TriangleNCT02554812 · OUTCOME
Time to Tumor Response (TTR) for Combination A
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
What was measured
TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
Analysis population: Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
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.
Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
During Phase 2 participants with melanoma 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 2 SCCHN: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) 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 2 TNBC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Triple Negative Breast Cancer (TNBC) 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 2 SCLC: Utomilumab 100 mg + Avelumab
During Phase 2 participants with Squamous cell lung cancer (SCLC) 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 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
During Phase 2 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 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
| Group | Source count |
|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 1 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 0 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 3 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 3 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 1 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 6 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 3.6 | Not reported | 3.6 | 3.6 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 1.9 | Not reported | 1.7 | 11.3 | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1.9 | Not reported | 1.8 | 7.4 | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1.8 | Not reported | 1.5 | 3.5 | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1.7 | Not reported | 1.6 | 1.7 | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 1.7 | Not reported | 1.7 | 1.7 | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1.6 | Not reported | 1.6 | 1.6 | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 3.7 | Not reported | 1.8 | 7.4 | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 2.7 | Not reported | 1.6 | 3.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- 3.6
- value
- 3.6
- group Id
- OG002
- lower Limit
- 1.7
- upper Limit
- 11.3
- value
- 1.9
- group Id
- OG003
- lower Limit
- 1.8
- upper Limit
- 7.4
- value
- 1.9
- group Id
- OG004
- lower Limit
- 1.5
- upper Limit
- 3.5
- value
- 1.8
- group Id
- OG005
- lower Limit
- 1.6
- upper Limit
- 1.7
- value
- 1.7
- group Id
- OG006
- lower Limit
- 1.7
- upper Limit
- 1.7
- value
- 1.7
- group Id
- OG007
- lower Limit
- 1.6
- upper Limit
- 1.6
- value
- 1.6
- group Id
- OG008
- lower Limit
- 1.8
- upper Limit
- 7.4
- value
- 3.7
- group Id
- OG009
- lower Limit
- 1.6
- upper Limit
- 3.7
- value
- 2.7
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 2
- units
- Participants
- description
- TTR was defined, for participants with an objective response (confirmed CR or PR), as the time from the start date (the date of first dose of treatment) to the first documentation of objective response (CR or PR) which was subsequently confirmed. Per RECIST v1.1: CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to \<10 mm. PR: at least a 30% decrease in sum of diameter of all target lesions, taking as reference baseline sum of diameters.
- dispersion Type
- Full Range
- 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
- description
- During Phase 2 participants with melanoma 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
- OG003
- title
- Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous Cell Carcinoma of the Head and Neck (SCCHN) 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
- OG004
- title
- Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Triple Negative Breast Cancer (TNBC) 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
- OG005
- title
- Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with Squamous cell lung cancer (SCLC) 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
- OG006
- title
- Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 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
- OG007
- title
- Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab
- description
- During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG008
- title
- Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
- description
- During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
- id
- OG009
- title
- Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
- param Type
- MEDIAN
- population Description
- Analysis population included all participants who received at least one dose of study drug and who had confirmed CR or PR. Participants were classified according to study treatment actually received. If participant received more than one treatment, participant was classified according to first treatment received. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure with at least 1 confirmed complete response or partial response.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until first documentation of CR or PR (maximum up to 7.3 years)
- title
- Time to Tumor Response (TTR) for Combination A
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice