Bladder Cancer
Conditions
Brief summary
The purpose of this study is to investigate the effect synchronous use of nivolumab in addition to chemoradiotherapy in patients withnon-metastatic MIBC who are not candidates for radical cystectomy
Detailed description
The initial hypothesis is that addition of nivolumab will increase 2-year locoregional control rate from 55% (control arm) to 75% (immunotherapy arm) There is a 24 month accrual period during which 78 patients will be randomized in a control group (standard chemo-radiotherapy) and the treatment group (chemo-radiotherapy + Nivolumab) The primary objective would be to compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy. The secondary objectives are 1. To study the safety of the addition of nivolumab to chemoradiotherapy in patients with MIBC 2. To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective) 3. To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy 4. Assess the effect of combined treatment on the quality of life Correlative studies of outcomes with PD-L1expression and with lymphocytic populations in the environment of the tumor
Interventions
BIOLOGICALNivolumab
standard of care chemoradiotherapy + Nivolumab
OTHERchemoradiotherapy
standard of care chemoradiotherapy
Sponsors
Hellenic GenitoUrinary Cancer Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven, muscle-invasive carcinoma of the bladder, cT2-T4aN0M0 * Urothelial, squamous or glandular histology according to WHO 2016 classification (Fig 1) * Undergone a vigorous TURB * Not candidates for radical cystectomy. * PS:0-1 * age \>18 years old * Adequate bone marrow function * Adequate renal function
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional control rate | 2 years | To compare locoregional control rate at 2-years between patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of treatment-related adverse event (safety and tolerability) | 2 years | Incidence of adverse events as assessed by CTCAE. After radiotherapy completion, AEs will be assessed according to RTOG/EORTC Late Radiation Morbidity Scoring Schema |
| Bladder cancer failure-free (BCFF) rates | 2 years | To compare 2-year bladder cancer failure-free (BCFF) rates, defined as distant metastasis free survival (MFS) AND/OR locoregional failure (defined as in primary objective) |
| Median overall survival (OS) | 2 years | To compare median overall survival (OS) in patients with MIBC receiving or not receiving nivolumab in addition to chemoradiotherapy |
| Assessment of the effect of the combined treatment on the quality of life | 2 years | Quality of life score assessed by Quality of Life of Cancer Patients Questionnaire (EORTC QLQ-C30). Discomfort measured in a scale from 1 (not at all) to 4 (very much) Overall health and quality of life score measured in a scale from 1 (very poor) to 7 (excellent) |
Countries
Greece
Contacts
Primary ContactVasiliki Magoula, MSc
Outcome results
None listed