A Study to Assess Adverse Events and Change in Disease Activity in Participants With Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression Treated With Intravenously (IV) Infused Mirvetuximab Soravtansine

Официальное название

A Randomized Phase 2, Open-label Study of Mirvetuximab Soravtansine in Patients With Platinum-resistant Advanced High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-alpha Expression Testing 2 Schedules of Administration for Dose Optimization, With a Separate Cohort to Determine Starting Dose in Patients With Moderate Hepatic Impairment

Обзор

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of for Mirvetuximab Soravtansine in participants with platinum-resistant advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer (platinum-resistant ovarian cancer) (PROC) whose tumors express a high level of folate receptor alpha (FRα). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). There are 2 cohorts in this study, the Randomized Phase 2 Cohort and the Hepatic Impairment Cohort. In the Randomized Phase 2 Cohort, participants are placed in 1 of 2 groups, called treatment arms. Each treatment arm receives MIRV on a different schedule (on day 1 every 21 days or on days 1 and 15 every 28 days). The Hepatic Impairment Cohort is designed to determine the starting dose of MIRV in patients with moderately abnormal liver function. Around 110 participants will be enrolled in the study at approximately 75 sites worldwide. The total study duration will be approximately 24 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Вмешательства

• Препарат Mirvetuximab Soravtansine
  intravenous (IV) infusion

Первичные конечные точки

• Randomized Phase 2 Cohort: Percentage of Participants with Grade >= 2 Treatment-Emergent Corneal Adverse Events (AEs) [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Percentage of Participants who Achieved Objective response rate (ORR) [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Time to Maximal Concentration (Tmax) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Hepatic Impairment Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]

Вторичные конечные точки (12)

• Randomized Phase 2 Cohort: Percentage of Participants with Treatment-Emergent All-Grade Ocular AEs, Grade >= 2 Peripheral Neuropathy, All-Grade Infusion Reactions, and All-Grade Pneumonitis [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Progression-Free Survival (PFS) [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Overall Survival (OS) [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Maximal Concentration (Cmax) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Area Under the Plasma Concentration (AUC) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Trough Concentration (Ctrough) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Time to Maximal Observed Concentration (Tmax) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Randomized Phase 2 Cohort: Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine [Срок оценки: Up to Approximately 24 months]
• Both Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to Approximately 24 months]

Критерии участия

Критерии включения

Both Cohorts

• Participants with a confirmed diagnosis of high-grade serous epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
• Participants with platinum-resistant disease:

• Participants with 1 prior line of platinum-based therapy who have received ≥ 4 cycles of platinum and had a response (complete response (CR) or partial response (PR)) followed by radiological progressive disease (PD) between > 3 months and ≤ 6 months after the date of the last dose of platinum.
• Participants with 2 or 3 prior lines of platinum-based therapy who had radiological PD ≤ 6 months after the date of the last dose of platinum.
• Participants with progression diagnosed radiographically on or after their most recent line of therapy.
• Participants with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Participants with ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically measured by the investigator).
• Participants with a tumor that is positive for folate receptor alpha (FRα) expression as determined by the Ventana folate receptor 1 (FOLR1) assay (≥ 75% of tumor staining at 2+ intensity).

Критерии исключения

Both Cohorts

• Participants with endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the above histologies; or low-grade or borderline ovarian tumor.
• Participants with primary platinum-refractory disease, defined as disease that did not respond (complete response (CR) or partial response (PR)) or that progressed radiographically within 3 months of the last dose of first-line platinum-containing chemotherapy.
• Participants with serious concurrent illness or clinically relevant active infection as outlined in the protocol
• Participants with a history of hemorrhagic or ischemic stroke within 6 months prior to randomization.

