Clinical trial · Observational
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Samples of bladder tissue | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Patients with histologically documented normal bladder
- interventionNames
- Biological: Samples of bladder tissue
- label
- Patients with histologically documented Non Muscle Invasive Bladder Cancer
- interventionNames
- Biological: Samples of bladder tissue
- label
- Patients with histologically documented Muscle Invasive Bladder Cancer
- interventionNames
- Biological: Samples of bladder tissue
Primary outcomes (1)
- measure
- PD-L1 status (positive or negative) of the tumor and tumor associated immune cells.
- timeFrame
- Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available