Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France

Launched by BRISTOL-MYERS SQUIBB · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called nivolumab for patients with muscle invasive urothelial carcinoma (MIUC), a type of bladder cancer that has a high chance of coming back after surgery. The researchers want to see how well this treatment works in real-life situations in France, specifically for adults who have already made the decision to use nivolumab after their surgery. The study is currently looking for participants aged 18 and older who have been diagnosed with MIUC and have certain characteristics, like having a specific level of a protein called PD-L1 in their tumor.

To be eligible, participants should have had their cancer surgically removed and either received chemotherapy before surgery or are not able to take another type of chemotherapy called cisplatin. Those who are pregnant, currently have another type of cancer, or are part of a different clinical trial cannot join this study. If you participate, you can expect to be monitored for your health and any effects of the treatment over time. This study is a way to gather more information about how well nivolumab works for patients like you in everyday practice, helping doctors make better treatment decisions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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)
• Exclusion Criteria:
• • 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

Trial Officials