TriangleNCT02554812 · OUTCOME
Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B
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 (approximately 26 months)
What was measured
OR: CR or PR determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of 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 \<10 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 5 mm, 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 B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
| Group | Source count |
|---|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 14 |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab | 14.3 | Not reported | 1.8 | 42.8 | Not reported |
| Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab | 8.0 | Not reported | 1.0 | 26.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 42.8
- value
- 14.3
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 26.0
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- OR: CR or PR determined by investigator according to RECIST v1.1 from date of first dose of study treatment until date of first documentation of 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 \<10 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 5 mm, appearance of one or more new lesions was considered PD.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG000
- title
- Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
- description
- During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
- id
- OG001
- title
- Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + 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 (approximately 26 months)
- title
- Phase 2: Percentage of Participants With Confirmed OR as Per RECIST v 1.1 by Investigator Assessment for Combination B
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice