Идёт набор NCT06535607

Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors

Фаза II С лечением Sub-study 1 Cervical Cancer (Volrustomig Monotherapy) Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy) Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy) Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy)

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, Cisplatin, Carboplatin, Paclitaxel.
Кому может быть актуально: Состояния в реестре: Sub-study 1 Cervical Cancer (Volrustomig Monotherapy), Sub-study 2 Head and Neck Squamous Cell Carcinoma (Volrustomig Monotherapy), Sub-study 3 Head and Neck Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy), Sub-study 4 Esophageal Squamous Cell Carcinoma (Volrustomig in Combination With Chemotherapy). Базовые параметры: от 18 лет · Все.
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, Бразилия, Канада, Китай +7
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 II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors

Обзор

eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.

Подробное описание

eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors.

In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer.

In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma.

In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma.

In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.

Вмешательства

Биопрепарат Volrustomig
IV Infusion
Препарат Cisplatin
IV Infusion
Препарат Carboplatin
IV Infusion
Препарат Paclitaxel
IV Infusion
Препарат 5-FU
IV Infusion

Первичные конечные точки

Objective response rate (ORR) [Срок оценки: Through study completion, an average of 4 years]
The number of participants with adverse events/serious adverse events [Срок оценки: Through study completion, an average of 4 years]

Вторичные конечные точки (9)

Duration Of Response (DOR) [Срок оценки: Through study completion, an average of 4 years]
Progression free survival (PFS) [Срок оценки: Through study completion, an average of 4 years]
Time to response (TTR) [Срок оценки: Through study completion, an average of 4 years]
Overall Survival (OS) [Срок оценки: Through study completion, an average of 4 years]
PK of volrustomig [Срок оценки: Through study completion, an average of 4 years]
The immunogenicity of volrustomig [Срок оценки: Through study completion, an average of 4 years]
Disease control rate (DCR) [Срок оценки: Through study completion, an average of 4 years]
PFS landmark [Срок оценки: Through study completion, an average of 4 years]
OS landmark [Срок оценки: Through study completion, an average of 4 years]

Критерии участия

Критерии включения

Age ≥18 at the time of signing the ICF.
Provision of tumor sample to assess the PD-L1 expression (if applicable).
ECOG performance status of 0 or 1.
Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
Life expectancy ≥ 12 weeks.
Adequate organ and bone marrow function.
Body weight \> 35 kg
Capable of giving signed informed consent.

Критерии исключения

Spinal cord compression.
For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. For sub-study 5, participants with untreated or progressive brain metastases.
For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria.
Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
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 and of low potential risk for recurrence; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
Any evidence of diseases, and/or history of organ transplant or allogenic stem cell transplant, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
Evidence of the following infections: active infection including tuberculosis; known HIV infection. that is not well controlled; active or uncontrolled HBV or HCV; or active hepatitis A.
History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
Participants who are candidates for curative therapy.
Prior exposure to any immune-mediated therapy.
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).
For sub-study 1,2,3,4, participants are ineligible if they have received any anti-cancer therapy within 28 days prior to the first dose of study intervention or within 5 half-lives of the respective agent, whichever is longer.
Any concurrent chemotherapy except study intervention, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment.
Radiotherapy treatment with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.
Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
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 any study intervention, on any excipients of any study intervention.
For substudy 5: Participants with any prior systemic therapy, non-palliative radiotherapy, radical pleuropneumonectomy for pleural mesothelioma.

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

Китай · 50 центров

Research Site — Anyang
Research Site — Пекин
Research Site — Пекин
Research Site — Пекин
Research Site — Пекин
Research Site — Пекин
Research Site — Bengbu
Research Site — Changchun
… и ещё 42 центра

Германия · 10 центров

Research Site — Cologne
Research Site — Frankfurt
Research Site — Gauting
Research Site — Großhansdorf
Research Site — Hamburg
Research Site — Heidelberg
Research Site — Mainz
Research Site — Münster
… и ещё 2 центра

Бразилия · 8 центров

Research Site — Ijuí
Research Site — Londrina
Research Site — Natal
Research Site — Porto Alegre
Research Site — Santo André
Research Site — São Caetano do Sul
Research Site — Vitória
Research Site — Vitória

США · 6 центров

Research Site — Los Angeles
Research Site — Baltimore
Research Site — New York
Research Site — Stony Brook
Research Site — Columbus
Research Site — Philadelphia

Тайвань · 5 центров