Clinical trial NCT04726735: Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
Official title: Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Non Muscle Invasive Bladder Cancer
Bacillus Calmette-Guerin
Programmed cell Death-Ligand protein 1
Programmed cell Death 1
Muscle Invasive Bladder Cancer
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
First posted: 2021-01-27
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.

Brief summary: Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).

The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.

Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.

The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.

The secondary objective is to characterize the immune contexture of NMIBC.

Detailed description: Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).

The local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.

Systemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.

The aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.

The secondary objective is to characterize the immune contexture of NMIBC. The immunological contexture of NMIBC in comparison with normal bladder tissue and invasive bladder cancer will be deciphered. The objective is to determine immune signatures associated with response or relapse/progression, with and without immune treatments in NMIBC.

Eligibility criteria: Inclusion Criteria:

Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.

Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.

Exclusion Criteria:

* History of autoimmune disease
* Active tuberculosis
* Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Primary outcomes:
measure: PD-L1 status (positive or negative) of the tumor and tumor associated immune cells.
timeFrame: Day 1
Secondary outcomes:
measure: Descriptive analysis of the differential expression of all the following immune biomarkers in normal bladder tissue, NMIBC (Non Muscle Invasive Bladder Cancer) and MIBC (Muscle Invasive Bladder Cancer).
timeFrame: Day 1
measure: Association of immune profile with recurrence and progression rates
timeFrame: Day 1
Other outcomes:
Locations:
city: Talence
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References: