NL-OMON55699已完成3 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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
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 recieved 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 post-chemotherapy 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 monthsof 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 sumbitted;,
- •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
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-*, 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 (<= 10 fractions) to metastatic
- •lesion(s) 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 <= adverse events not
- •constituting a sefetey risk based on the investigator's judgement 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 low-grade
- •(Gleason 6 or below) prostate cancer on surveillance without any plans for
- •treatment intervention (eg, surgery, radiation, or castration), or prostate
- •cancer that had been adequatley treated with prostatectomy or radiotherapy and
- •currentley 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 enrolment), myocardial infarction (<6months
- •prior to enrolment), 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 know acquired immunodeficiency
- •syndrome (AIDS)
- •17. Hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening;, 18.
- •Vaccination within 4 weeks of the first dose of study treatment and while on
- •trial is prohibited ex
研究者
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