Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
NCT ID: NCT04726735
Last Updated: 2021-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
100 participants
OBSERVATIONAL
2020-03-16
2020-05-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
NCT04387461
Pembrolizumab and BCG Solution in Treating Patients With Recurrent Non-Muscle-Invasive Bladder Cancer
NCT02808143
Pembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)]
NCT03504163
Intravesical Ty21a for the Treatment of Patients With Non-muscle-invasive Bladder Cancer (NMIBC)
NCT03421236
URO-BCG-4 : Bladder Tumors Immunotherapy
NCT00213655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with histologically documented normal bladder
Samples of bladder tissue
Samples of bladder tissue collected between 2007 and 2011.
Patients with histologically documented Non Muscle Invasive Bladder Cancer
Samples of bladder tissue
Samples of bladder tissue collected between 2007 and 2011.
Patients with histologically documented Muscle Invasive Bladder Cancer
Samples of bladder tissue
Samples of bladder tissue collected between 2007 and 2011.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Samples of bladder tissue
Samples of bladder tissue collected between 2007 and 2011.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Samples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.
Exclusion Criteria
* Active tuberculosis
* Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Bordeaux
OTHER
University Hospital, Bordeaux
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Universitaire de Bordeaux
Talence, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUBX2018/55
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.