A randomised phase II study comparing 3 vs 6 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2021年11月19日

适应症nresectable locally advanced or metastatic urothelial carcinoma MedDRA version: 20.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: nresectable locally advanced or metastatic urothelial carcinoma
发起方: Queen Mary University of London
入组人数: 224
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2021年11月19日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Queen Mary University of London

入排标准

入选标准

•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 RECIST v1\.1\.
•6\. Eligible for gemcitabine/ cisplatin or gemcitabine/carboplatin. The following criteria are established for the use of carboplatin (patients not fulfilling the following carboplatin criteria should be considered for gemcitabine/ cisplatin):
•a. GFR \<60 mL/min but \=30 mL/min (measured by the Cockcroft\-Gault formula. Subjects with a GFR \=50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin\-eligible based on the investigator’s clinical judgement.
•b. ECOG or WHO performance status of 2\.
•c. NCI CTCAE Grade \=2 audiometric hearing loss.
•d. NYHA Class III heart failure.

排除标准

•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 last cycle have occurred.
•3\. Pregnant and lactating female patients
•4\. Known history of active CNS metastases. Patients with treated CNS metastases are permitted on the study if all of the following are true:
•a. CNS metastases have been clinically stable for at least 4 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis
•b. the subject is on a stable dose of \=10 mg/day of prednisone or equivalent for at least 2 weeks prior to C1D1 (if requiring steroid treatment)
•c. subject does not have leptomeningeal disease
•5\. Prior allogeneic stem cell or solid organ transplantation
•6\. Oral or IV steroids for 14 days prior to C1D1\. The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e., for adrenal insufficiency), and mineralocorticoids (e.g., fludrocortisone) is allowed. Patients receiving treatment for CNS metastases at a stable dose of \=10 mg/day of prednisone or equivalent for at least 2 weeks prior to screening are eligible.
•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