TriangleNCT04640623 · OUTCOME
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
What was measured
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
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 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 | Source count |
|---|---|
| Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease) | 50 |
| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease) | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
- 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 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
- COUNT_OF_PARTICIPANTS
- 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 3 only.
- reporting Status
- POSTED
- time Frame
- From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
- title
- Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice