A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

NCT07318558 | Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: 2870-021MK-2870-021GOG-3102ENGOT-ov85U1111-1297-51582023-508047-40-00jRCT2031250647
• Study Type: interventional
• Target: 900
• Locations: 27 countries
• Sites: 133

Brief Summary

Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:

• Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.
• Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.

Conditions

Ovarian Neoplasms; Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) 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 have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

  Up to approximately 49 months

Secondary Outcomes (8)

• Overall Survival (OS)

  Up to approximately 78 months

• Progression-Free Survival 2 (PFS2)

  Up to approximately 78 months

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

  Up to approximately 78 months

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

  Up to approximately 78 months

• Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

  Baseline and up to approximately 78 months

Study Arms (2)

Sac-TMT +/- Bevacizumab

EXPERIMENTAL

Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses.

Drug: Sacituzumab tirumotecan; Drug: Bevacizumab; Drug: Rescue Medications

Standard of Care

ACTIVE COMPARATOR

Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab.

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Administered via IV infusion at a dose of 15mg/kg

Also known as: Avastin, Altuzan, MVASI

Sac-TMT +/- Bevacizumab; Standard of Care

Sacituzumab tirumotecan DRUG

Administered via intravenous (IV) infusion at a dose of 4mg/kg

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

Sac-TMT +/- Bevacizumab

Rescue Medications DRUG

Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.

Sac-TMT +/- Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\>50%) Grade 3 features are present.
• Has completed primary debulking surgery or interval debulking surgery.
• Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
• Has provided tumor tissue that is not previously irradiated.
• Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV
• Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
• Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.

You may not qualify if:

• Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has a history of severe eye disease.
• Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.
• Had a live or live-attenuated vaccine within 30 days of randomization.
• Has a known additional malignancy that is progressing or required active treatment within the past 3 years.
• Has active infection requiring systemic therapy.
• Has concurrent and active HBV and HCV infections.
• Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.
• Has not recovered from major surgery or has ongoing surgical complications.
• Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.
• Active or ongoing stomatitis of any grade.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (135)

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida, 33140, United States

RECRUITING

Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)

Orlando, Florida, 32806, United States

RECRUITING

Winship Cancer Institute of Emory University ( Site 0037)

Atlanta, Georgia, 30308, United States

RECRUITING

Illinois Cancer Specialists (ICS) ( Site 8009)

Arlington Heights, Illinois, 60005, United States

RECRUITING

Parkview Research Center at Parkview Regional Medical Center ( Site 0055)

Fort Wayne, Indiana, 46845, United States

RECRUITING

Women's Cancer Care ( Site 0018)

Covington, Louisiana, 70433, United States

RECRUITING

Maine Medical Center Research Institute-MaineHealth/Maine Medical Partners - GynOnc ( Site 0060)

Scarborough, Maine, 04074, United States

RECRUITING

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska, 68114, United States

RECRUITING

University Of Nebraska Medical Center ( Site 0035)

Omaha, Nebraska, 68198, United States

RECRUITING

University of Cincinnati Medical Center ( Site 0042)

Cincinnati, Ohio, 45219, United States

RECRUITING

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

Tulsa, Oklahoma, 74146, United States

RECRUITING

Women & Infants Hospital ( Site 0001)

Providence, Rhode Island, 02905, United States

RECRUITING

West Cancer Center and Research Institute ( Site 0013)

Germantown, Tennessee, 38138, United States

RECRUITING

University of Tennessee Medical Center ( Site 0087)

Knoxville, Tennessee, 37920, United States

RECRUITING

Hospital Aleman ( Site 2903)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1119ACN, Argentina

RECRUITING

Instituto Alexander Fleming ( Site 2902)

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

Sanatorio Parque - Oncología ( Site 2911)

Rosario, Santa Fe Province, S2000DVC, Argentina

RECRUITING

Instituto de Oncologia de Rosario ( Site 2909)

Rosario, Santa Fe Province, S2000KZE, Argentina

RECRUITING

Hospital Britanico de Buenos Aires ( Site 2905)

CABA, C1280AEB, Argentina

RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 2907)

La Rioja, F5300COE, Argentina

RECRUITING

Gallipoli Medical Research Ltd ( Site 0204)

Brisbane, Queensland, 4120, Australia

RECRUITING

Epworth Freemasons ( Site 0207)

