A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

NCT06824467 | Recruiting Phase 3 DMC FDA Drug

• 8 other identifiers: 2870-022MK-2870-022TroFuse-0222023-508015-23-00U1111-1297-4489GOG-3103ENGOT-ov84jRCT2031240722
• Study Type: interventional
• Target: 770
• Locations: 27 countries
• Sites: 159

Brief Summary

The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Outcome Measures

Primary Outcomes (3)

• Part 1: Number of participants with one or more adverse events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 6 weeks

• Part 1: Number of participants who discontinue study intervention due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  Up to 6 weeks

• Part 2: Progression-free Survival (PFS)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.

  Up to approximately 4 years

Secondary Outcomes (7)

• Part 2: Overall Survival (OS)

  Up to approximately 4 years

• Part 2: Number of participants with one or more AEs

  Up to approximately 4 years

• Part 2: Number of participants who discontinue study intervention due to an AE

  Up to approximately 4 years

• Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score

  Baseline and up to approximately 4 years

• Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score

  Baseline and up to approximately 4 years

Study Arms (3)

Part 1: Sacituzumab tirumotecan + Bevacizumab

EXPERIMENTAL

Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks

Biological: Sacituzumab tirumotecan; Biological: Bevacizumab; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent)

Part 2: Sacituzumab tirumotecan

EXPERIMENTAL

Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Biological: Sacituzumab tirumotecan; Biological: Bevacizumab; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent)

Part 2: Standard of care (SOC)

ACTIVE COMPARATOR

Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.

Biological: Bevacizumab

Interventions

Dexamethasone (or equivalent) DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

Steroid mouthwash (dexamethasone or equivalent) DRUG

Rescue medication taken orally 2-4 times daily

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

Sacituzumab tirumotecan BIOLOGICAL

IV Infusion

Also known as: MK-2870, sac-TMT, SKB264

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

Bevacizumab BIOLOGICAL

IV Infusion

Also known as: Avastin, Altusan, MVASI

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan; Part 2: Standard of care (SOC)

H1 receptor antagonist DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

H2 receptor antagonist DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

Acetaminophen (or equivalent) DRUG

Rescue medication taken per approved product label before sacituzumab tirumotecan

Part 1: Sacituzumab tirumotecan + Bevacizumab; Part 2: Sacituzumab tirumotecan

Eligibility Criteria

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

You may qualify if:

• Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
• Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)
• Has platinum-sensitive epithelial OC
• Has provided tissue of a tumor lesion that was not previously irradiated
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
• Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
• Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

You may not qualify if:

• Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
• Has platinum-resistant OC or platinum-refractory OC
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
• Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received more than 2 prior lines of systemic therapy for OC
• Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
• Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
• Has an additional malignancy that is progressing or has required active treatment within the past 3 years
• Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active infection requiring systemic therapy
• Has active or ongoing stomatitis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• GOG Foundation: collaborator
• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator

Study Sites (159)

University of Alabama at Birmingham ( Site 0006)

Birmingham, Alabama, 35249, United States

RECRUITING

Alaska Women's Cancer Care ( Site 0096)

Anchorage, Alaska, 99508, United States

RECRUITING

Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001)

New Haven, Connecticut, 06510, United States

RECRUITING

Mount Sinai Cancer Center ( Site 0078)

Miami Beach, Florida, 33140, United States

RECRUITING

Sarasota Memorial Hospital ( Site 0075)

Sarasota, Florida, 34239, United States

RECRUITING

Florida Cancer Specialists East ( Site 7000)

West Palm Beach, Florida, 33401, United States

RECRUITING

Winship Cancer Institute of Emory University ( Site 0086)

Atlanta, Georgia, 30322, United States

RECRUITING

Augusta University - Georgia Cancer Center ( Site 0066)

Augusta, Georgia, 30912, United States

RECRUITING

Parkview Research Center at Parkview Regional Medical Center ( Site 0003)

Fort Wayne, Indiana, 46845, United States

RECRUITING

Women's Cancer Care ( Site 0067)

Covington, Louisiana, 70433, United States

RECRUITING

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0008)

Scarborough, Maine, 04074, United States

RECRUITING

St. Dominic's Hospital ( Site 0064)

Jackson, Mississippi, 39216, United States

ACTIVE NOT RECRUITING

Nebraska Methodist Hospital ( Site 0053)

Omaha, Nebraska, 68114, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0081)

Hackensack, New Jersey, 07601, United States

RECRUITING

Rutgers Cancer Institute of New Jersey ( Site 0071)

New Brunswick, New Jersey, 08901, United States

RECRUITING

University of New Mexico Comprehensive Cancer Center ( Site 0055)

Albuquerque, New Mexico, 87131, United States

RECRUITING

NYU Langone Hospital - Long Island ( Site 0015)

Mineola, New York, 11501, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center ( Site 0076)

New York, New York, 10016, United States

RECRUITING

FirstHealth Cancer Center ( Site 0079)

Pinehurst, North Carolina, 28374, United States

RECRUITING

University of Cincinnati Medical Center ( Site 0090)

Cincinnati, Ohio, 45219, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8010)

Eugene, Oregon, 97401, United States

RECRUITING

Women & Infants Hospital ( Site 0050)

Providence, Rhode Island, 02905, United States

RECRUITING

Henry-Joyce Cancer Clinic ( Site 0060)

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Oncology - Central/South Texas ( Site 8009)

Austin, Texas, 78758, United States

RECRUITING

Texas Oncology - DFW ( Site 8001)

Fort Worth, Texas, 76104, United States

RECRUITING

Texas Oncology - San Antonio ( Site 8005)

San Antonio, Texas, 78240, United States

RECRUITING

Texas Oncology - Gulf Coast ( Site 8003)

Webster, Texas, 77598, United States

RECRUITING

Virginia Cancer Specialists (VCS) ( Site 8011)

Fairfax, Virginia, 22031, United States

RECRUITING

Instituto Alexander Fleming ( Site 2909)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Fundación Respirar ( Site 2912)

Buenos Aires, Buenos Aires F.D., C1426AAL, Argentina

RECRUITING

Instituto de Oncologia de Rosario ( Site 2910)

Rosario, Santa Fe Province, S2000KZE, Argentina

RECRUITING

Hospital Aleman ( Site 2903)

CABA, C1118AAT, Argentina

RECRUITING

Hospital Italiano de Cordoba ( Site 2908)

Córdoba, X5004BAL, Argentina

RECRUITING

Blacktown Hospital ( Site 0211)

Sydney, New South Wales, 2148, Australia

RECRUITING

Gallipoli Medical Research Ltd ( Site 0214)

Brisbane, Queensland, 4120, Australia

RECRUITING

Epworth Freemasons ( Site 0217)

East Melbourne, Victoria, 3002, Australia

RECRUITING

Frankston Hospital ( Site 0216)

Frankston, Victoria, 3199, Australia

RECRUITING

Antwerp University Hospital ( Site 0304)

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0306)

Liège, Liege, 4000, Belgium

RECRUITING

AZ Sint-Lucas ( Site 0305)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

CHU UCL Namur/Site Sainte Elisabeth ( Site 0302)

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UZ Leuven ( Site 0301)

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Liga Norte Riograndense Contra o Cancer ( Site 0423)

Natal, Rio Grande do Norte, 59062-000, Brazil

RECRUITING

ANIMI - Unidade de Tratamento Oncologico ( Site 0419)

Lages, Santa Catarina, 88501-001, Brazil

RECRUITING

Hospital Paulistano ( Site 0421)

São Paulo, 01321-001, Brazil

RECRUITING

IBCC - Núcleo de Pesquisa e Ensino ( Site 0424)

São Paulo, 04014-002, Brazil

RECRUITING

Princess Margaret Cancer Centre ( Site 0518)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

McGill University Health Centre ( Site 0502)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Clinica Puerto Montt ( Site 0615)

Port Montt, Los Lagos Region, 5507642, Chile

RECRUITING

ONCOCENTRO APYS-ACEREY ( Site 0612)

Viña del Mar, Región de Valparaíso, 2520598, Chile

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Instituto Nacional De Cancerologia ( Site 0807)

Bogotá, Bogota D.C., 110411, Colombia

RECRUITING

Oncologos Del Occidente ( Site 0805)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fakultni nemocnice Ostrava ( Site 3323)

Ostrava-Poruba, Ostrava Mesto, 708 52, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze ( Site 3325)

Prague, 128 08, Czechia

RECRUITING

Fakultni nemocnice v Motole ( Site 3322)

Prague, 150 06, Czechia

RECRUITING

Rigshospitalet ( Site 0904)

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Herlev Hospital ( Site 0903)

Herlev, Capital Region, 2730, Denmark

RECRUITING

Aalborg Universitetshospital ( Site 0901)

