EUCTR2015-003262-86-GB进行中（未招募）1 期
A PHASE 3, MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE AS A MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CANCER WHOSE DISEASE DID NOT PROGRESS AFTER COMPLETION OF FIRST-LINE PLATINUM-CONTAINING CHEMOTHERAPY - JAVELIN Bladder 100
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 668
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Histological diagnosis of confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium. Patients with documented Stage IV disease (per American Joint Committee on cancer/International Union for Cancer Control Tumor Node Metastasis (TNM) system 7th edition) at the start of first-line chemotherapy and measurable disease prior to the start of first-line chemotherapy by RECIST v1.1.
- •2. Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin. No other chemotherapy regimens are allowed in this study. The last dose of first-line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization;
- •3. Patients without progressive disease as per RECIST v1.1 guidelines (ie, with an ongoing CR, PR, or SD) following completion of 4 to 6 cycles of first-line chemotherapy. Eligibility based on this criterion will be determined by investigator review of pre-chemotherapy and postchemotherapy radiological assessments (CT/MRI scans);
- •4.Provision of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (subsection thereof) from the most recent primary or metastatic tumor biopsy or resection obtained prior to treatment with first line chemotherapy but within 24 months prior to randomization, with no intervening systemic anti-cancer therapy. If a FFPE tissue block cannot be provided, 15 freshly cut unstained slides (10 minimum) will be
- •acceptable. Tumor tissue from cytologic sampling (eg, fine needle aspiration, including FFPE cell pellet material) or bone metastases are not acceptable and should not be submitted;
- •5. Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative, as allowed by local guideline/practice) has been informed of all pertinent aspects of the study,
- •6. Patients who are willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;
- •7. Age above 18 years;
- •8. Estimated life expectancy of at least 3 months;
- •9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
- •10. Adequate bone marrow, renal and liver function;
- •11. Negative serum pregnancy test at screening (for females of childbearing potential);
- •12. Female patients able to have children must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 481
排除标准
- •1. Patients whose disease progressed by RECIST v1.1 on or after first-line chemotherapy for urothelial cancer;
- •2. Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization;
- •3. Prior immunotherapy with IL-2, IFN-a, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways;
- •4. Major surgery within 4 weeks or major radiation therapy within 2 weeks prior to randomization. Prior palliative radiotherapy is permitted, provided it has been completed at least 48 hours prior to patient randomization;
- •5. Patients with known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable;
- •6. Persisting toxicity related to prior therapy NCI CTCAE v4.0 Grade >1; however, alopecia, sensory neuropathy Grade <= 2 is acceptable, or other Grade <=2 adverse eventsnot constituting a safety risk based on the investigator's judgment are acceptable;
- •7. Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or lowgrade (Gleason 6 or below) prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration), or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms;
- •8. Participation in other studies involving investigational drug(s) within 4 weeks prior to randomization. Observational studies are permitted;
- •9. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible;
- •10. Clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure, or serious cardiac arrhythmia requiring medication;
- •11. Active infection requiring systemic therapy;
- •12. Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3), any history of anaphylaxis, or uncontrolled asthma;
- •13. Known prior or suspected hypersensitivity to study drugs or any component in their formulations;
- •14. Current or prior use of immunosuppressive medication within 7 days prior to randomization;
- •15. Diagnosis of prior immunodeficiency or organ transplant requiring
- •immunosuppressive therapy;
- •16. Positive test for human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
- •17. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening;
- •18. Vaccination
研究者
相似试验
进行中（未招募）
1 期
A Study of Avelumab in Patients with Bladder Cancer that did Not Worsen Following Completion of First-Line ChemotherapyEUCTR2015-003262-86-CZPfizer Inc, 235 East 42nd Street, New York, NY 10017668
进行中（未招募）
1 期
A Study of Avelumab in Patients with Bladder Cancer that did Not Worsen Following Completion of First-Line Chemotherapyocally advanced or metastatic urothelial cancerMedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864EUCTR2015-003262-86-FRPfizer Inc, 235 East 42nd Street, New York, NY 10017668
进行中（未招募）
1 期
A Study of Avelumab in Patients with Bladder Cancer that did Not Worsen Following Completion of First-Line ChemotherapyEUCTR2015-003262-86-NLPfizer Inc, 235 East 42nd Street, New York, NY 10017668
进行中（未招募）
1 期
A Study of Avelumab in Patients with Bladder Cancer that did Not Worsen Following Completion of First-Line Chemotherapyocally advanced or metastatic urothelial cancerMedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864EUCTR2015-003262-86-ITPfizer Inc, 235 East 42nd Street, New York, NY 10017668
进行中（未招募）
1 期
A Study of Avelumab in Patients with Bladder Cancer that did Not Worsen Following Completion of First-Line Chemotherapyocally advanced or metastatic urothelial cancerMedDRA version: 19.0Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864EUCTR2015-003262-86-GRPfizer Inc, 235 East 42nd Street, New York, NY 10017668