TriangleNCT02554812 · OUTCOME
Duration of Response (DR) 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 documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
What was measured
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment 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. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
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 | 12.5 | Not reported | 12.5 | 12.5 | Not reported |
| Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab | 27.4 | Not reported | 20.9 | 33.9 | Not reported |
| Combination A Phase 2 Melanoma: Utomilumab 100 mg + Avelumab | 52.9 | Not reported | 7.9 | 53.2 | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 15.8 | Not reported | 5.7 | 29.5 | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 28.5 | Not reported | 3.8 | 29.7 | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 3.7 | Not reported | 3.7 | 3.7 | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 4.9 | Not reported | 4.9 | 4.9 | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 8.1 | Not reported | 2.5 | 43.1 | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 24.8 | Not reported | 5.6 | 44.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.5
- upper Limit
- 12.5
- value
- 12.5
- group Id
- OG002
- lower Limit
- 20.9
- upper Limit
- 33.9
- value
- 27.4
- group Id
- OG003
- lower Limit
- 7.9
- upper Limit
- 53.2
- value
- 52.9
- group Id
- OG004
- lower Limit
- 5.7
- upper Limit
- 29.5
- value
- 15.8
- group Id
- OG005
- lower Limit
- 3.8
- upper Limit
- 29.7
- value
- 28.5
- group Id
- OG006
- lower Limit
- 3.7
- upper Limit
- 3.7
- value
- 3.7
- group Id
- OG007
- lower Limit
- 4.9
- upper Limit
- 4.9
- value
- 4.9
- group Id
- OG008
- lower Limit
- 2.5
- upper Limit
- 43.1
- value
- 8.1
- group Id
- OG009
- lower Limit
- 5.6
- upper Limit
- 44.0
- value
- 24.8
- 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
- DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
- 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
- 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. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
- title
- Duration of Response (DR) for Combination A
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice