Participant flow

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

   id

   FG000

   title

   Durvalumab + Gemcitabine + Cisplatin

2. description

   Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

   id

   FG001

   title

   Gemcitabine + Cisplatin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         154

      2. group Id

         FG001

         num Subjects

         197

      type

      Terminated the study

   2. reasons

      1. group Id

         FG000

         num Subjects

         379

      2. group Id

         FG001

         num Subjects

         333

      type

      Continuing study off treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         533

      2. group Id

         FG001

         num Subjects

         530

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         530

      2. group Id

         FG001

         num Subjects

         526

      type

      Started Neoadjuvant Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         417

      2. group Id

         FG001

         num Subjects

         389

      type

      Completed Neoadjuvant Treatment

   4. achievements

      1. group Id

         FG000

         num Subjects

         469

      2. group Id

         FG001

         num Subjects

         441

      type

      Completed Radical Cystectomy

   5. achievements

      1. group Id

         FG000

         num Subjects

         383

      2. group Id

         FG001

         num Subjects

         0

      type

      Started Adjuvant Treatment

   6. achievements

      1. group Id

         FG000

         num Subjects

         288

      2. group Id

         FG001

         num Subjects

         0

      type

      Completed Adjuvant Treatment

   7. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Completion status is reported by treatment phase

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         533

      2. group Id

         FG001

         num Subjects

         530

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Patients randomized to treatments Arm 1 or Arm 2, will be treated according to their renal function. Recruitment for borderline renal function patients will be limited to up to 20% of the targeted global population. Recruitment for patients with T2N0 disease will be limited to approximately 40% of the targeted global population; once the 40% cap has been reached, only T2-4N1M0 and T3-4N0M0 patients will be allowed to be enrolled onto the study. Completion status is reported by treatment phase

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Preserved source evidence · Not medical advice