Идёт набор NCT06819007

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)

Фаза III С лечением Ovarian Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Trastuzumab Deruxtecan, Bevacizumab.
Кому может быть актуально: Состояния в реестре: Ovarian Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Австрия, Бельгия, Бразилия +20
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144- O/GOG-3112/APGOT-OV13)

Обзор

This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \[IHC\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.

Подробное описание

A non-randomized safety run-in phase will be conducted prior to randomization phase to assess the safety of T-DXd in combination with bevacizumab.

Вмешательства

Препарат Trastuzumab Deruxtecan
T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)
Препарат Bevacizumab
Bevacizumab will be administered at a dose of 15/mg/kg IV Q3W

Первичные конечные точки

Progression Free Survival by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ population [Срок оценки: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months]

Вторичные конечные точки (5)

Overall Survival in the HER2 IHC 3+/2+ population [Срок оценки: From date of randomization to death due to any cause, up to approximately 72 months]
Progression Free Survival by BICR in the HER2 IHC 3+/2+/1+ population [Срок оценки: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months]
Overall Survival in the HER2 IHC 3+/2+/1+ population [Срок оценки: From date of randomization to death due to any cause, up to approximately 72 months]
Progression Free Survival by the investigator in HER2 IHC 3+/2+ population [Срок оценки: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months]
Progression Free Survival by the investigator in HER2 IHC 3+/2+/1+ population [Срок оценки: From date of randomization to radiographic disease progression or death due to any cause, up to approximately 35 months]

Критерии участия

Критерии включения

Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.

\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.

Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is >18 years old.
Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
Is newly diagnosed FIGO Stage III or IV.
Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing.

\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \[IHC 3+/2+/1+\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.

Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.

\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.

Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.
Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.

Критерии исключения

Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.
Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.
Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:

HRD negative
HRD positive with SD as best response after platinum
HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea
HRD tested, but inconclusive
HRD positive but safety concern (safety concern to be specified).
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.
Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.

\*Note: For participants enrolled from the Republic of Korea,

Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).
Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.
Evidence of active or ongoing bowel obstruction.
Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).

Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.

Has a corrected QT interval prolongation to >480 msec based on average of the Screening triplicate 12-lead ECG.
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

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 · 32 центра

Disney Family Cancer Center — Burbank
Scripps Clinic — La Jolla
Palo Alto Medical Foundation — Palo Alto
Broward Health Medical Center — Fort Lauderdale
Jupiter Medical Center — Jupiter
Mount Sinai Medical Center — Miami Beach
AdventHealth Cancer Institute — Orlando
Woman's Care FL — St. Petersburg
… и ещё 24 центра

Китай · 27 центров

Beijing Cancer Hospital — Пекин
The First Hospital of Jilin University — Changchun
Hunan Cancer Hospital — Чанша
Sichuan University West China Second University Hospital — Чэнду
Chongqing Cancer Hospital — Чунцин
The Second Hospital of Dalian Medical University — Dalian
Fujian Cancer Hospital — Фучжоу
Sun Yat-Sen University Cancer Center — Гуанчжоу
… и ещё 19 центров

Япония · 16 центров