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NCT04640623 · OUTCOME

Cohort 1and 3: Serum Concentration of Cetrelimab

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 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]

What was measured

Serum concentration of cetrelimab 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. n=0 indicated that this time point was not applicable for this arm. This OM was planned to be analyzed for Cohorts 1 and 3 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 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)50
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)27

Reported measurements

Week 0

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)50
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)27
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)10173.6Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)89.623.0Not reportedNot reportedNot reported
Week 3

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)31
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)20
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)10730.6Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)11934.0Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)34
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)19
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)14440.0Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)15581.9Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)26
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)12
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)15538.1Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)17147.0Not reportedNot reportedNot reported
Week 48

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)14
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)5
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)17266.0Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)17549.7Not reportedNot reportedNot reported
Week 60

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)10
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)2
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)14629.6Not reportedNot reportedNot reported
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)NANANot reportedNot reportedPer plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported in separate OM.
Week 84

Analysis denominator · Participants

GroupSource count
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)3
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)0
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)44.229.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        73.6
        value
        101
      2. group Id
        OG001
        spread
        23.0
        value
        89.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Week 0
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.6
        value
        107
      2. group Id
        OG001
        spread
        34.0
        value
        119
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        20
      units
      Participants
    title
    Week 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.0
        value
        144
      2. group Id
        OG001
        spread
        81.9
        value
        155
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.1
        value
        155
      2. group Id
        OG001
        spread
        47.0
        value
        171
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.0
        value
        172
      2. group Id
        OG001
        spread
        49.7
        value
        175
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Week 48
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.6
        value
        146
      2. comment
        Per plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported in separate OM.
        group Id
        OG001
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Week 60
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.0
        value
        44.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Week 84
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Serum concentration of cetrelimab 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 cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
    id
    OG001
    title
    Cohort 3: Cetrelimab IV 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, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. n=0 indicated that this time point was not applicable for this arm. This OM was planned to be analyzed for Cohorts 1 and 3 only.
reporting Status
POSTED
time Frame
At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
title
Cohort 1and 3: Serum Concentration of Cetrelimab
type
SECONDARY
unit Of Measure
mcg/mL

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