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Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer (IMMUN VESSIE)

U

University Hospital of Bordeaux

Status

Completed

Conditions

Bladder Cancer

Treatments

Biological: Samples of bladder tissue

Study type

Observational

Funder types

Other

Identifiers

NCT04726735
CHUBX2018/55

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Patients with histologically documented normal bladder
Treatment:
Biological: Samples of bladder tissue
Patients with histologically documented Non Muscle Invasive Bladder Cancer
Treatment:
Biological: Samples of bladder tissue
Patients with histologically documented Muscle Invasive Bladder Cancer
Treatment:
Biological: Samples of bladder tissue

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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