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NCT04640623 · OUTCOME

Cohort 4: Urine Concentration 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 Weeks 3, 6, 9, 15, 18, and 21

What was measured

Urine concentrations of gemcitabine and dFdU were reported.

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, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. This OM was planned to be analyzed for Cohort 4 only.

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)18

Reported measurements

Gemcitabine: Week 3

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)16
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)7.917.19Not reportedNot reportedNot reported
Gemcitabine: Week 6

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)6
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)2.662.13Not reportedNot reportedNot reported
Gemcitabine: Week 9

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)12
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)3.046.59Not reportedNot reportedNot reported
Gemcitabine: Week 15

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)11
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)9.659.91Not reportedNot reportedNot reported
Gemcitabine: Week 18

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)4
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)3.655.43Not reportedNot reportedNot reported
Gemcitabine: Week 21

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)7
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0.7441.58Not reportedNot reportedNot reported
dFdU: Week 3

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)18
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)1.332.40Not reportedNot reportedNot reported
dFdU: Week 6

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)6
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)6.1210.4Not reportedNot reportedNot reported
dFdU: Week 9

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)13
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)6.045.45Not reportedNot reportedNot reported
dFdU: Week 15

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)12
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)5.065.48Not reportedNot reportedNot reported
dFdU: Week 18

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)5
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)2.092.67Not reportedNot reportedNot reported
dFdU: Week 21

Analysis denominator · Participants

GroupSource count
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)7
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)6.316.23Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.19
        value
        7.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Gemcitabine: Week 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.13
        value
        2.66
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Gemcitabine: Week 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.59
        value
        3.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Gemcitabine: Week 9
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.91
        value
        9.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Gemcitabine: Week 15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.43
        value
        3.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Gemcitabine: Week 18
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.58
        value
        0.744
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Gemcitabine: Week 21
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.40
        value
        1.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    dFdU: Week 3
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.4
        value
        6.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    dFdU: Week 6
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.45
        value
        6.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    dFdU: Week 9
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.48
        value
        5.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    dFdU: Week 15
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.67
        value
        2.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    dFdU: Week 18
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.23
        value
        6.31
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    dFdU: Week 21
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Urine concentrations of gemcitabine and dFdU were reported.
dispersion Type
Standard Deviation
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
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, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. This OM was planned to be analyzed for Cohort 4 only.
reporting Status
POSTED
time Frame
At Weeks 3, 6, 9, 15, 18, and 21
title
Cohort 4: Urine Concentration 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