Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy

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追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 15, 2018

预计主要完成日期

January 15, 2022 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Disease Free Survival[ Time Frame: 2 years ]

Disease Free Survival is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Local control rate[ Time Frame: 2 years ]
Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.
Local control rate[ Time Frame: 5 years ]
Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.
Disease Free Survival[ Time Frame: 5 years ]
Disease Free Survival is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.
Overall Survival[ Time Frame: 2 years ]
Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.
Overall Survival[ Time Frame: 5 years ]
Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.
Incidence of Treatment-Emergent Adverse Events[ Time Frame: 2 years ]
The tolerance and safety will be evaluated by toxicity (acute [<6 months after the start of atezolizumab] and late [≥6 months after the start of atezolizumab]), assessed using the NCI CTCAE v5.0
Incidence of Treatment-Emergent Adverse Events[ Time Frame: 5 years ]
The tolerance and safety will be evaluated by toxicity (acute [<6 months after the start of atezolizumab] and late [≥6 months after the start of atezolizumab]), assessed using the NCI CTCAE v5.0
Quality of Life Core Questionnaire - Cancer Patients (QLQ-C30)[ Time Frame: 5 years ]
Quality of life
Quality of Life Core Questionnaire - Bladder Cancer Muscle Invasive (QLQ-BLM30)[ Time Frame: 5 years ]
Quality of Life
Quality of Life Core Questionnaire - Ederly Cancer Patients (QLQ-ELD14)[ Time Frame: 5 years ]
Quality of Life
G8 oncodage[ Time Frame: 5 years ]
Quality of Life

描述性信息

简略标题 ^ICMJE

Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy

正式标题 ^ICMJE

Phase II Study of Maintenance Anti-PD-L1 Treatment With Atezolizumab After Chemo-radiotherapy for Muscle-infiltrating Bladder Cancer Patients Not Eligible for Radical Cystectomy: Bladder Sparing

简要概况

Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal. This study is designed as a multicentre, single-arm phase II study.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Atezolizumab
Atezolizumab after adjuvant radio-chemotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy

研究工具

Experimental: atezolizumab
Anti-PD-L1 immunotherapy: atezolizumab (1200 mg) administered IV over 1 h every 3 weeks for 12 months (18 injections). Beginning 30 days (±5 days) after chemo-radiotherapy.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 15, 2025

预计主要完成日期

January 15, 2022 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Selection phase Inclusion Criteria: 1. Muscle-invasive bladder cancer (MIBC) pT2-T3 histologically confirmed: Urothelial and squamous cell histological types are allowed. De novo MIBC or after a history of non-muscle-invasive bladder cancer. 2. Complete transurethral resection of bladder tumour (TURBT), either: within 6 weeks of selection if no chemotherapy was administered, or before starting chemotherapy. 3. Patients for which chemo-radiotherapy is planned 4. No major pelvic involvement: pelvic nodes ≤15 mm on CT scan. 5. No distant metastasis. 6. Patient unfit for radical cystectomy because of age, comorbidities, or patient's refusal. 7. Patients ≥18 years old 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 9. Life expectancy ≥12 months. 10. Haematological and biological parameters: White blood cell count ≥4000/mm3 Platelet count ≥100000 cells/mm3 Haemoglobin level ≥9 g/dL or corrected after transfusion A glomerular filtration rate ≥25 mL/min. Adequate renal function: clearance >50 mL/min (MDRD). Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x upper limit of normal (ULN), or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible. 11. Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to selection. 12. Patients having provided written informed consent prior to any study-related procedures. 13. Patients affiliated to the social security scheme. 14. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. 15. Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection. Exclusion Criteria: 1. Prior pelvic irradiation. 2. MIBC histology other than urothelial or squamous cell carcinomas (e.g., adenocarcinomas, micropapillary, sarcomas, or small cell histological types). 3. History of neoplastic disease, during the 3 years before selection, except completely resected cutaneous basal-cell carcinomas, carcinoma in-situ or localised prostate cancer without biochemical recurrence following definitive treatment. 4. Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies. 5. Contraindications for pelvic radiotherapy (e.g., inflammatory bowel disease). 6. History of immunodeficiency, including HIV infection, or systemic steroid therapy for any other disease. 7. A history of active autoimmune disease, except autoimmune-related hypothyroidism and type I diabetes mellitus (see appendix 5). 8. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins. 9. Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation. 10. Prior allogeneic stem cell or solid organ transplant. 11. Patients with the following severe acute co-morbidity are not eligible: Unstable angina or congestive heart failure that required hospitalisation in the 6 months before selection. Transmural myocardial infarction in the 6 months prior to selection. Acute bacterial or fungal infection requiring intravenous antibiotics at selection. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalisation or precluding study therapy at the time of selection. Severe hepatic disease: Child-Pugh Class B or C. 12. Patients with any other disease or illness which requires hospitalisation or is incompatible with the study treatment are not eligible. 13. Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study. 14. Patients enrolled in another therapeutic study within 30 days of selection. 15. Pregnant or breast feeding women. 16. Person deprived of their liberty or under protective custody or guardianship. Inclusion phase Inclusion Criteria: 1. Patients who have received standard (chemo)-radiotherapy ≥60 gray (Gy) or equivalent on the bladder according to the local practice. 2. The first administration of atezolizumab must be performed 30 (+/-5) days after the last session of radiotherapy (RT). 3. ECOG performance status ≤2. 4. Haematological and biological parameters: White blood cell count ≥4000/mm3 Platelet count ≥100000 cells/mm3 Haemoglobin level ≥9 g/dL or corrected after transfusion A glomerular filtration rate ≥25 mL/min Adequate renal function: clearance >50 mL/min (MDRD) Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible. 5. Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to inclusion. 6. Patients having provided written informed consent prior to any study-related procedures. 7. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol. 8. Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection. Exclusion Criteria: The same non-inclusion criteria of the selection phase have to be respected.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：100 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

France

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

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研究赞助商 ^ICMJE

UNICANCER

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验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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