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

NCT06686381 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-05

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • American University of Beirut Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2028-08-31
Completion
2028-08-15

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686381 on ClinicalTrials.gov