NCT05645692进行中（未招募）2 期
A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 84
- 主要终点
- Incidence and Severity of Adverse Events
研究概览
简要总结
This study will evaluate the safety of tobemstomig alone or in combination with tiragolumab compared with atezolizumab in participants with previously untreated, locally advanced or metastatic urothelial cancer (mUC) who are ineligible to receive a platinum containing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- •Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Participants with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Participants with other variant histologies or pure variant histologies are not eligible for inclusion in this study
- •Ineligible ("unfit") to receive platinum-based chemotherapy
- •No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)
- •Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)
- •Availability of a representative leftover tumor specimen that is suitable for determination of PD-L1 status as assessed by a central laboratory
- •Adequate hematologic and end organ function
- •Negative for hepatitis B and hepatitis C virus (HCV)
- •Adequate cardiovascular function
排除标准
- •Pregnancy or breastfeeding
- •GFR <15 mL/min/1.73 m2
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled or symptomatic hypercalcemia
- •Active or history of autoimmune disease or immune deficiency
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •Active tuberculosis (TB) or acute Epstein-Barr virus (EBV)
- •Significant cardiovascular/cerebrovascular disease within 3 months 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
- •History of another primary malignancy other than urothelial carcinoma within 2 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death
- •Severe infection within 4 weeks prior to initiation of study treatment
- •Treatment with therapeutic oral or intravenous antibiotics within 2 weeks prior to initiation of study treatment. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease [COPD] exacerbation), or who are receiving oral antibiotics to treat a urinary tract infection are eligible for the study
- •Prior allogeneic stem cell or solid organ transplantation
- •Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of tobemstomig, or 90 days after the final dose of tiragolumab
- •Current treatment with anti-viral therapy for HBV
- •Treatment with any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
- •Treatment with investigational therapy within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-TIGIT and anti-LAG3 therapeutic antibodies or pathways targeting agents
- •Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives prior to initiation of study treatment
- •Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
- •History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
研究组 & 干预措施
Arm B
Experimental
Participants will receive IV tobemstomig Q3W.
干预措施: Tobemstomig (Drug)
Arm C
Experimental
Participants will receive IV tobemstomig + IV tiragolumab Q3W.
干预措施: Tiragolumab (Drug)
Arm A
Active Comparator
Participants will receive intravenous (IV) atezolizumab every 3 weeks (Q3W).
干预措施: Atezolizumab (Drug)
Arm C
Experimental
Participants will receive IV tobemstomig + IV tiragolumab Q3W.
干预措施: Tobemstomig (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events
时间窗: Up to approximately 30 months
次要结局
- Progression-Free Survival (PFS)(Up to approximately 30 months)
- Overall Survival (OS)(Up to approximately 30 months)
- Duration of Response (DOR)(Up to approximately 30 months)
- PFS(6 months and 12 months)
- OS(6 months, 12 months, and 18 months)
- Disease Control Rate (DCR)(Up to 12 weeks)
- Time to Confirmed Deterioration (TTCD)(Baseline up to 3 weeks)
- Change from Baseline in European Organisation for Research and Cancer Treatment Item Library 187 (EORTC IL 187) Scores(Up to approximately 30 months)
- Maximum Concentration (Cmax) of Tobemstomig(Up to approximately 30 months)
- Time of Maximum Concentration (Tmax) of Tobemstomig(Up to approximately 30 months)
- Clearance (CL) of Tobemstomig(Up to approximately 30 months)
- Volume of Distribution at Steady State (Vss) of Tobemstomig(Up to approximately 30 months)
- Area Under the Curve (AUC) of Tobemstomig(Up to approximately 30 months)
- Half-Life (T1/2) of Tobemstomig(Up to approximately 30 months)
- Maximum serum concentration (Cmax) of tiragolumab(Up to approximately 30 months)
- Minimum serum concentration (Cmin) of tiragolumab(Up to approximately 30 months)
- Cmax of atezolizumab(Up to approximately 30 months)
- Cmin of atezolizumab(Up to approximately 30 months)
- Incidence of Anti-Drug Antibodies (ADAs)(Up to approximately 30 months)
研究者
研究点 (84)
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