Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Официальное название

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Обзор

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

Вмешательства

• Препарат INCB123667
  Oral; tablet
• Препарат Investigator's choice of chemotherapy
  The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Первичные конечные точки

• Progression-Free Survival (PFS) by BICR [Срок оценки: Up to 2 years]
• Overall Survival (OS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (10)

• Objective response by BICR [Срок оценки: Up to 2 years]
• Duration of Response (DOR) by BICR [Срок оценки: Up to 2 years]
• Progression-Free Survival (PFS) by investigator [Срок оценки: Up to 2 years]
• Objective response by investigator [Срок оценки: Up to 2 years]
• DOR by investigator [Срок оценки: Up to 2 years]
• Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 2 years and 30 days]
• TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment [Срок оценки: Up to 2 years and 30 days]
• Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at each postbaseline visit [Срок оценки: Up to 2 years]
• Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 28 (C28) score at each postbaseline visit [Срок оценки: Up to 2 years]
• Change from baseline in EQ-5D-5L score at each postbaseline visit [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Have platinum-resistant disease.

• Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum containing regimen.
• Participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum.
• Archival FFPE tumor tissue block or slides from a specimen no older than 5 years must be available. If not available, participant must be willing to undergo a pretreatment tumor biopsy.
• Received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent chemotherapy is considered an appropriate next therapeutic option.
• Should have received prior treatment with bevacizumab unless there was a contraindication for its use.
• Should have received prior treatment with mirvetuximab soravtansine if the tumor is positive for FRα, unless there is an exception for its use on medical grounds.
• Measurable disease per RECIST v1.1.

Критерии исключения

• Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer.
• Have primary platinum-refractory disease, defined as progression on or within 3 months after the last dose of first line platinum-containing therapy.
• Clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study treatment.
• Known active CNS metastases and/or carcinomatous meningitis.
• Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years before the first dose of study treatment.
• Clinically significant gastrointestinal abnormalities.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

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 · 48 центров

• Alaska Womens Cancer Care Akwcc — Anchorage
• University of Arizona Cancer Center — Tucson
• City of Hope Medical Center — Duarte
• Providence Medical Foundation — Fullerton
• University of California, San Diego-Moores Cancer Center — La Jolla
• Valkyrie Clinical Trials — Los Angeles
• Uci Health Chao Family Comprehensive Cancer Center — Orange
• Ventura County Hematology Oncology Specialists-Oxnard — Oxnard
• … и ещё 40 центров

Италия · 19 центров

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Япония · 15 центров

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South Korea · 15 центров

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Великобритания · 13 центров

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Франция · 12 центров

• Ch Davignon - Hopital Henri Duffaut — Avignon
• Clinique Tivoli — Bordeaux
• Clinique Pole Sante Leonard de Vinci — Chambray-lès-Tours
• Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies — La Roche-sur-Yon
• Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon — La Tronche
• Hopital Prive Jean Mermoz — Lyon
• Institut Paoli Calmettes — Marseille
• Centre Antoine Laccassagne — Nice
• … и ещё 4 центра

Испания · 11 центров

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Германия · 9 центров

• Charite Campus Virchow — Berlin
• Universitaetsklinikum Bonn — Bonn
• Universitaetsklinikum Dresden — Dresden
• … и ещё 6 центров

Бельгия · 6 центров

• Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet — Brussels
• Cliniques Universitaires St Luc Ucl — Brussels
• Az Maria Middelares Gent — Ghent
• UZ GENT — Ghent
• Az Groeninge — Kortrijk
• Universitair Ziekenhuis Leuven — Leuven

Канада · 6 центров

• Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary — Calgary
• Cross Cancer Insititute — Edmonton
• London Health Sciences Centre — London
• University Health Network (Uhn) - Princess Margaret Cancer Centre — Toronto
• Sir Mortimer B. Davis - Jewish General Hospital — Montreal
• Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site — Montreal

Швейцария · 6 центров

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Австралия · 5 центров

• Chris O'Brien Lifehouse Hospital — Camperdown
• The Wollongong Hospital — Wollongong
• Mater Hospital Brisbane — South Brisbane
• Icon Cancer Care - Townsville — Townsville
• Eastern Health-Box Hill Hospital — Box Hill

Ирландия · 5 центров

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Польша · 5 центров

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Нидерланды · 4 центра

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Пуэрто-Рико · 2 центра

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Идентификаторы

NCT: NCT07214779 · INCB123667-305 · 2025-522748-42-00 · GOG-3137 · ENGOT-OV95

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