TriangleNCT02554812 · OUTCOME
Progression-free Survival (PFS) 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
- 95% Confidence Interval
- Time frame
- From first dose of study drug until first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
What was measured
PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
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.
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 | 29 |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 28 |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 29 |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 28 |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 35 |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10 |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 21 |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 11 |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab | 2.2 | Not reported | 1.8 | 5.3 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 100 mg + Avelumab | 1.8 | Not reported | 1.7 | 2.3 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 1.9 | Not reported | 1.7 | 3.7 | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 1.9 | Not reported | 1.8 | 3.9 | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 1.9 | Not reported | 1.8 | 3.7 | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 1.8 | Not reported | 1.4 | 5.5 | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 1.6 | Not reported | 0.3 | 5.4 | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 1.8 | Not reported | 1.7 | 3.6 | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 11.9 | Not reported | 4.2 | NA | Upper limit of 95% CI was not estimable as there were less number of participants with an event. |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 5.5 | Not reported | 0.7 | 43.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 5.3
- value
- 2.2
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 2.3
- value
- 1.8
- group Id
- OG002
- lower Limit
- 1.7
- upper Limit
- 3.7
- value
- 1.9
- group Id
- OG003
- lower Limit
- 1.8
- upper Limit
- 3.9
- value
- 1.9
- group Id
- OG004
- lower Limit
- 1.8
- upper Limit
- 3.7
- value
- 1.9
- group Id
- OG005
- lower Limit
- 1.4
- upper Limit
- 5.5
- value
- 1.8
- group Id
- OG006
- lower Limit
- 0.3
- upper Limit
- 5.4
- value
- 1.6
- group Id
- OG007
- lower Limit
- 1.7
- upper Limit
- 3.6
- value
- 1.8
- comment
- Upper limit of 95% CI was not estimable as there were less number of participants with an event.
- group Id
- OG008
- lower Limit
- 4.2
- upper Limit
- NA
- value
- 11.9
- group Id
- OG009
- lower Limit
- 0.7
- upper Limit
- 43.5
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 29
- group Id
- OG003
- value
- 28
- group Id
- OG004
- value
- 35
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 21
- group Id
- OG008
- value
- 11
- group Id
- OG009
- value
- 11
- units
- Participants
- description
- PFS as assessed by investigator per RECIST v1.1, was defined as time (in months) from date of first dose of study drug to date of first documentation of PD or death due to any cause or data censoring date, whichever occurred first. PD: \>= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on study treatment (this included baseline sum if that was smallest on study treatment). The sum must also demonstrate absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PFS was analyzed by Kaplan-Meier method. PFS data was censored on the date the last adequate tumor assessment for participants without an event (PD or death), for participants who started new anti-cancer treatment prior to PFS event, for participants with a PFS event after \>=2 missing tumor assessments.
- 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
- 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
- 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 first documentation of PD or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
- title
- Progression-free Survival (PFS) for Combination A
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice