CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 50 target
Drug / intervention
Patients receiving neoadjuvant therapy before radical nephrectomydrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓High-grade urothelial carcinoma of renal pelvis or ureter confirmed histologically or cytologically
  • ✓Presence of high-grade disease on uteroscopic biopsy OR high-grade on cytology with infiltrative wall/hydronephrosis on CT and negative cystoscopy
  • ✓Patients over 70 must have G8 score of at least 14
  • ✓Body weight over 30kg
Key exclusion· 15
  • ✕Pregnant or breastfeeding
  • ✕Concomitant muscle invasive, in situ, or high-grade non-muscle invasive bladder urothelial carcinoma
  • ✕NYHA functional class III or IV heart disease
  • ✕Serious intercurrent medical or psychiatric illness, including serious active infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04617756
NCT04617756Phase 2RecruitingUpdate OverdueUpdated 37mo ago · Completion was 17mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Safety & Efficacy of Neoadjuvant Immunotherapy With Durvalumab (MEDI 4736) Combined With Neoadjuvant Chemotherapy (Gemcitabine/Cisplatin or Gemcitabine/Carboplatin) in Patients With Operable, High-risk, Localized Urothelial Carcinoma of the Upper Urinary Tract

Centre Hospitalier Universitaire de Nīmes·interventional·Posted Nov 5, 2020·Updated May 30, 2023

In Brief

A Phase 2 clinical trial evaluating Patients receiving neoadjuvant therapy before radical nephrectomy for Urothelial Carcinoma and Cancer. Currently recruiting, targeting 50 participants across 9 sites.

Signals

Enrollment appears stalled

Detailed Summary

Following radical nephrectomy (RNU) for upper tract urothelial carcinoma (UTUC) most patients face a poor prognosis. Indeed, patients who have undergone RNU for UTUC have 5-year recurrence-free and cancer specific survival probabilities of 69% and 73% respectively. The primary objective of this study is to assess the pathological complete response rate to combination therapy with neoadjuvant durvalumab and chemotherapy (Gemcitabine/Cisplatin) before surgery in patients with high-risk, localized, non-metastatic urothelial carcinomas of the upper tract.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma, Cancer
CountriesFrance
CollaboratorsPitié-Salpêtrière Hospital, Bichat Hospital, Hopital Foch 92151 Suresnes, Institut Paoli-Calmettes, European Georges Pompidou Hospital, Saint-Louis Hospital, Paris, France, Centre Hospitalier Lyon Sud, Center Eugene Marquis, IUCT ONCOPOLE

Timeline

Phase 2Recruiting
202120222023202420252026
First PostedNov 5, 2020
Enrollment StartSep 29, 2021
Primary CompletionJan 1, 2025
Study CompletionOct 1, 2026
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.7 years ago

Interventions

Patients receiving neoadjuvant therapy before radical nephrectomydrug

Chemotherapy using either a combination of Gemcitabine/Cisplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736) or Chemotherapy with either Gemcitibine/Carboplatin and neoadjuvant immunotherapy therapy with Durvalumab (MEDI 4736)