Език: EN EN
← Назад към резултатите
Набира участници Фаза 3 NCT07216703

A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Cervical Cancer

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body. Researchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and * If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment
Описание
This is a 2-part study. In Part 1 Safety Run-in, eligible participants will be allocated to treatment with sac-TMT + pembrolizumab + bevacizumab. In Part 2, all participants receive standard of care induction treatment. Eligible participants whose cancer does not progress then begin maintenance treatment and are randomized to receive pembrolizumab or sac-TMT + pembrolizumab. All participants in Part 2 maintenance treatment may also receive bevacizumab at the investigator's discretion.
Кой може да участва
The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix * Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \[FIGO\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation) * If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy * If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load * Has an Eastern Cooperative Oncology Group performance status of 0 or 1 * Has tumor programmed cell death ligand 1 expression of combined positive score ≥1 The main exclusion criteria include but are not limited to the following: * Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has a 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has received prior systemic anticancer therapy other than what is specified in this protocol * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT * Has a diagnosis of immunodeficiency * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system metastases and/or carcinomatous meningitis * Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Интервенции
Pembrolizumab
BIOLOGICAL
Sacituzumab Tirumotecan
BIOLOGICAL
Bevacizumab
BIOLOGICAL
Paclitaxel
DRUG
Cisplatin
DRUG
Carboplatin
DRUG
Rescue Medications
DRUG
Места на провеждане 86
Argentina (5)
Fundación Respirar ( Site 0101)
Belgrano , Buenos Aires F.D.
Study Coordinator
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)
La Rioja
Study Coordinator
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)
Mar del Plata , Buenos Aires
Study Coordinator
Instituto de Oncologia de Rosario ( Site 0104)
Rosario , Santa Fe Province
Study Coordinator
Hospital Provincial del Centenario ( Site 0106)
Rosario , Santa Fe Province
Study Coordinator
Белгия (5)
Cliniques Universitaires Saint-Luc ( Site 0402)
Brussels , Bruxelles-Capitale, Region de
Study Coordinator
Grand Hopital de Charleroi ( Site 0404)
Charleroi , Hainaut
Study Coordinator
Antwerp University Hospital ( Site 0407)
Edegem , Antwerpen
Study Coordinator
UZ Gent ( Site 0406)
Ghent , Oost-Vlaanderen
Study Coordinator
UZ Leuven ( Site 0401)
Leuven , Vlaams-Brabant
Study Coordinator
Бразилия (4)
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0511)
Barretos , São Paulo
Study Coordinator
Hospital São Lucas da PUCRS ( Site 0516)
Porto Alegre , Rio Grande do Sul
Study Coordinator
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0512)
São José do Rio Preto , São Paulo
Study Coordinator
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0517)
São Paulo , São Paulo
Study Coordinator
Канада (5)
Centre Hospitalier de l'Université de Montréal ( Site 0616)
Montreal , Quebec
Study Coordinator
McGill University Health Centre ( Site 0602)
Montreal , Quebec
Study Coordinator
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0611)
Québec , Quebec
Study Coordinator
CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0604)
Sherbrooke , Quebec
Study Coordinator
Princess Margaret Cancer Centre ( Site 0601)
Toronto , Ontario
Study Coordinator
Colombia (5)
Centro Cancerológico del Caribe (CECAC) ( Site 0906)
Barranquilla , Atlántico
Study Coordinator
Instituto Nacional De Cancerologia ( Site 0909)
Bogotá , Bogota D.C.
Study Coordinator
Oncomédica S.A.S ( Site 0905)
Montería , Departamento de Córdoba
Study Coordinator
Oncólogos del Occidente S.A.S. ( Site 0908)
Pereira , Risaralda Department
Study Coordinator
Clinica Somer ( Site 0903)
Rionegro , Antioquia
Study Coordinator
Чехия (4)
Nemocnice AGEL Novy Jicin a.s. ( Site 1004)
Nový Jičín , Moravian-Silesian Region
Study Coordinator
Fakultni nemocnice Ostrava ( Site 1005)
Ostrava , Moravian-Silesian Region
Study Coordinator
Fakultni nemocnice Kralovske Vinohrady ( Site 1002)
Prague , Praha 10
Study Coordinator
Vseobecna fakultni nemocnice v Praze-Gynekologicko-porodnicka klinika 1.LF a VFN ( Site 1001)
Prague
Study Coordinator
Гърция (3)
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 1401)
Athens , Attica
Study Coordinator
Aretaieio Hospital Oncology Unit ( Site 1402)
Athens , Attica
Study Coordinator
