TriangleNCT02554812 · OUTCOME
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination A
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
- From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
What was measured
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR), were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug.
Groups in this outcome
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 29 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 28 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 3.4 | Not reported | 0.1 | 17.8 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 | Not reported | 0.0 | 12.3 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 10.3 | Not reported | 2.2 | 27.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 17.8
- value
- 3.4
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 12.3
- value
- 0
- group Id
- OG002
- lower Limit
- 2.2
- upper Limit
- 27.4
- value
- 10.3
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 29
- units
- Participants
- description
- OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR), were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
- id
- OG000
- title
- Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG001
- title
- Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab
- description
- During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG002
- title
- Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
- param Type
- NUMBER
- population Description
- Full analysis set includes all randomized participants for Cohorts A1, A2, A3, A9, and A10 and all enrolled participants for Cohorts A4, A5, A6, A7, and A8 who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)
- title
- Phase 1b: Percentage of Participants With Objective Response (OR) for Combination A
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice