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NCT04640623 · OUTCOME

Cohort 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 60 (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. Per plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported.

Groups in this outcome

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 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)2

Reported measurements

Participant 1

Analysis denominator · Participants

GroupSource count
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)1
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)141.32217NANot reportedNot reportedSD cannot be calculated as only one participant was analyzed.
Participant 2

Analysis denominator · Participants

GroupSource count
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)1
Values in mcg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)121.45383NANot reportedNot reportedSD cannot be calculated as only one participant was analyzed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        SD cannot be calculated as only one participant was analyzed.
        group Id
        OG000
        spread
        NA
        value
        141.32217
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1
  2. categories
    1. measurements
      1. comment
        SD cannot be calculated as only one participant was analyzed.
        group Id
        OG000
        spread
        NA
        value
        121.45383
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    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 cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
    id
    OG000
    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. Per plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported.
reporting Status
POSTED
time Frame
At Weeks 60 (EOI)
title
Cohort 3: Serum Concentration of Cetrelimab
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