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1403)
Chaïdári , Attica
Study Coordinator
Унгария (2)
Országos Onkológiai Intézet ( Site 1603)
Budapest
Study Coordinator
Debreceni Egyetem Klinikai Kozpont ( Site 1601)
Debrecen
Study Coordinator
Израел (6)
Hillel Yaffe Medical Center ( Site 1903)
Hadera
Study Coordinator
Rambam Health Care Campus ( Site 1907)
Haifa
Study Coordinator
Carmel Hospital ( Site 1901)
Haifa
Study Coordinator
Shaare Zedek Medical Center ( Site 1905)
Jerusalem
Study Coordinator
Rabin Medical Center ( Site 1904)
Petah Tikva
Study Coordinator
Sourasky Medical Center ( Site 1902)
Tel Aviv
Study Coordinator
Италия (7)
Ospedale Cannizzaro ( Site 2010)
Catania
Study Coordinator
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 2009)
Meldola , Forli-Cesena
Study Coordinator
Ospedale Humanitas San Pio X ( Site 2013)
Milan , Lombardy
Study Coordinator
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 2008)
Milan , Milano
Study Coordinator
Istituto Europeo di Oncologia ( Site 2003)
Milan
Study Coordinator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2012)
Roma
Study Coordinator
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 2006)
Torino
Study Coordinator
Япония (8)
Hyogo Cancer Center ( Site 2118)
Akashi , Hyōgo
Study Coordinator
University of the Ryukyus Hospital ( Site 2117)
Ginowan , Okinawa
Study Coordinator
Saitama Medical University International Medical Center ( Site 2106)
Hidaka , Saitama
Study Coordinator
Cancer Institute Hospital of JFCR ( Site 2119)
Koto , Tokyo
Study Coordinator
Niigata Cancer Center Hospital ( Site 2110)
Niigata
Study Coordinator
Okayama University Hospital ( Site 2101)
Okayama
Study Coordinator
National Hospital Organization Hokkaido Cancer Center ( Site 2108)
Sapporo , Hokkaido
Study Coordinator
Iwate Medical University Hospital ( Site 2116)
Shiwa-gun , Iwate
Study Coordinator
Полша (3)
Narodowy Instytut Onkologii - Oddzial w Gliwicach-III Klinika Radioterapii i Chemioterapii ( Site 2604)
Gliwice , Silesian Voivodeship
Study Coordinator
Swietokrzyskie Centrum Onkologii. ( Site 2602)
Kielce , Świętokrzyskie Voivodeship
Study Coordinator
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 2601)
Siedlce , Warmian-Masurian Voivodeship
Study Coordinator
Южна Корея (5)
National Cancer Center ( Site 2905)
Goyang-si , Kyonggi-do
Study Coordinator
Seoul National University Hospital ( Site 2901)
Jongno-gu , Seoul
Study Coordinator
Severance Hospital Yonsei University Health System ( Site 2902)
Seodaemun-Gu , Seoul
Study Coordinator
Asan Medical Center ( Site 2904)
Seoul
Study Coordinator
Samsung Medical Center ( Site 2903)
Seoul
Study Coordinator
Испания (6)
Hospital Universitari Vall d Hebron ( Site 3003)
Barcelona
Study Coordinator
Hospital Universitario Reina Sofia ( Site 3006)
Córdoba
Study Coordinator
Institut Català d'Oncologia (ICO) - Girona ( Site 3002)
Girona , Gerona
Study Coordinator
Hospital Ramon y Cajal ( Site 3005)
Madrid
Study Coordinator
Hospital Universitario 12 de Octubre ( Site 3007)
Madrid
Study Coordinator
Hospital Universitario La Paz ( Site 3004)
Madrid
Study Coordinator
Швеция (3)
Linköping University Hospital ( Site 3101)
Linköping , Östergötland County
Study Coordinator
Skanes Universitetssjukhus Lund ( Site 3103)
Lund , Skåne County
Study Coordinator
Karolinska Universitetssjukhuset-Solna ( Site 3102)
Stockholm , Stockholm County
Study Coordinator
Taiwan (5)
Taichung Veterans General Hospital ( Site 3304)
Taichung
Study Coordinator
National Cheng Kung University Hospital ( Site 3308)
Tainan
Study Coordinator
Mackay Memorial Hospital ( Site 3303)
Taipei
Study Coordinator
National Taiwan University Hospital ( Site 3301)
Taiwan , Taipei
Study Coordinator
Chang Gung Memorial Hospital ( Site 3302)
Taoyuan District
Study Coordinator
САЩ (10)
University of Virginia Cancer Center ( Site 6014)
Charlottesville , Virginia
Study Coordinator
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)
Eugene , Oregon
Study Coordinator
Texas Oncology - DFW ( Site 8005)
Fort Worth , Texas
Study Coordinator
University of Tennessee Medical Center ( Site 6012)
Knoxville , Tennessee
Study Coordinator
Women's Cancer Center of Nevada ( Site 6011)
Las Vegas , Nevada
Study Coordinator
Mount Sinai Comprehensive Cancer Center ( Site 6000)
Miami Beach , Florida
Study Coordinator
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)
New York , New York
Study Coordinator
TRIALS 365 ( Site 6008)
Shreveport , Louisiana
Study Coordinator
Texas Oncology-The Woodlands ( Site 8000)
The Woodlands , Texas
Study Coordinator
Texas Oncology - Northeast Texas ( Site 8002)
Tyler , Texas
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
19.01.2026
Крайна дата
29.10.2031
Регистрационен номер
NCT07216703
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.