ISRCTN15750433进行中（未招募）2 期
A randomised Phase II study comparing three vs six cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer (DISCUS)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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 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
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 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,
- •11. Malignancies other than urothelial carcinoma of the bladder within 3 years prior to Cycle 1, Day 1
- •12. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebral vascular accident/stroke within 6 months prior to enrolment, unstable arrhythmias, or unstable angina
- •13. Radiotherapy within 2 weeks prior to C1D1
- •14. Major surgery (defined as requiring general anaesthesia and >24-hour inpatient hospitalization) within 4 weeks prior to randomisation. Patients must have recovered adequately from complications from the intervention prior to starting study treatment.
- •15. History of idiopathic pulmonary fibrosis (including pneumonitis),drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted)
- •16. Active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.
- •17. Positive HIV test
- •18. Active tuberculosis
- •19. History of autoimmune disease
- •21. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies
- •22. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of avelumab
- •23. Active infection requiring systemic therapy
- •24. Persisting toxicity related to prior therapy
- •25. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient
研究者
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