NCT04640623 · OUTCOME

Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)

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: MEAN
Unit: mcg/mL
Interval / dispersion: Standard Deviation
Time frame: At Week 0

What was measured

Cmax was defined as maximum observed urine concentration.

Analysis population: 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. This OM was planned to be analyzed for Cohorts 1 and 2 only.

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.

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

Analysis denominator · Participants

Group	Source count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)	18
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)	21

Reported measurements

Gemcitabine: Week 0

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)	17.4	10.3	Not reported	Not reported	Not reported
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)	12.8	6.52	Not reported	Not reported	Not reported

dFdU: Week 0

Values in mcg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)	10.3	11.0	Not reported	Not reported	Not reported
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)	10.6	9.26	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10.3
value
17.4
group Id
OG001
spread
6.52
value
12.8
title
Gemcitabine: Week 0
categories
measurements
group Id
OG000
spread
11.0
value
10.3
group Id
OG001
spread
9.26
value
10.6
title
dFdU: Week 0

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
21
units
Participants

description

Cmax was defined as maximum observed urine concentration.

dispersion Type

Standard Deviation

groups

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)
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)

param Type

MEAN

population Description

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. This OM was planned to be analyzed for Cohorts 1 and 2 only.

reporting Status

POSTED

time Frame

At Week 0

title

Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)

type

SECONDARY

unit Of Measure

mcg/mL

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

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