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

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

NCT06686381 - Tetra-modality Bladder Preservation Strategies in Muscle-invasive Bladder Cancer: TURBT+ Chemo/Immunotherapy+ Radiation Therapy+ Maintenance Immunotherapy vs. W&W | Biotech Hunter | Biotech Hunter