Non-muscle-invasive Bladder Cancer Clinical Trial
Official title:
Bladder PREserVation by RadioTherapy and Immunotherapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer
About two-thirds of newly diagnosed cases of bladder cancer are non-muscle-invasive bladder
cancer (NMIBC). It is advocated that patients with high-risk NMIBC receive an adjuvant course
of intravesical Bacille Calmette-Guerin (BCG) as first-line treatment. However, a substantial
proportion of patients will 'fail' BCG. Radical cystectomy remains the treatment of choice
for NMIBC who have failed intravesical therapy, but there are situations when surgery is not
feasible due to competing co-morbidities or a patient's desire for bladder preservation. For
these patients, the potential options available are limited.
In MIBC, radiotherapy (RT) in association with chemotherapy, has been shown to produce
10-year overall survival rates comparable to those of radical cystectomy in selected cases.
At the opposite, results from trials assessing radiotherapy with or without chemotherapy in
patients with NMIBC are less documented and discordant.
Immunotherapy with immune-checkpoint blockade therapies is increasing as an option and has
shown very promising results for several cancers, including bladder carcinoma.
An established body of published work has shown that radiation enhances many of the steps
needed for the generation of antigen-specific immune responses, including inflammatory
tumor-cell death, dendritic cell activation, and antigen cross-presentation. Several groups
have reported improved local control when checkpoint blockade immunotherapy is added to
radiation in different tumor types. On the one hand, radiotherapy might stimulate the
induction of local endogenous immune responses by anti-PD-1 treatment. On the other hand,
active immune stimulation by anti-PD-1 treatment within the tumor microenvironment might
maximize radiation-induced antitumor immunity.
Combination immunoradiotherapy using PD-1/PD-L1 signaling blockade could therefore offer an
interesting strategy in bladder tumors, especially as an optional bladder preservation
treatment for BCG unresponsive NMIBC.
The originality of the therapeutic strategy is the use of radiation (local treatment)
combined with checkpoint blockade immunotherapy (systemic treatment). Radiotherapy might
increase response rates by creating a more permissive tumor microenvironment through
increasing PD-L1 expression on tumor cells and stimulating the accumulation and activation of
CD8+ T cells.
Avelumab seems to have a specific cytotoxic activity suggesting its interest in local control
of the disease, especially in association with radiotherapy.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05483868 -
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT05547516 -
Blue Laser -5ala Photodynamic Therapy (PDT) in High-Risk Non-muscle Invasive Bladder Cancer (NMIBC) Patients
|
N/A | |
| Not yet recruiting |
NCT05580354 -
Safety and Efficacy of BCG Combined With Tislelizumab for BCG-untreated Patients With High-risk Non-muscle Invasive Bladder Cancer
|
Phase 4 | |
| Recruiting |
NCT05519241 -
A Phase I Intravesical PPM Therapy for NMIBC
|
Phase 1 | |
| Not yet recruiting |
NCT05002556 -
AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
|
||
| Recruiting |
NCT05544552 -
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05796375 -
Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance
|
N/A | |
| Active, not recruiting |
NCT03528694 -
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
|
Phase 3 | |
| Recruiting |
NCT05790850 -
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
|
N/A | |
| Completed |
NCT03664258 -
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
|
||
| Not yet recruiting |
NCT05962541 -
Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
|
Phase 4 | |
| Active, not recruiting |
NCT05864599 -
External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the CUETO Group
|
||
| Recruiting |
NCT05710848 -
A Study of STM-416 Administered to Patients Undergoing TURBT for Recurrent Bladder Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05232136 -
OH2 Oncolytic Viral Therapy in Non-Muscle-Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05825950 -
Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
|
||
| Recruiting |
NCT05626101 -
Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study
|
N/A | |
| Recruiting |
NCT05538663 -
Intravesical BCG vs GEMDOCE in NMIBC
|
Phase 3 | |
| Recruiting |
NCT06245759 -
The Prognostic Impact of Tumor Location in Non-Muscle-Invasive Bladder Cancer Patients
|
||
| Active, not recruiting |
NCT04690699 -
LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT05675176 -
Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer
|