A randomised Phase II study comparing three vs six cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer (DISCUS)

Queen Mary University of London0 个研究点目标入组 224 人2022年3月10日

概览

暂无简介。

注册库

who.int

开始日期

2022年3月10日

结束日期

2026年10月31日

最后更新

2年前

研究类型

Interventional

性别

All

发起方

•1\. Willing and able to provide written informed consent
•2\. Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ\-C30 questionnaires
•3\. Age \=18 years
•4\. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required.
•5\. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) v1\.1
•6\. Eligible for gemcitabine/cisplatin or gemcitabine/carboplatin
•7\. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
•8\. Adequate haematologic and organ function
•9\. Negative serum or urine pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential only
•10\. Agreement to use adequate contraceptive measures

•1\. Prior treatment with a PD\-(L)\-1 inhibitor for any malignancy, including earlier stage UC
•2\. Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum\-containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since the last cycle have occurred.
•3\. Pregnant and lactating female patients
•4\. Known history of active CNS metastases
•5\. Prior allogeneic stem cell or solid organ transplantation
•6\. Oral or IV steroids for 14 days prior to C1D1
•7\. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study
•8\. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL]\-2\) within 4 weeks or five half\-lives of the drug, whichever is shorter, prior to enrolment
•9\. Concurrent treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment
•10\. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results,