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NCT04640623 · OUTCOME

Cohort 4: Disease-free Survival (DFS)

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
MEDIAN
Unit
months
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

DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.

Analysis population: FAS included all enrolled participants who received at least 1 dose of study treatment.

Groups in this outcome

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

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.

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 4: TAR-200 Monotherapy (Papillary Disease Only)52

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)NANot reported12.12NAMedian and upper bound of 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and upper bound of 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        12.12
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
param Type
MEDIAN
population Description
FAS included all enrolled participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
title
Cohort 4: Disease-free Survival (DFS)
type
PRIMARY
unit Of Measure
months

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

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