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NCT04640623 · OUTCOME

Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)

What was measured

Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.

Analysis population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.

Groups in this outcome

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

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).

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

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.

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

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)53
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)85
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)28

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)67.9Not reported53.780.1Not reported
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)82.4Not reported72.689.8Not reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)46.4Not reported27.566.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.7
        upper Limit
        80.1
        value
        67.9
      2. group Id
        OG001
        lower Limit
        72.6
        upper Limit
        89.8
        value
        82.4
      3. group Id
        OG002
        lower Limit
        27.5
        upper Limit
        66.1
        value
        46.4
denoms
  1. counts
    1. group Id
      OG000
      value
      53
    2. group Id
      OG001
      value
      85
    3. group Id
      OG002
      value
      28
    units
    Participants
description
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    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
    OG002
    title
    Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
param Type
NUMBER
population Description
Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
title
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

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