Participant flow

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy · Source last updated 2026-08-28

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

groups

1. description

   Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).

   id

   FG000

   title

   Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)

2. description

   Participants with CIS with or without papillary disease, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.

   id

   FG001

   title

   Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)

3. description

   Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.

   id

   FG002

   title

   Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)

4. description

   Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.

   id

   FG003

   title

   Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         66

      3. group Id

         FG002

         num Subjects

         25

      4. group Id

         FG003

         num Subjects

         45

      type

      Ongoing

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         5

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         85

      3. group Id

         FG002

         num Subjects

         28

      4. group Id

         FG003

         num Subjects

         52

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         78

      3. group Id

         FG002

         num Subjects

         28

      4. group Id

         FG003

         num Subjects

         50

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with high-risk non-muscle invasive bladder cancer (NMIBC) and carcinoma in situ (CIS with or without papillary or papillary only) unresponsive to intravesical bacillus Calmette-Guérin (BCG) who were ineligible for or elected not to undergo radical cystectomy were enrolled in the study. Results are currently reported up to primary completion date 03-Jul-25. Remaining results will be posted upon study completion.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice