TriangleNCT05010629 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.
What was measured
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Analysis population: According to the protocol, all evaluable patients were combined for the primary analysis.
Groups in this outcome
Evaluable Patients Popupulation
Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 in participants enrolled in Part II (lead-in therapy). 9-ING-41 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 once per 21-day cycle on Day 1 for up to 1 year.
| Group | Source count |
|---|---|
| Evaluable Patients Popupulation | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Evaluable Patients Popupulation | 9.4 | Not reported | 2.0 | 25.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 25.0
- value
- 9.4
- denoms
- counts
- group Id
- OG000
- value
- 32
- units
- Participants
- description
- ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 in participants enrolled in Part II (lead-in therapy). 9-ING-41 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 once per 21-day cycle on Day 1 for up to 1 year.
- id
- OG000
- title
- Evaluable Patients Popupulation
- param Type
- NUMBER
- population Description
- According to the protocol, all evaluable patients were combined for the primary analysis.
- reporting Status
- POSTED
- time Frame
- Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.
- title
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice