TriangleNCT04640623 · OUTCOME
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
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 onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
What was measured
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response 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.
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 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) | 36 |
| Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease) | 70 |
| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease) | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease) | 37 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 70
- group Id
- OG002
- value
- 13
- units
- Participants
- description
- DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.
- 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 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)
- description
- Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
- id
- OG002
- 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.
- reporting Status
- POSTED
- time Frame
- From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
- title
- Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice