Safety and Efficacy of Neoadjuvant immunotherapy with Durvalumab (MEDI 4736) in combination with neoadjuvant chemotherapy (Gemcitabin/Cisplatin or Gemcitabin/Carboplatin) in patients with operable, high-risk, localized urothelial carcinoma of the upper urinary tract. iNDUCT - GETUG V08
Key facts
- Where
- Nîmes, FranciaországSee the site
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire de NîmesNîmes, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Nimes
- Trial code
- EU 2024-516077-72-02
- Record updated
- 2024. november 28.
- Original description
To assess in each cohort and independently the pathological complete response (ypT0) rate of a combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin or Carboplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinoma of the upper tract.Read full original descriptionShow less
To assess in each cohort and independently the pathological complete response (ypT0) rate of a combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin or Carboplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinoma of the upper tract.
Inclusion: 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; Presence of either: o High-grade disease on ureteroscopic tumor biopsy OR o High-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 In 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; 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; Body weight > 30 Kg; No prior systemic therapies; Patient must be eligible to radical nephroureterectomy surgery; ECOG performance status 0 to 1; M0 No or N1 disease on CT scan.
Exclusion: Concomitant diagnosis of muscle invasive or in situ or high grade non muscle invasive urothelial carcinoma of the bladder; Concomitant use of any other investigational drugs; Diagnosis of immunodeficiency or received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration; Evidence of NYHA functional class III or IV heart disease; Serious intercurrent medical or psychiatric illness, including serious active infection; 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; History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).