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Vejle Sygehus ( Site 0902)

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Oulun yliopistollinen sairaala ( Site 1003)

Oulu, North Ostrobothnia, 90220, Finland

RECRUITING

Kuopion Yliopistollinen Sairaala ( Site 1004)

Kuopio, Northern Savonia, 70200, Finland

RECRUITING

Tampereen yliopistollinen sairaala ( Site 1002)

Tampere, Pirkanmaa, 33520, Finland

RECRUITING

Centre Oscar Lambret ( Site 1104)

Lille, Ain, 59020, France

RECRUITING

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 1101)

Bordeaux, Aquitaine, 33076, France

RECRUITING

Centre Hopitalier Lyon Sud ( Site 1110)

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

RECRUITING

Centre Francois Baclesse ( Site 1108)

Caen, Calvados, 14076, France

RECRUITING

Hôpital Privé Des Côtes d'Armor ( Site 1106)

Plérin, Cotes-d Armor, 22190, France

RECRUITING

Oncopole Claudius Regaud ( Site 1109)

Toulouse, Haute-Garonne, 31059, France

RECRUITING

Pôle Santé Léonard de Vinci ( Site 1112)

Chambray-lès-Tours, Indre-et-Loire, 37170, France

RECRUITING

Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1111)

Paris, Paris, 75014, France

RECRUITING

Institut De Cancerologie De L Ouest ( Site 1107)

Saint-Herblain, Pays de la Loire Region, 44805, France

RECRUITING

Sainte Catherine Institut du Cancer Avignon Provence ( Site 1105)

Avignon, Vaucluse, 84918, France

RECRUITING

Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 1102)

Paris, 75020, France

RECRUITING

Aretaieio Hospital ( Site 0701)

Athens, Attica, 115 28, Greece

RECRUITING

Bacs-Kiskun Megyei Korhaz ( Site 3920)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3924)

Szeged, Csongrád megye, 6720, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont ( Site 3922)

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Hillel Yaffe Medical Center ( Site 1404)

Hadera, 3810101, Israel

RECRUITING

Rambam Health Care Campus ( Site 1402)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 1405)

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center. ( Site 1403)

Kfar Saba, 4428164, Israel

RECRUITING

Sheba Medical Center ( Site 1401)

Ramat Gan, 5265601, Israel

RECRUITING

CRO-IRCCS ( Site 1510)

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1507)

Milan, Milano, 20133, Italy

RECRUITING

Azienda Ospedaliero Universitaria Pisana ( Site 1504)

Pisa, Tuscany, 56126, Italy

RECRUITING

Instituto Tumori Giovanni Paolo II ( Site 1505)

Bari, 70124, Italy

RECRUITING

Istituto Europeo di Oncologia ( Site 1506)

Milan, 20141, Italy

RECRUITING

Humanitas San Pio X Hospital ( Site 1503)

Milan, 20159, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1501)

Naples, 80131, Italy

RECRUITING

Istituto Oncologico Veneto IRCCS ( Site 1508)

Padova, 35128, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli ( Site 1502)

Roma, 00168, Italy

RECRUITING

Ospedale Mauriziano ( Site 1509)

Torino, 10128, Italy

RECRUITING

Aichi Cancer Center ( Site 1626)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center ( Site 1631)

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Ehime University Hospital ( Site 1637)

Tōon, Ehime, 791-0295, Japan

RECRUITING

Kurume University Hospital ( Site 1640)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Gunma Prefectural Cancer Center ( Site 1630)

Ōta, Gunma, 373-8550, Japan

RECRUITING

Hokkaido University Hospital ( Site 1634)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Iwate Medical University Hospital ( Site 1635)

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

Saitama Medical University International Medical Center ( Site 1632)

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 1639)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Keio University Hospital ( Site 1636)

Shinjyuku, Tokyo, 160-8582, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 1628)

Fukuoka, 811-1395, Japan

RECRUITING

Kagoshima City Hospital ( Site 1638)

Kagoshima, 890-8760, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 1633)

Niigata, 951-8566, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1629)

Osaka, 541-8567, Japan

RECRUITING

CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)

Guadalajara, Jalisco, 44630, Mexico

RECRUITING

Higiea Oncologia ( Site 1713)

Mexico City, Mexico City, 11819, Mexico

RECRUITING

Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1711)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 1716)

Monterrey, Nuevo León, 64710, Mexico

RECRUITING

Servicios de Oncología Médica Integral - Monterrey ( Site 1712)