East Melbourne, Victoria, 3002, Australia

RECRUITING

Medizinische Universitat Wien ( Site 0102)

Vienna, State of Vienna, 1090, Austria

RECRUITING

Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0101)

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Grand Hopital de Charleroi ( Site 0303)

Charleroi, Hainaut, 6000, Belgium

RECRUITING

AZ Maria Middelares ( 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 0417)

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

RECRUITING

Hospital São Lucas da PUCRS ( Site 0415)

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

RECRUITING

ANIMI - Unidade de Tratamento Oncologico ( Site 0421)

Lages, Santa Catarina, 88501-001, Brazil

RECRUITING

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0414)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

CIUSSS - Saguenay-Lac-Saint-Jean ( Site 0519)

Chicoutimi, Quebec, G7H 5H6, Canada

RECRUITING

McGill University Health Centre ( Site 0516)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Clinica Puerto Montt ( Site 0606)

Port Montt, Los Lagos Region, 5507642, Chile

RECRUITING

FALP ( Site 0607)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 0602)

Santiago, Region M. de Santiago, 8330073, Chile

RECRUITING

ONCOCENTRO APYS-ACEREY ( Site 0603)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Fundacion Colombiana de Cancerología Clinica Vida ( Site 0803)

Medellín, Antioquia, 050030, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0801)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0802)

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

Instituto Nacional De Cancerologia ( Site 0808)

Bogota, Cundinamarca, 111151, Colombia

RECRUITING

Oncólogos del Occidente S.A.S. ( Site 0806)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fakultni Nemocnice Brno Bohunice ( Site 3304)

Brno, Brno-mesto, 602 00, Czechia

RECRUITING

Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 3303)

Ostrava-Poruba, Ostrava Mesto, 708 52, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove ( Site 3307)

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady ( Site 3306)

Prague, 100 34, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze ( Site 3305)

Prague, 128 08, Czechia

RECRUITING

Fakultni nemocnice motol ( Site 3302)

Prague, 150 06, Czechia

RECRUITING

Herlev Hospital ( Site 0902)

Herlev, Capital Region, 2730, Denmark

RECRUITING

Aalborg Universitetshospital ( Site 0901)

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Aarhus Universitetshospital, Skejby ( Site 0903)

Aarhus, North Denmark, 8200, Denmark

RECRUITING

Odense Universitets Hospital ( Site 0904)

Odense, Region Syddanmark, 9000, 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

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

Turku, Southwest Finland, 20520, Finland

RECRUITING

CENTRE LEON BERARD ( Site 1101)

Lyon, Auvergne-Rhône-Alpes, 69008, France

RECRUITING

Hopitaux Universitaires de Strasbourg ( Site 1109)

Strasbourg, Bas-Rhin, 67000, France

RECRUITING

Hôpital Privé Des Côtes d'Armor ( Site 1102)

Plérin, Cotes-d Armor, 22190, France

RECRUITING

CHRU de Brest - Hopital de la Cavale Blanche ( Site 1104)

Brest, Finistere, 29200, France

RECRUITING

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 1105)

Tours, Indre-et-Loire, 37044, France

RECRUITING

Centre Oscar Lambret ( Site 1106)

Lille, Nord, 59020, France

RECRUITING

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1113)

Clermont-Ferrand, Puy-de-Dome, 63003, France

RECRUITING

Alexandra General Hospital of Athens ( Site 0703)

Athens, Attica, 115 28, Greece

RECRUITING

Aretaieio Hospital ( Site 0701)

Athens, Attica, 115 28, Greece

RECRUITING

Agios Loukas Clinic ( Site 0702)

Thessaloniki, 552 36, Greece

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 3910)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 3911)

Győr, Győr-Moson-Sopron, 9024, Hungary

RECRUITING

Országos Onkológiai Intézet-Ngyógyászat ( Site 3913)

Budapest, 1122, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont-Szülészeti és Nőgyógyászati Klinika ( Site 3912)

Debrecen, 4032, Hungary

RECRUITING

St James Hospital ( Site 1302)

Dublin, D08 E9P6, Ireland

RECRUITING

Rambam Health Care Campus ( Site 1422)

Haifa, 3109601, Israel

RECRUITING

Edith Wolfson Medical Center ( Site 1423)

Holon, 5810001, Israel

RECRUITING

Sheba Medical Center ( Site 1421)

