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)

Официальное название

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

Обзор

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.

Вмешательства

• Биопрепарат Sacituzumab tirumotecan
  IV Infusion
• Биопрепарат Bevacizumab
  IV Infusion
• Препарат H1 receptor antagonist
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Препарат H2 receptor antagonist
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Препарат Acetaminophen (or equivalent)
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Препарат Dexamethasone (or equivalent)
  Rescue medication taken per approved product label before sacituzumab tirumotecan
• Препарат Steroid mouthwash (dexamethasone or equivalent)
  Rescue medication taken orally 2-4 times daily

Первичные конечные точки

• Part 1: Number of Participants With One or More Adverse Events (AEs) [Срок оценки: Up to 6 weeks]
• Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to 6 weeks]
• Part 2: Progression-Free Survival (PFS) [Срок оценки: Up to approximately 4 years]

Вторичные конечные точки (7)

• Part 2: Overall Survival (OS) [Срок оценки: Up to approximately 6 years]
• Part 2: Number of Participants With One or More AEs [Срок оценки: Up to approximately 4 years]
• Part 2: Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: 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 [Срок оценки: Baseline and up to approximately 4 years]
• Part 2: Change From Baseline in EORTC QLQ-C30 Physical Functioning Score [Срок оценки: Baseline and up to approximately 4 years]
• Part 2: Change From Baseline in EORTC QLQ-C30 Role Functioning Score [Срок оценки: Baseline and up to approximately 4 years]
• Part 2: Change From Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale [Срок оценки: Baseline and up to approximately 4 years]

Критерии участия

Критерии включения

• Has locally advanced or metastatic, histologically confirmed 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 to 8 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)

Критерии исключения

• 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, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 34 центра

• University of Alabama at Birmingham ( Site 0006) — Birmingham
• Alaska Women's Cancer Care ( Site 0096) — Anchorage
• UCSF Medical Center at Mission Bay ( Site 0013) — San Francisco
• John Muir Health Cancer Center ( Site 0016) — Walnut Creek
• Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0001) — New Haven
• Mount Sinai Braman Comprehensive Cancer Center ( Site 0078) — Miami Beach
• Sarasota Memorial Hospital ( Site 0075) — Sarasota
• Florida Cancer Specialists East ( Site 7000) — West Palm Beach
• … и ещё 26 центров

Япония · 16 центров

Список центров уточняется — проверьте первичный протокол.

Испания · 12 центров

Список центров уточняется — проверьте первичный протокол.

Франция · 11 центров

Список центров уточняется — проверьте первичный протокол.

Италия · 11 центров

Список центров уточняется — проверьте первичный протокол.

Мексика · 9 центров

Список центров уточняется — проверьте первичный протокол.

Бразилия · 7 центров

• Liga Norte Riograndense Contra o Cancer ( Site 0423) — Natal
• Hospital São Lucas da PUCRS ( Site 0425) — Porto Alegre
• ANIMI - Unidade de Tratamento Oncologico ( Site 0419) — Lages
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0413) — São José do Rio Preto
• Instituto Nacional de Câncer - INCA ( Site 0422) — Rio de Janeiro
• Hospital Paulistano ( Site 0421) — São Paulo
• IBCC - Núcleo de Pesquisa e Ensino ( Site 0424) — São Paulo

Аргентина · 6 центров

• Instituto Alexander Fleming ( Site 2909) — Ciudad Autónoma de Buenos Aires
• Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901) — Mar del Plata
• Fundación Respirar ( Site 2912) — Buenos Aires
• Instituto de Oncologia de Rosario ( Site 2910) — Rosario
• Hospital Aleman ( Site 2903) — CABA
• Hospital Italiano de Cordoba ( Site 2908) — Córdoba

Перу · 6 центров

Список центров уточняется — проверьте первичный протокол.

Великобритания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Бельгия · 5 центров

• Antwerp University Hospital ( Site 0304) — Edegem
• Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 03 — Liège
• AZ Sint-Lucas ( Site 0305) — Ghent
• UZ Leuven ( Site 0301) — Leuven
• CHU UCL Namur/Site Sainte Elisabeth ( Site 0302) — Namur

Канада · 5 центров

• Arthur J.E. Child Comprehensive Cancer Centre ( Site 0512) — Calgary
• Trillium Health Partners - Credit Valley Hospital ( Site 0508) — Mississauga
• Princess Margaret Cancer Centre ( Site 0518) — Toronto
• CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0505) — Montreal
• McGill University Health Centre ( Site 0502) — Montreal

Венгрия · 5 центров

Список центров уточняется — проверьте первичный протокол.

Израиль · 5 центров

Список центров уточняется — проверьте первичный протокол.

Польша · 5 центров

Список центров уточняется — проверьте первичный протокол.

South Korea · 5 центров

Список центров уточняется — проверьте первичный протокол.

Тайвань · 5 центров

Список центров уточняется — проверьте первичный протокол.

Австралия · 4 центра

• Blacktown Hospital ( Site 0211) — Sydney
• Gallipoli Medical Research Ltd ( Site 0214) — Brisbane
• Epworth Freemasons ( Site 0217) — East Melbourne
• Frankston Hospital ( Site 0216) — Frankston

Чили · 4 центра

• Clinica Puerto Montt ( Site 0615) — Port Montt
• Pontificia Universidad Catolica de Chile ( Site 0611) — Santiago
• Bradfordhill-Clinical Area ( Site 0610) — Santiago
• ONCOCENTRO APYS-ACEREY ( Site 0612) — Viña del Mar

Чехия · 4 центра

• Fakultni Nemocnice Brno Bohunice ( Site 3324) — Brno
• Fakultni nemocnice Ostrava ( Site 3323) — Ostrava-Poruba
• Vseobecna fakultni nemocnice v Praze ( Site 3325) — Prague
• Fakultni nemocnice v Motole ( Site 3322) — Prague

Дания · 4 центра

• Rigshospitalet ( Site 0904) — Copenhagen
• Herlev Hospital ( Site 0903) — Herlev
• Aalborg Universitetshospital ( Site 0901) — Aalborg
• Vejle Sygehus ( Site 0902) — Vejle

Румыния · 4 центра

Список центров уточняется — проверьте первичный протокол.

Колумбия · 3 центра

• FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO AN — Bogotá
• Instituto Nacional De Cancerologia ( Site 0807) — Bogotá
• Oncologos Del Occidente ( Site 0805) — Pereira

Финляндия · 3 центра

• Oulun yliopistollinen sairaala ( Site 1003) — Oulu
• Kuopion Yliopistollinen Sairaala ( Site 1004) — Kuopio
• Tampereen yliopistollinen sairaala ( Site 1002) — Tampere

Греция · 2 центра

Список центров уточняется — проверьте первичный протокол.

Португалия · 2 центра

Список центров уточняется — проверьте первичный протокол.

Таиланд · 2 центра

Список центров уточняется — проверьте первичный протокол.

Австрия · 1 центр

• Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0104) — Graz

Ирландия · 1 центр

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06824467 · 2870-022 · MK-2870-022 · TroFuse-022 · 2023-508015-23-00 · U1111-1297-4489 · GOG-3103 · ENGOT-ov84 · jRCT2031240722

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