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

Bristol-Myers Squibb (BMS)

Status: Terminated

Conditions: Urothelial Carcinoma

Treatments: Drug: nivolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06421311

CA209-1416

Details and patient eligibility

About

This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

176 participants in 1 patient group

Participants with muscle invasive urothelial carcinoma receiving nivolumab

Treatment:

Drug: nivolumab