NCT06686381View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 15, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

August 15, 2028

Conditions
Muscle-invasive Bladder Cancer
Interventions
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

Trial Locations (1)

Unknown

American University of Beirut, Beirut

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

American University of Beirut Medical Center

OTHER