EUCTR2017-004634-28-ES进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN CISPLATIN-INELIGIBLE PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY (MORPHEUS-mUC)
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
- 305
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
- •- Age >=18 years
- •- Life expectancy >= 3 months, as determined by the investigator
- •- Ineligible for cisplatin-based chemotherapy
- •- Histologically documented, locally advanced or metastatic UC (M1, Stage IV)
- •- No prior chemotherapy for inoperable, loally advanced or metastatic UC
- •- Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1 (PD-L1) and/or additional biomarker status by means of central testing
- •- Disease progression during or following treatment with no more than one platinum containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
- •Stage 1 and Stage 2
- •- Ability to comply with the study protocol, in the investigator’s judgment
- •- Eastern Cooperative ncology Group Performance Status of 0 or 1
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST) v1.1
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen during the 14 days prior to initiation of study treatment
- •- Negative HIV test at screening
- •- Negative total hepatitis B core antibody (HBcAb) test or positive total HBcAb test followed by quantitative hepatitis B virus (HBV) DNA < 500 IU/mL at screening and Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- Tumor accessible for biopsy
- •- For women and men of childbearing potential: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
- •- Patients in the atezolizumab control arm: ability to initiate Stage 2 treatment within 3 months after loss of clinical benefit as determined by the investigator while receiving control treatment
- •- Patients in an experimental arm during Stage 1: ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity not related to atezolizumab or loss of clinical benefit as determined by the investigator while receiving Stage 1 treatment
- •- Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 213
排除标准
- •- Prior treatment with a T-cell co-stimulating therapy or an immune checkpoint inhibitor including anti- CTLA-4 anti-PD-1, and anti-PD-L1 therapeutic antibodies
- •- Prior treatment with any of the protocol-specified study treatments including treatment with any poly polymerase inhibitor, nectin-4 targeting agents, signal regulatory protein a-targeting agents, or agents that block CD38
- •- Any approved anti-cancer therapy
- •- Eligible only for the control arm
- •Stage 1 and Stage 2
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug prior to the initiation of study treatment
- •- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures and tumor-related pain
- •- Uncontrolled or symptomatic hypercalcemia and symptomatic, untreated or actively progressing central nervous system metastases
- •- History of leptomeningeal disease, autoimmune disease, idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- •- History of malignancy other than UC within 2 years prior to screening
- •- Active tuberculosis (TB)
- •- Severe infection within 4 weeks prior to initiation of study treatment
- •- Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment
- •- Significant cardiovascular disease
- •- Grade >=3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- •- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •- Adverse events from prior anti-cancer therapy that have not improved to Grade <=1 or better, with the exception of alopecia of any grade and Grade <=2 peripheral neuropathy
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug
- •- History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins
- •- Known intolerance or hypersensitivity to any of the study drugs or their excipients and any of the drugs required for premedication
- •- Patients entering Stage 2: inability to tolerate atezolizumab during Stage 1
- •- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- •- Patients entering Stage 2: recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent
- •For Atezo-EV Arm during Stage 1 and Stage 2
- •- Ongoing sensory or motor neuropathy Grade >= 2
- •- Active keratitis or corneal ulcer
研究者
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