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Набира участници Фаза 3 NCT06824467

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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Места на провеждане 26
Argentina (1)
Instituto Alexander Fleming ( Site 2909)
Ciudad Autónoma de Buenos Aires , Buenos Aires
Study Coordinator
Австралия (1)
Blacktown Hospital ( Site 0211)
Sydney , New South Wales
Study Coordinator
Белгия (1)
Antwerp University Hospital ( Site 0304)
Edegem , Antwerpen
Study Coordinator
Бразилия (1)
Liga Norte Riograndense Contra o Cancer ( Site 0423)
Natal , Rio Grande do Norte
Study Coordinator
Канада (1)
Princess Margaret Cancer Centre ( Site 0518)
Toronto , Ontario
Study Coordinator
Chile (1)
Clinica Puerto Montt ( Site 0615)
Port Montt , Los Lagos Region
Study Coordinator
Colombia (1)
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0806)
Bogotá , Bogota D.C.
Study Coordinator
Чехия (1)
Fakultni nemocnice Ostrava ( Site 3323)
Ostrava-Poruba , Ostrava Mesto
Study Coordinator
Дания (1)
Rigshospitalet ( Site 0904)
Copenhagen , Capital Region
Study Coordinator
Финландия (1)
Oulun yliopistollinen sairaala ( Site 1003)
Oulu , North Ostrobothnia
Study Coordinator
Франция (1)
Centre Oscar Lambret ( Site 1104)
Lille , Ain
Study Coordinator
Гърция (1)
Aretaieio Hospital ( Site 0701)
Athens , Attica
Study Coordinator
Унгария (1)
Bacs-Kiskun Megyei Korhaz ( Site 3920)
Kecskemét , Bács-Kiskun county
Study Coordinator
Израел (1)
Hillel Yaffe Medical Center ( Site 1404)
Hadera
Study Coordinator
Италия (1)
CRO-IRCCS ( Site 1510)
Aviano , Friuli Venezia Giulia
Study Coordinator
Япония (1)
Aichi Cancer Center ( Site 1626)
Nagoya , Aichi-ken
Study Coordinator
Mexico (1)
CIO - Centro de Inmuno-Oncología de Occidente ( Site 1719)
Guadalajara , Jalisco
Study Coordinator
Peru (1)
Hospital Guillermo Almenara Irigoyen ( Site 3608)
Lima
Study Coordinator
Полша (1)
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2106)
Poznan , Greater Poland Voivodeship
Study Coordinator
Румъния (1)
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2215)
Cluj-Napoca , Cluj
Study Coordinator
Южна Корея (1)
National Cancer Center ( Site 2305)
Goyang-si , Kyonggi-do
Study Coordinator
Испания (1)
Institut Català d'Oncologia (ICO) - Girona ( Site 2402)
Girona , Gerona
Study Coordinator
Taiwan (1)
Taichung Veterans General Hospital ( Site 2603)
Taichung
Study Coordinator
Тайланд (1)
Ramathibodi Hospital ( Site 3402)
Bangkok , Bangkok
Study Coordinator
Великобритания (1)
Western General Hospital ( Site 2806)
Edinburgh , Edinburgh, City of
Study Coordinator
САЩ (1)
University of Alabama at Birmingham ( Site 0006)
Birmingham , Alabama
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
09.04.2025
Крайна дата
09.11.2032
Регистрационен номер
NCT06824467
Източник
anzctr
Запитване за медицински туризъм

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