TriangleNCT05010629 · OUTCOME
Median Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumor assessments were performed every 9 weeks for up to 20.2 months.
What was measured
PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Analysis population: Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
Groups in this outcome
9-ING-41 + Carboplatin (Part I)
Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
| Group | Source count |
|---|---|
| 9-ING-41 + Carboplatin (Part I) | 16 |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 9-ING-41 + Carboplatin (Part I) | 4.3 | Not reported | 2.1 | 12.5 | Not reported |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | 7.3 | Not reported | 1.9 | 11.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 12.5
- value
- 4.3
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 11.4
- value
- 7.3
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- OG000
- title
- 9-ING-41 + Carboplatin (Part I)
- description
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
- id
- OG001
- title
- Pembrolizumab + 9-ING-41 + Carboplatin (Part II)
- param Type
- MEDIAN
- population Description
- Arms are defined by treatment assignment. Adenoid cystic carcinoma (ACC) and non-ACC represent disease subgroups within each treatment arm and were not assigned to separate treatment arms. Therefore, participants are reported according to treatment assignment rather than histologic subtype.
- reporting Status
- POSTED
- time Frame
- Tumor assessments were performed every 9 weeks for up to 20.2 months.
- title
- Median Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice