A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Официальное название

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate GLS-010 Plus Platinum-containing Chemotherapy With or Without Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer

Обзор

This is a randomized, double-blind, placebo-controlled phase III study to evaluate GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

Подробное описание

This is a randomized, double-blind, placebo-controlled phase III study，aimed to evaluate the efficacy and safety of GLS-010 plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer.All enrolled patients will be randomly divided into 2 groups and continuously treated until any event that meets the criteria for end of the clinical trial.

Вмешательства

• Препарат GLS-010
  IV infusion
• Препарат Placebo
  IV infusion
• Препарат paclitaxel
  IV infusion
• Препарат cisplatin
  IV infusion
• Препарат carboplatin
  IV infusion
• Препарат bevacizumab
  IV infusion

Первичные конечные точки

• overall survival (OS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (7)

• progression-free survival (PFS) [Срок оценки: Up to 2 years]
• Objective Response Rate (ORR) [Срок оценки: Up to 2 years]
• Duration of Response (DOR) [Срок оценки: Up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to 2 years]
• Time to Response（TTR） [Срок оценки: Up to 2 years]
• Number of subjects with adverse events (AEs) [Срок оценки: From the time of signed informed consent to 90 days after end of treatment.]
• Quality of life (QoL) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Signed the informed consent form.
• Women aged ≥ 18 and ≤ 75 years.
• ECOG of 0 or 1.
• Life expectancy ≥ 12 weeks.
• Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1),.The histological types include squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma.
• No prior systemic therapy for persistent, recurrent or metastatic (\[FIGO\] Stage IVB) disease,not amenable to curative surgery or concurrent chemoradiotherapy.
• At least one measurable tumor lesion per RECIST v1.1; lesions previously treated with radiotherapy or other loco-regional therapy are not considered as target lesions unless the lesion has unequivocal progression or the biopsy is obtained to confirm maligancy.
• Subjects must have adequate organ function.
• Female subjects of childbearing potential must have a negative serum pregnancy test prior to the first dose. Female subject of childbearing potential must use acceptable effective methods of contraception from screening and must agree to continue these precautions until 6 months after the last dose of study drug.

Критерии исключения

• Patients with the opportunity to be cured by surgery and radiotherapy.
• Received with concurrent chemoradiotherapy, adjuvant chemotherapy,neo- adjuvant chemotherapy within 4 weeks prior to randomization.
• Active central nervous system (CNS) metastasis.
• Patients with other malignancies prior to randomization. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast cancer) that have been cured are not excluded.
• Has an active autoimmune disease that has required systemic treatment.
• With active serious infections.
• Subjects with HIV infection ,active hepatitis B virus infection, active hepatitis C virus infection,active tuberculosis infection,active syphilis .
• Has not recovered adequately from toxicity and/or complications from surgery prior to randomization.
• . .
• Has a contraindication or hypersensitivity to any component of cisplatin, carboplatin, paclitaxel, or bevacizumab.
• Have received any investigational treatment in other clinical trials within 4 weeks prior to randomization.
• Pregnant or lactating women,or women may become pregnant during treatment.
• Has had an allogeneic tissue/solid organ/ hematopoietic stem cells transplant.
• History of nervous system and mental disease. History of drug abuse.
• The patient is not suitable to participate the study in the opinion of the investigator.

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

Китай · 1 центр

• Fudan University Shanghai Cancer Hospital — Шанхай

Идентификаторы

NCT: NCT05798819 · GLS-010-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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