Идёт набор NCT06079671

Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)

Фаза III С лечением Locally Advanced Cervical 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: Volrustomig, Placebo.
Кому может быть актуально: Состояния в реестре: Locally Advanced Cervical Cancer. Базовые параметры: от 15 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, Бразилия, Канада, Китай, Дания +14
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 III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Обзор

This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.

Подробное описание

Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.

Вмешательства

Биопрепарат Volrustomig
IV Infusion
Другое Placebo
IV Infusion

Первичные конечные точки

Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS) [Срок оценки: Up to approximately 7 years]

Вторичные конечные точки (12)

Overall Survival (OS) in all randomized participants [Срок оценки: Up to approximately 7 years]
Objective Response Rate (ORR) in all randomized participants [Срок оценки: Up to approximately 7 years]
Duration of Response (DoR) in all randomized participants [Срок оценки: Up to approximately 7 years]
Time to First Subsequent Therapy or death (TFST) in all randomized participants [Срок оценки: Up to approximately 7 years]
Time to second progression or death (PFS2) in all randomized participants [Срок оценки: Up to approximately 7 years]
PFS by BICR in all randomized participants [Срок оценки: Up to approximately 7 years]
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants [Срок оценки: Up to approximately 7 years]
PK of volrustomig [Срок оценки: Up to approximately 7 years]
The immunogenicity of volrustomig [Срок оценки: Up to approximately 7 years]
Incidence of adverse events of volrustomig compared to placebo [Срок оценки: Up to approximately 7 years]
Participant-reported disease-related symptoms [Срок оценки: Up to approximately 7 years]
Participant-reported physical functioning [Срок оценки: Up to approximately 7 years]

Критерии участия

Критерии включения

For inclusion in the study, patients should fulfill the following criteria:

Female.
Aged at least 15 years at the time of screening. Note: Participants < 18 years of age: physical changes should be aligned with Tanner Stage III.
Body weight > 35 kg.
Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
Provision of FFPE tumor sample to assess the PD-L1 expression.
Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.
Adequate organ and bone marrow function.
Capable of providing signed informed consent.

Критерии исключения

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
Evidence of metastatic disease.
Intent to administer a fertility-sparing treatment regimen.
History of organ transplant or allogenic stem cell transplant.
History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
Uncontrolled intercurrent illness.
History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
History of anaphylaxis to any biologic therapy or vaccine.
Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
Exposure to immune mediated therapy prior to the study for any indication.
Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.

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: Четверное слепое
Основная цель: Лечение

Центры проведения

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