Durvalumab for Urothelial carcinoma of the upper urinary tract | Urothelial carcinoma

Inclusion criteria

• {"criterion_text":"- The patient has a histologically-confirmed (ureteroscopic biopsy) or cytologically(urine cytology)-confirmed diagnosis of high-grade urothelial carcinoma of the renal pelvis or ureter. Presence of divergent histologies (i.e. squamous-cell tumor, adenocarcinoma, small cell carcinoma, micropapillary variant) may be acceptable provided that there is an important prevalence (> 90%) of urothelial component.\n- Presence of either: o\tHigh-grade disease on ureteroscopic tumor biopsy OR o\tHigh-grade disease on urine cytology AND infiltrative aspect of renal pelvis/ureteral wall on CT imaging (presence of hydronephrosis will be considered invasive by definition) with negative cystoscopy. o\tIn the absence of histological evidence, the opinion of the multidisciplinary consultation meeting (RCP) will prevail for the analysis of the imaging and the potential inclusion of the patient in the study\n- The patient is at least 18 years old. Patients older than 70 years will be evaluated for fragility with G8 score (Soubeyran et al. 2014). Patients with a G8 score of less than 14 will not be included in the study.\n- Body weight > 30 Kg.\n- No prior systemic therapies.\n- Patient must be eligible to radical nephroureterectomy surgery\n- ECOG performance status 0 to 1.\n- M0 No or N1 disease on CT scan."}

Exclusion criteria

• {"criterion_text":"- Concomitant diagnosis of muscle invasive or in situ or high grade non muscle invasive urothelial carcinoma of the bladder.\n- Evidence of NYHA functional class III or IV heart disease.\n- Serious intercurrent medical or psychiatric illness, including serious active infection.\n- Concomitant use of any other investigational drugs.\n- Diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.\n- Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.\n- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)."}

Primary endpoints

• {"endpoint_text":"- In each cohort and independently the rate of patients who achieved a pathological complete response (PCR) after surgery will be assessed. Pathological complete response (PCR) is defined as no residual signs of viable tumor cells in tissue samples removed during surgery after treatment (yPT0). To find out if there is a pathologic complete response, a pathologist will perform an evaluation of the tissue samples under a microscope to see if there are still cancer cells left after the treatment.","definition_or_measurement_approach":"Pathological complete response (PCR) is defined as no residual signs of viable tumor cells in tissue samples removed during surgery after treatment (yPT0). Determination is by pathologist microscopic evaluation of tissue samples removed during surgery."}

Secondary endpoints

• {"endpoint_text":"- In each cohort and independently: Rate of patients showing pathological partial response (PaR). PaR is defined as downstaging to neoadjuvant pathologic stage groups ≤ ypT1N0M0 (ypT0-Ta-Tis/T1 disease). The rate of patients with PaR will be calculated on the subpopulation of patients with ureteroscopic biopsy at diagnosis.\n- In each cohort and independently: Assessment of safety and tolerability by analysing and interpreting Common Terminology Criteria for Adverse Event (CTCAE) until surgery using the National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) listing of CTCAE (NCI CTCAE V5.0).\n- In each cohort and independently:The overall survival, bladder recurrence, dissemination will be collected at 2 years follow-up after surgery.","definition_or_measurement_approach":"PaR defined as downstaging to ≤ ypT1N0M0 (ypT0-Ta-Tis/T1); calculated on patients with ureteroscopic biopsy at diagnosis. Safety/tolerability assessed using NCI CTCAE V5.0 until surgery. Overall survival, bladder recurrence and dissemination collected at 2 years post-surgery."}

France

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

28-11-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nimes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France