

Zhujiang Hospital ( Site 0739)

Guangzhou, Guangdong, 510280, China

Location

Affiliated Hospital of Guangdong Medical University ( Site 0743)

Zhanjiang, Guangdong, 524004, China

Location

Guangxi Medical University Affiliated Tumor Hospital ( Site 0717)

Nanning, Guangxi, 530021, China

Location

Hainan General Hospital ( Site 0736)

Haikou, Hainan, 570311, China

Location

Henan Cancer Hospital ( Site 0718)

Zhengzhou, Henan, 450008, China

Location

Wuhan Union Hospital-Medical Oncology ( Site 0735)

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital-Hubei Cancer Hospital ( Site 0708)

Wuhan, Hubei, 430079, China

Location

Xiangya Hospital Central South University-Gynecology ( Site 0705)

Changsha, Hunan, 410008, China

Location

Hunan Cancer Hospital ( Site 0704)

Changsha, Hunan, 410013, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology (

Nanjing, Jiangsu, 210000, China

Location

Zhongda Hospital Southeast University ( Site 0723)

Nanjing, Jiangsu, China

Location

Jiangxi Maternal and Child Health Hospital-Oncology Department ( Site 0716)

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University ( Site 0710)

Changchun, Jilin, 130021, China

Location

Shandong Cancer Hospital-Oncology Department ( Site 0733)

Jinan, Shandong, 250117, China

Location

LinYi Cancer Hospital ( Site 0731)

Linyi, Shandong, 276001, China

Location

Obstetrics & Gynecology Hospital of Fudan University ( Site 0715)

Shanghai, Shanghai Municipality, 200011, China

Location

Fudan University Shanghai Cancer Center-Gynecologic Oncology Department ( Site 0701)

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 0744)

Shanghai, Shanghai Municipality, 201204, China

Location

West China Second University Hospital Sichuan University ( Site 0740)

Chengdu, Sichuan, 610066, China

Location

Tianjin Central Hosptial of Gynecology Obstetrics ( Site 0737)

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute and Hospital ( Site 0720)

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Province Cancer Hospital-Gynecology Department ( Site 0714)

Kunming, Yunnan, 650106, China

Location

The Affiliated Women's Hospital of Zhejiang University-Obstetrics and Gynecology ( Site 0741)

Hangzhou, Zhejiang, 3100000, China

Location

The First Affiliated Hospital of Wenzhou Medical University-Gynecology ( Site 0706)

Wenzhou, Zhejiang, 325000, China

Location

Fundación Colombiana de Cancerología Clínica Vida ( Site 0808)

Medellín, Antioquia, 050030, Colombia

Location

Clinica de la Costa LTDA-Clinical Research Oncology & Hematology -Pediatric ( Site 0809)

Barranquilla, Atlántico, 080020, Colombia

Location

Clínica Universitaria Colombia ( Site 0806)

Bogotá, Bogota D.C., 111221, Colombia

Location

Oncologos del Occidente ( Site 0807)

Pereira, Risaralda Department, 660001, Colombia

Location

Hemato Oncologos SA ( Site 0801)

Cali, Valle del Cauca Department, 76001, Colombia

Location

Aalborg Universitetshospital, Syd ( Site 0901)

Aalborg, North Denmark, 9000, Denmark

Location

Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001)

Turku, Southwest Finland, 20521, Finland

Location

Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi

Brest, Brittany Region, 29200, France

Location

Centre François Baclesse-Recherche clinique ( Site 2904)

Caen, Calvados, 14076, France

Location

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-oncologie ( Site 2907)

Limoges, Haute-Vienne, 87042, France

Location

Institut Curie - site Saint-Cloud ( Site 2909)

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 2901)

Rennes, Ille-et-Vilaine, 35042, France

Location

Centre de Cancérologie du Grand Montpellier ( Site 2908)

Montpellier, Languedoc-Roussillon, 34070, France

Location

Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 2905)

Nantes, Loire-Atlantique, 44277, France

Location

Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1205)