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

Испания · 11 центров

• Hospital Universitario Germans Trias i Pujol /ID# 272216 — Badalona
• Hospital Universitario de Jaén /ID# 272205 — Jaén
• Hospital Clínico Universitario Virgen de la Arrixaca /ID# 272223 — El Palmar
• Clinica Universidad de Navarra - Pamplona /ID# 275742 — Pamplona
• Hospital Universitario Virgen del Rocio /ID# 272107 — Seville
• Hospital Universitario Vall de Hebron /ID# 272134 — Barcelona
• Hospital General Universitario Gregorio Maranon /ID# 272121 — Madrid
• CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 272221 — Madrid
• … и ещё 3 центра

South Korea · 9 центров

• National Cancer Center /ID# 272265 — Goyang-si
• CHA Bundang Medical Center /ID# 271590 — Seongnam
• Seoul National University Bundang Hospital /ID# 271594 — Seongnam-si
• Keimyung University Dongsan Hospital /ID# 271592 — Daegu
• Seoul National University Hospital /ID# 272264 — Seoul
• Yonsei University Health System Severance Hospital /ID# 271593 — Seoul
• Asan Medical Center /ID# 272130 — Seoul
• Gangnam Severance Hospital /ID# 272217 — Seoul
• … и ещё 1 центр

Франция · 8 центров

• Centre Francois Baclesse /ID# 272204 — Caen
• Centre Armoricain De Radiothérapie, D'Imagerie Médicale Et D'Oncologie (Cario) /ID# 272201 — Plérin
• Institut De Cancérologie De Lorraine Alexis Vautrin /ID# 272147 — Vandœuvre-lès-Nancy
• Centre Oscar Lambret /ID# 272183 — Lille
• Centre Antoine-Lacassagne /ID# 272101 — Nice
• HCL - Hopital Lyon Sud /ID# 272178 — Pierre-Bénite
• Centre Hospitalier Departemental Vendee (Chd Vendee) /ID# 272174 — La Roche-sur-Yon
• GH Diaconesses Croix Saint Simon-Hopital De La Croix Saint-Simon /ID# 272179 — Paris

США · 7 центров

• First Physicians Group /ID# 272180 — Sarasota
• St. Elizabeth Medical Center - Edgewood /ID# 272113 — Edgewood
• Baptist Health Lexington /ID# 272211 — Lexington
• UMass Memorial Medical Center - Belmont Street /ID# 272122 — Worcester
• Karmanos Cancer Institute - Detroit /ID# 272112 — Detroit
• Allegheny Health Network West Penn Hospital /ID# 272267 — Pittsburgh
• Memorial Hermann Texas Medical Center /ID# 272227 — Houston

Австралия · 7 центров

• Blacktown Hospital /ID# 272182 — Blacktown
• Newcastle Private Hosptial /ID# 272213 — Lambton Heights
• Royal Brisbane and Women's Hospital /ID# 272123 — Brisbane
• Icon Cancer Centre Chermside /ID# 272220 — Chermside
• Ballarat Base Hospital /ID# 272240 — Ballarat
• Monash Health - Monash Medical Centre - Clayton /ID# 272234 — Clayton
• Sir Charles Gairdner Hospital /ID# 272116 — Nedlands

Бельгия · 5 центров

• Algemeen Ziekenhuis klina /ID# 272127 — Brasschaat
• Cliniques Universitaires UCL Saint-Luc /ID# 272219 — Brussels
• AZ Maria Middelares /ID# 272186 — Ghent
• Universitair Ziekenhuis Leuven /ID# 277350 — Leuven
• AZ-Delta /ID# 272250 — Roeselare

Великобритания · 3 центра

• Addenbrookes Hospital /ID# 272162 — Cambridge
• Royal Devon and Exeter Hospital /ID# 272170 — Exeter
• University College London Hospital /ID# 272115 — London

Польша · 2 центра

• Mazowiecki Szpital Wojewodzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. /ID# 271692 — Siedlce
• Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku /ID# 272169 — Bialystok

Идентификаторы

NCT: NCT06682988 · IMGN853-0425 · 2024-517184-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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