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NCT04640623 · OUTCOME

Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (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
microgram per milliliter (mcg/mL)
Interval / dispersion
Standard Deviation
Time frame
Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose

What was measured

Plasma concentrations of gemcitabine and dFdU were reported.

Analysis population: FAS was analyzed. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM), "n" (number analyzed) signifies number of participants evaluable at specific timepoints. N=0 because data was not collected or analyzed, as urine was the major pharmacokinetic matrix; therefore, plasma Gemcitabine and dFdU concentrations were not assessed in the Cohort 4. This OM was planned to be analyzed for Cohorts 1, 2, and 4 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.

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 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)42
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)80
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0

Reported measurements

Gemcitabine: Week 0 (predose)

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)42
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)80
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and standard deviation (SD) cannot be reported as the value was below quantification limit (BQL) (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 3

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)9
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 6

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)11
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 9

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)18
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 15

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)13
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 18

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)3
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)12
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Gemcitabine: Week 21

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)8
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)13
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 0 (predose)

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)42
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)80
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 3

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)9
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 6

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)11
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 9

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)18
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 15

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)7
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)13
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 18

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)3
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)12
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
dFdU: Week 21

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)8
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)13
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)0
Values in microgram per milliliter (mcg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedMean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean and standard deviation (SD) cannot be reported as the value was below quantification limit (BQL) (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 0 (predose)
  2. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 3
  3. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 6
  4. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 9
  5. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 15
  6. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 18
  7. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Gemcitabine: Week 21
  8. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        80
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    dFdU: Week 0 (predose)
  9. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    dFdU: Week 3
  10. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    dFdU: Week 6
  11. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    dFdU: Week 9
  12. categories
    1. measurements
      1. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    dFdU: Week 15
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      80
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Plasma concentrations of gemcitabine and dFdU were reported.
dispersion Type
Standard Deviation
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 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
    OG002
    title
    Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
param Type
MEAN
population Description
FAS was analyzed. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM), "n" (number analyzed) signifies number of participants evaluable at specific timepoints. N=0 because data was not collected or analyzed, as urine was the major pharmacokinetic matrix; therefore, plasma Gemcitabine and dFdU concentrations were not assessed in the Cohort 4. This OM was planned to be analyzed for Cohorts 1, 2, and 4 only.
reporting Status
POSTED
time Frame
Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
title
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
type
SECONDARY
unit Of Measure
microgram per milliliter (mcg/mL)

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