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Bonn-Gynaecological oncology ( Site 1203)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Zentrum fuer ambulante gynaekologische Onkologie (ZAGO) ( Site 1207)

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

CaritasKlinikum Saarbrücken St. Theresia ( Site 1211)

Saarbrücken, Saarland, 66113, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig-Department of Gynecology and Obstetrics ( Site 1213)

Leipzig, Saxony, 04103, Germany

Location

Charité Campus Virchow-Klinikum ( Site 1201)

Berlin, 13353, Germany

Location

Asklepios Kliniken Hamburg-Asklepios Klinik Barmbek ( Site 1214)

Hamburg, 22307, Germany

Location

St. James's Hospital-Cancer clinical trials office ( Site 2821)

Dublin, D08 E9P6, Ireland

Location

Emek Medical Center-Gyn-Onc ( Site 1406)

Afula, 1834111, Israel

Location

Soroka Medical Center ( Site 1404)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Gyneco-oncology unit ( Site 1402)

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center ( Site 1405)

Jerusalem, 9103102, Israel

Location

Rabin Medical Center ( Site 1401)

Petah Tikva, 49100, Israel

Location

Sheba Medical Center ( Site 1407)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 1403)

Tel Aviv, 6423906, Israel

Location

IRCCS - AOU di Bologna-SSD Oncologia medica Addarii ( Site 1501)

Bologna, Emilia-Romagna, 40138, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1503)

Milan, Lombardy, 20133, Italy

Location

Ospedale San Gerardo-ASST Monza-Oncologia ( Site 1508)

Monza, Lombardy, 20900, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda ( Site 1505)

Milan, Milano, 20162, Italy

Location

Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 1507)

Turin, Piedmont, 10128, Italy

Location

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1504)

Brescia, 25123, Italy

Location

Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 1502)

Milan, 20141, Italy

Location

Aichi Cancer Center Hospital ( Site 1610)

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East ( Site 1609)

Kashiwa, Chiba, 277-8577, Japan

Location

National Hospital Organization Shikoku Cancer Center ( Site 1603)

Matsuyama, Ehime, 791-0280, Japan

Location

Ehime University Hospital ( Site 1606)

Tōon, Ehime, 791-0295, Japan

Location

Kurume University Hospital ( Site 1607)

Kurume, Fukuoka, 830-0011, Japan

Location

Hokkaido University Hospital ( Site 1604)

Sapporo, Hokkaido, 060-8648, Japan

Location

Iwate Medical University Hospital ( Site 1613)

Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan

Location

Nippon Medical School Musashi Kosugi Hospital ( Site 1614)

Kawasaki, Kanagawa, 211-8533, Japan

Location

Saitama Medical University International Medical Center ( Site 1601)

Hidaka-shi, Saitama, 350-1200, Japan

Location

Shizuoka Cancer Center ( Site 1611)

Nakatogari, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital ( Site 1612)

Chuo-ku, Tokyo, 104-0045, Japan

Location

Japanese Foundation for Cancer Research ( Site 1605)

Koto, Tokyo, 135-8550, Japan

Location

Osaka International Cancer Institute ( Site 1602)

Osaka, 541-8567, Japan

Location

Investigación Oncofarmacéutica-Investigación clínica ( Site 1706)

La Paz, Baja California Sur, 23040, Mexico

Location

COI Centro Oncologico Internacional S.A.P.I. de C.V.-Investigation Unit COI ( Site 1703)

Mexico City, Mexico City, 04700, Mexico

Location

INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1701)

Mexico City, Mexico City, 14070, Mexico

Location

iCan Oncology Center Centro Medico AVE ( Site 1704)

Monterrey, Nuevo León, 64710, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 1705)

Oaxaca City, 68020, Mexico

Location

Radboudumc ( Site 1802)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Leids Universitair Medisch Centrum-Medical Oncology ( Site 1801)

Leiden, South Holland, 2333 ZA, Netherlands

Location

Erasmus Medisch Centrum-Medical Oncology ( Site 1803)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1804)

Utrecht, 3584 CX, Netherlands

Location

Auckland City Hospital ( Site 1901)

Auckland, 1023, New Zealand

Location

Universitetssykehuset Nord-Norge HF-Kreftavdelingen ( Site 2001)

Tromsø, Troms, 9038, Norway

Location

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Me-Oddzial Ginekologii Onkologicznej ( Sit

Poznan, Greater Poland Voivodeship, 61-848, Poland

Location

Szpital Kliniczny im. Księżnej Anny Mazowieckiej ( Site 2103)

Warsaw, Masovian Voivodeship, 00-315, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Gynecological Oncology Department ( Sit

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 2106)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku-Uniwersyteckie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 21

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2107)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

Location

Chelyabinsk Regional Clinical Oncology Dispensary-Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, Chelyabinsk Oblast, 454087, Russia

Location

Ogarev Mordovia State University ( Site 2209)

Saransk, Mordoviya, Respublika, 430005, Russia

Location

Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF-Chemotherapy #2 ( Site 2211)

Moscow, Moscow, 115478, Russia

Location

Moscow City Oncology Hospital #62 ( Site 2214)

Krasnogorsk D-t, Moscow Oblast, 143423, Russia

Location

SVERDLOVSK REGIONAL ONCOLOGY DISPENSARY-Oncogynecology Department ( Site 2216)

Yekaterinburg, Sverdlovsk Oblast, 620905, Russia

Location

Seoul National University Hospital ( Site 2302)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 2303)

Seoul, 03722, South Korea

Location

Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 2304)

Seoul, 05505, South Korea

Location

Gangnam Severance Hospital ( Site 2301)

Seoul, 06273, South Korea

Location

cukurova universty ( Site 2706)

Sarçam, Adana, 01250, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa ( Site 2709)

Fatih, Istanbul, 34098, Turkey (Türkiye)

Location

Ege University Medicine of Faculty ( Site 2702)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 2704)

Adana, 01250, Turkey (Türkiye)

Location

Ankara University Hospital Cebeci ( Site 2701)

Ankara, 06100, Turkey (Türkiye)

Location

Baskent Universitesi Ankara Hastanesi ( Site 2707)

Ankara, 34180, Turkey (Türkiye)

Location

Bezmialem Vakf Üniversitesi-Oncology ( Site 2705)

Istanbul, 34093, Turkey (Türkiye)

Location

T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma

Istanbul, 34440, Turkey (Türkiye)

Location

Brighton and Sussex University Hospitals NHS Trust ( Site 2803)

East Sussex, Brighton And Hove, BN2 5BE, United Kingdom

Location

Addenbrooke's Hospital ( Site 2808)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

The Royal Cornwall Hospital ( Site 2804)

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Westmorland General Hospital ( Site 2815)

Kendal, Cumbria, LA9 7RG, United Kingdom

Location

Ninewells Hospital and Medical School ( Site 2826)

Dundee, Dundee City, DD1 9SY, United Kingdom

Location

Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 2812)

Leicester, England, United Kingdom

Location

Hammersmith Hospital-Medical Oncology ( Site 2818)

London, London, City of, W12 0HS, United Kingdom

Location

Velindre Cancer Centre ( Site 2805)

Cardiff, CF14 2TL, United Kingdom

Location

Related Publications (1)

• Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

  PMID: 37185961 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Paclitaxel; Bevacizumab; Saline Solution; Glucose; Docetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 10, 2021
• Study Start: December 13, 2021
• Primary Completion: March 5, 2025
• Study Completion (Estimated): July 16, 2027
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CO (5); KR (4); TU (8); FR (7); ME (5); NL (4); DE (9); RU (5); JP (13); DK (1); CA (10); IL (7); BE (4); BR (6); CL (8); FI (1); IT (7); NZ (1); GB (8); US (31); PL (8); AU (4); NO (1); CN (29); IE (1)