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

CHU DE NIMES0 sites99 target enrollmentSeptember 11, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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.
Sponsor: CHU DE NIMES
Enrollment: 99
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

September 11, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

CHU DE NIMES

•The patient has been correctly informed.
•The patient must have given his/her informed and signed consent.
•The patient must be insured or beneficiary of a health insurance plan.
•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.
•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:
•oHigh\-grade disease on ureteroscopic tumor biopsy OR
•oHigh\-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.
•No prior systemic therapies.

•The patient is participating in another interventional trial;
•\-or is in an exclusion period determined by a previous study;
•\-or is under judicial protection, or is an adult under guardianship;
•\-or refuses to sign the consent;
•\-or it is impossible to correctly inform the patient.
•The patient is pregnant or breastfeeding.
•Concomitant diagnosis of muscle invasive or in situ or high grade non muscle invasive urothelial carcinoma of the bladder.
•Evidence of NYHA functional class III or IV heart disease.
•Serious intercurrent medical or psychiatric illness, including serious active infection.
•Concomitant use of any other investigational drugs.