2024-519286-21-00招募中3 期
PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica14 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
研究概览
简要总结
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase Iii Study With Atezolizumab Versus Placebo In Malignant Pleural Mesothelioma Patients After Pl
- 盲法
- Double (Investigator, Subject, Monitor, Carer, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on day of signing informed consent • Histologically confirmed malignant pleural mesothelioma • Surgical resection (P/D), without macroscopic residual. In stage I patients without visceral involvement a total pleurectomy is allowed • Patients must have received at least 4 cycles of perioperative platinum/pemetrexed chemotherapy as per local practice. Less than 4 cycles of chemotherapy are allowed for clinical decisions - In patients previously treated with neoadjuvant chemotherapy, randomization should occur within 50 days from surgical resection. - In patients treated with adjuvant chemotherapy, randomization should occur within 30 ± 7 days from last dose of adjuvant treatment. • Performance status of 0-1 on the ECOG Performance Scale • Adequate organ function, all screening labs should be performed within 14 days of treatment initiation. • Availability of 1 tumor block at baseline.
排除标准
- •Patient with macroscopic residual disease after surgery • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll • Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy • Active infection requiring systemic therapy • History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab • Women with a positive pregnancy test at enrollment or prior to administration of study medication
结局指标
主要结局
DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first. DFS will be calculated based on disease status evaluated by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
次要结局
- -Incidence, nature, frequency, duration, timing and severity of serious adverse events (SAEs) and non-serious adverse events (AEs) related to atezolizumab treatment graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 5. -OS, defined as the time from start of study drug to the date of death from any cause. -EQ-5D-3L questionnaire
研究者
Scientific Responsible
Scientific
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
研究点 (14)
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