TriangleNCT05010629 · OUTCOME
Median Overall Survival (OS)
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
- Up to 38.1 months
What was measured
Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
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) | 15.6 | Not reported | 5.4 | 27.8 | Not reported |
| Pembrolizumab + 9-ING-41 + Carboplatin (Part II) | NA | Not reported | 9.7 | NA | Median OS was not reached. The upper bound of the OS confidence interval is not available due to insufficient observed events at this time. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.4
- upper Limit
- 27.8
- value
- 15.6
- comment
- Median OS was not reached. The upper bound of the OS confidence interval is not available due to insufficient observed events at this time.
- group Id
- OG001
- lower Limit
- 9.7
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 16
- units
- Participants
- description
- Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.
- 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
- Up to 38.1 months
- title
- Median Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice