TriangleNCT02554812 · OUTCOME
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment 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 start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)
What was measured
OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (\<)10 millimeter(mm). PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.
Analysis population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.
Groups in this outcome
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 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 2 Melanoma: Utomilumab 100 mg + Avelumab | 10.7 | Not reported | 2.3 | 28.2 | Not reported |
| Combination A Phase 2 SCCHN: Utomilumab 100 mg + Avelumab | 8.6 | Not reported | 1.8 | 23.1 | Not reported |
| Combination A Phase 2 TNBC: Utomilumab 100 mg + Avelumab | 14.3 | Not reported | 3.0 | 36.3 | Not reported |
| Combination A Phase 2 SCLC: Utomilumab 100 mg + Avelumab | 10.0 | Not reported | 0.3 | 44.5 | Not reported |
| Combination A Phase 2 First Line (1L) NSCLC: Utomilumab 100 mg + Avelumab | 4.8 | Not reported | 0.1 | 23.8 | Not reported |
| Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab | 54.5 | Not reported | 23.4 | 83.3 | Not reported |
| Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab | 18.2 | Not reported | 2.3 | 51.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- 28.2
- value
- 10.7
- group Id
- OG001
- lower Limit
- 1.8
- upper Limit
- 23.1
- value
- 8.6
- group Id
- OG002
- lower Limit
- 3.0
- upper Limit
- 36.3
- value
- 14.3
- group Id
- OG003
- lower Limit
- 0.3
- upper Limit
- 44.5
- value
- 10.0
- group Id
- OG004
- lower Limit
- 0.1
- upper Limit
- 23.8
- value
- 4.8
- group Id
- OG005
- lower Limit
- 23.4
- upper Limit
- 83.3
- value
- 54.5
- group Id
- OG006
- lower Limit
- 2.3
- upper Limit
- 51.8
- value
- 18.2
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 35
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 11
- group Id
- OG006
- value
- 11
- units
- Participants
- description
- OR: complete response(CR) or partial response(PR)determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of progressive disease(PD),confirmed by repeat assessments performed no less than 4 weeks after first response. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures less than (\<)10 millimeter(mm). PR: \>=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD: \>=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm, appearance of one or more new lesions was considered PD.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- title
- Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab
- param Type
- NUMBER
- population Description
- The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one treatment the participant was classified according to the first treatment received.
- reporting Status
- POSTED
- time Frame
- From start of the treatment until disease progression or death due to any cause, whichever occurred first (maximum up to 53 months approximately)
- title
- Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment for Combination A
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice