NCT06686381

Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W

A Phase II, Randomized, Non-comparative Double Arm, Open-label, 2-stage, Multicenter Study to Evaluate the Efficacy and Safety of 2 Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer With Maximum TURBT Followed by Induction Platinum-based Chemotherapy/Avelumab Followed by Radiation Therapy Then Maintenance Avelumab or Watch and Wait Approach

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: American University of Beirut Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of adding the immunotherapy Avelumab as a fourth component, alongside tumor removal, chemotherapy, and radiation, to increase the chance of preserving the bladder in the treatment of muscle-invasive bladder cancer.

Detailed description

Muscle-invasive bladder cancer (MIBC) is an aggressive form of bladder cancer, with a 5-year survival rate of about 40%. The standard treatment for MIBC is induction platinum-based chemotherapy followed by radical cystectomy. Recently bladder preservation strategies have emerged as an alternative to radical cystectomy, particularly useful for patients who are unfit for surgery or would rather opt for non-surgical approaches. Knowing the high risks related to surgery and its significant complications, the investigators propose to implement 2 tetra-modalities treatment strategies to increase the chance of preserving the bladder and decrease the need of salvage cystectomy. The purpose of this study is to assess the efficacy and safety of 2 bladder-preservation treatments plans called tetra-modalities: First plan: * maximium TURBT * chemo-immunotherapy as induction phase (Avelumab added to chemotherapy) * radiation therapy * maintenance phase with Avelumab Second plan: * Maximum TURBT * chemo-immunotherapy as induction phase (Avelumab added to chemotherapy) * radiation therapy * Watch and wait Both tetra-modalities duration will last maximum of 2 years from patient inclusion. These treatment plans are based on the synergistic action between immunotherapy, chemotherapy, and radiotherapy. The use of Avelumab in the maintenance group is supported by its proven success in treating advanced cancer and various studies looking at immunotherapy as a way to avoid or delay bladder removal.

Conditions

• Muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
PROCEDURE	Maximum TURBT	Total removal of the bladder tumor through TURBT
DRUG	Chemotherapy + Immunotherapy Induction	Chemotherapy: DDMVAC (6 cycles) or Gemcitabine-Cisplatin (4 cycles) Immunotherapy: Avelumab (6 cycles)
RADIATION	Radiotherapy	Hypofractionated radiotherapy: 20 fractions, 55 Grays
DRUG	Immunotherapy Maintenance	Maintenance Avelumab every 2 weeks for 12 months
OTHER	Watchful waiting with supportive care	1 year watch and wait

Timeline

• Start date: 2025-04-15
• Primary completion: 2028-08-01
• Completion: 2028-08-15
• First posted: 2024-11-13
• Last updated: 2025-02-05

Locations

1 site across 1 country: Lebanon