Monterrey, Nuevo León, 66220, Mexico

RECRUITING

Centro de Investigación Oncológica Galerías SC ( Site 1720)

Aguascalientes, 20124, Mexico

RECRUITING

Cryptex Investigación Clínica S.A. de C.V. ( Site 1715)

Cuauhtémoc, 6100, Mexico

RECRUITING

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 1717)

Mexico City, 04700, Mexico

RECRUITING

Centro de Investigacion Clinica de Oaxaca ( Site 1714)

Oaxaca City, 68020, Mexico

RECRUITING

Hospital Guillermo Almenara Irigoyen ( Site 3608)

Lima, 15001, Peru

RECRUITING

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3604)

Lima, 15036, Peru

RECRUITING

INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 3601)

Lima, 15038, Peru

RECRUITING

Clínica San Felipe ( Site 3603)

Lima, 15072, Peru

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)

Poznan, Greater Poland Voivodeship, 61-848, Poland

RECRUITING

Bialostockie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

RECRUITING

Swietokrzyskie Centrum Onkologii. ( Site 2105)

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

Hospital da Luz ( Site 3802)

Lisbon, 1500-650, Portugal

RECRUITING

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 3801)

Porto, 4200-072, Portugal

RECRUITING

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2211)

Craiova, Dolj, 200746, Romania

RECRUITING

Cabinet Medical Oncomed ( Site 2217)

Timișoara, Timiș County, 300239, Romania

RECRUITING

Spitalul Clinic Filantropia ( Site 2213)

Bucharest, 011132, Romania

RECRUITING

National Cancer Center ( Site 2305)

Goyang-si, Kyonggi-do, 10408, South Korea

RECRUITING

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, 03722, South Korea

RECRUITING

Asan Medical Center ( Site 2304)

Songpa-gu, Seoul, 05505, South Korea

RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center ( Site 2303)

Seoul, 06351, South Korea

RECRUITING

Institut Català d'Oncologia (ICO) - Girona ( Site 2402)

Girona, Gerona, 17007, Spain

RECRUITING

Hospital General Gregorio Maranon de Madrid ( Site 2412)

Madrid, Madrid, Comunidad de, 28007, Spain

RECRUITING

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de, 28027, Spain

RECRUITING

Hosp Clinico Universitario de Valencia ( Site 2401)

Valencia, Valenciana, Comunitat, 46010, Spain

RECRUITING

Hospital Vall D Hebron ( Site 2403)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic I Provincial de Barcelona ( Site 2409)

Barcelona, 08036, Spain

RECRUITING

ICO L Hospitalet ( Site 2408)

Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Reina Sofia ( Site 2406)

Córdoba, 14004, Spain

RECRUITING

Hospital Ramon y Cajal ( Site 2405)

Madrid, 28034, Spain

RECRUITING

Hospital Clinico San Carlos... ( Site 2410)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre ( Site 2411)

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz ( Site 2404)

Madrid, 28046, Spain

RECRUITING

Taichung Veterans General Hospital ( Site 2603)

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2602)

Tainan, 704302, Taiwan

RECRUITING

National Taiwan University Hospital ( Site 2601)

Taipei, 10002, Taiwan

RECRUITING

Mackay Memorial Hospital ( Site 2604)

Taipei, 104, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch ( Site 2605)

Taoyuan District, 333, Taiwan

RECRUITING

Ramathibodi Hospital ( Site 3402)

Bangkok, Bangkok, 10400, Thailand

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 3401)

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Western General Hospital ( Site 2806)

Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom

RECRUITING

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)

London, London, City of, SW3 6JJ, United Kingdom

RECRUITING

Royal Marsden Hospital (Sutton) ( Site 2802)

Sutton, London, City of, SM2 5PT, United Kingdom

RECRUITING

Leicester Royal Infirmary ( Site 2808)

Leicester, LE1 5WW, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab; Histamine Antagonists; Histamine H2 Antagonists; Acetaminophen; Dexamethasone

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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): April 27, 2029
• Study Completion (Estimated): November 9, 2032
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CL (2); ME (9); TH (2); HU (3); AR (6); AU (4); BE (5); CA (2); IT (10); RO (4); KR (5); FR (11); GB (4); CO (3); PL (3); CZ (3); PT (2); US (29); JP (14); GR (1); DK (4); FI (3); BR (4); IL (5); TW (5); PE (4); ES (12)