Treatment to modulate the activity of the immune system in combination with chemotherapy treatment in patients with operable urothelial cancer
- Conditions
- muscle invasive urothelial cancer (MIUC)MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003565-10-DE
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 61
- histologically proven urothelial cell carcinoma of the bladder, urethra or upper urinary tract and considered suitable for curative multimodality treatment including surgery by a multidisciplinary tumor board
- all histological subtypes eligible if urothelial carcinoma predominant
- WHO performance Status 0-1
- adequate bone marrow, hepatic, renal and cardiac function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
- pathological evidence of small-cell carcinoma component
- presence of distant metastasis
- previous Treatment with a PD-1 or PD-L1 Inhibitor, including durvalumab
- current or prior use of immunosuppressiva medication within 28 days prior to Registration
- active or prior documented autoimmune or inflammatory disorders
- known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B virus infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to demonstrate that the addition of neoadjuvant and adjuvant immunotherapy with durvalumab to standard neoadjuvant chemotherapy (with cisplatin/gemcitabine) and surgery in urothelial carcinoma could improve event-free survival. ;Secondary Objective: not applicable;Primary end point(s): Primary endpoint of the trial is event-free survival (EFS) at two years after trial treatment start (neoadjuvant). EFS is defined as the time from treatment start until one of the following events, whichever comes first:<br>- progression during neoadjuvant treatment is leading to inoperability<br>- recurrence of locoregional disease after surgery<br>- appearance of metastases at any localization<br>- death;Timepoint(s) of evaluation of this end point: two years after treatment start
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Event free survival (EFS)<br>- recurrence-free survival (RFS) after R0 resection<br>- Overall survival (OS)<br>- Quality of resection<br>- Pathological complete response rate (ypT0)<br>- Pathological response rate (PaR) defined by pathological downstaging to =ypT1N0M0<br>- Pattern of recurrence<br>- Treatment feasibility<br>- Adverse events;Timepoint(s) of evaluation of this end point: at every study visit