NCT06421311终止不适用
Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2024年7月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS) of participants
研究概览
简要总结
This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%:
- •Who received neoadjuvant chemotherapy OR
- •Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy
- •At least 18 years of age at the time of treatment decision
- •Decision to treat with adjuvant nivolumab therapy has already been taken
- •Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively)
排除标准
- •Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
- •Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities).
- •Pregnant women
- •Participants under guardianship
研究组 & 干预措施
Participants with muscle invasive urothelial carcinoma receiving nivolumab
干预措施: nivolumab (Drug)
结局指标
主要结局
Disease-free survival (DFS) of participants
时间窗: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
次要结局
- Dose adjuvant nivolumab per cycle(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Reason for adjuvant nivolumab treatment discontinuation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Time to recurrence (TRR)(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Non-urothelial tract recurrence free survival (NUTRFS)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Distance metastases-free survival (DMFS)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Participant comorbidities pre-existing at the time of adjuvant therapy initiation(Index date)
- Participant renal function at treatment initiation(Day 1)
- Number of adjuvant nivolumab treatment cycles(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Reason for adjuvant nivolumab treatment interruption(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Overall survival (OS)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Participant baseline clinical characteristics(Baseline)
- Participant concomitant systemic treatment(s)(Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Participant muscle Invasive urothelial carcinoma disease characteristics(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Adjuvant nivolumab treatment duration(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Locoregional disease free survival (LRFDS)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Second progression-free survival (PFS2)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Participant demographics(Baseline)
- Systemic neoadjuvant treatment history(Baseline)
- Participant history of previous urothelial carcinoma(Baseline)
- PD-L1 status testing results(Baseline)
- Time from radical surgery to adjuvant nivolumab treatment initiation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Participant adverse events(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Disease specific survival (DSS)(At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60)
- Surgery for muscle-invasive urothelial carcinoma(Baseline)
- Delay in adjuvant nivolumab treatment initiation related to post-operative complications(Baseline)
- Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire(Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36)
- Participant history of other cancer(s(Baseline)
- Diagnosis of muscle-invasive urothelial carcinoma diagnosis(Baseline)
- Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Non-systemic treatments prescribed post adjuvant nivolumab discontinuation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
- Systemic treatment prescribed post adjuvant nivolumab discontinuation(At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60)
研究者
研究点 (1)
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