Ramat Gan, 5265601, Israel

RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1501)

Brescia, 25123, Italy

RECRUITING

ASST DI LECCO ( Site 1509)

Lecco, 23900, Italy

RECRUITING

Istituto Nazionale dei Tumori ( Site 1504)

Milan, 20133, Italy

RECRUITING

Istituto Europeo di Oncologia ( Site 1503)

Milan, 20141, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1510)

Roma, 00168, Italy

RECRUITING

Kurume University Hospital ( Site 1615)

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Gunma Prefectural Cancer Center ( Site 1605)

Ōta, Gunma, 373-8550, Japan

RECRUITING

Hokkaido University Hospital ( Site 1609)

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

Hyogo Cancer Center ( Site 1620)

Akashi, Hyōgo, 673-8558, Japan

RECRUITING

Iwate Medical University Hospital ( Site 1610)

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

Saitama Medical University International Medical Center ( Site 1607)

Hidaka, Saitama, 350-1298, Japan

RECRUITING

Shizuoka Cancer Center ( Site 1618)

Sunto-gun,, Shizuoka, 411-8777, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 1614)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Keio University Hospital ( Site 1611)

Shinjyuku, Tokyo, 160-8582, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center ( Site 1603)

Fukuoka, 811-1395, Japan

RECRUITING

Kagoshima City Hospital ( Site 1613)

Kagoshima, 890-8760, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 1608)

Niigata, 951-8566, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 1604)

Osaka, 541-8567, Japan

RECRUITING

Stavanger Universitetssjukehus ( Site 2002)

Stavanger, Rogaland, 4068, Norway

RECRUITING

Sorlandet Sykehus Kristiansand ( Site 2003)

Kristiansand, Vest-Agder, 4615, Norway

RECRUITING

Oslo University Hospital ( Site 2001)

Oslo, 0424, Norway

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 2106)

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie ( Site 2105)

Poznan, Greater Poland Voivodeship, 61-866, Poland

RECRUITING

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)

Siedlce, Masovian Voivodeship, 08-110, Poland

RECRUITING

Bialostockie Centrum Onkologii ( Site 2104)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny nr2 PUM w Szczecinie ( Site 2103)

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

RECRUITING

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, 03722, South Korea

RECRUITING

Keimyung University Dongsan Hospital ( Site 2304)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

RECRUITING

Seoul National University Hospital ( Site 2301)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 2305)

Seoul, 05505, 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

Complejo Hospitalario Universitario A Coruna ( Site 2412)

A Coruña, La Coruna, 15006, Spain

RECRUITING

Clinica Universidad de Navarra ( Site 2407)

Madrid, Madrid, Comunidad de, 28027, Spain

RECRUITING

Instituto Valenciano de Oncologia - IVO ( Site 2411)

Valencia, Valenciana, Comunitat, 46009, 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 La Paz-Oncología Médica ( Site 2404)

Madrid, 28046, Spain

RECRUITING

Karolinska Universitetssjukhuset Solna ( Site 2502)

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

Inselspital Bern ( Site 3504)

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Ospedale Regionale Bellinzona e Valli ( Site 3501)

Bellinzona, Canton Ticino, 6500, Switzerland

RECRUITING

Kantonsspital Graubünden ( Site 3503)

Chur, Kanton Graubünden, 7000, Switzerland

RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 3502)

Geneva, 1205, Switzerland

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

Linkou Chang Gung Memorial Hospital ( Site 2605)

Taoyuan, 333, Taiwan

RECRUITING

Ramathibodi Hospital. ( Site 3402)

Bangkok, Bangkok, 10400, Thailand

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 3401)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 3403)

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Addenbrookes Hospital ( Site 2802)

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

RECRUITING

University Hospitals of Leicester NHS Trust ( Site 2805)

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

University College London Hospitals ( Site 2801)

London, London, City of, NW1 2PG, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 2804)

Manchester, m20 4bx, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Bevacizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 6, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): February 25, 2033
• Study Completion (Estimated): February 25, 2033
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

CL (4); GR (3); SE (1); FR (7); BR (4); TH (3); PL (5); BE (3); AU (2); CH (4); DK (4); NO (3); FI (4); ES (11); CZ (6); KR (5); TW (5); IL (3); US (14); IT (5); JP (13); HU (4); CA (2); AR (8); GB (4); CO (5); IE (1)