TriangleNCT02554812 · OUTCOME
DR for Combination C
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 included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Combination C Phase 1b: PD 0360324 50 mg + Avelumab
During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
Combination C Phase 1b: PD 0360324 100 mg + Avelumab
During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab
During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
| Group | Source count |
|---|---|
| Combination C Phase 1b: PD 0360324 50 mg + Avelumab | 1 |
| Combination C Phase 1b: PD 0360324 100 mg + Avelumab | 2 |
| Combination C Phase 1b: PD 0360324 150 mg + Avelumab | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination C Phase 1b: PD 0360324 50 mg + Avelumab | 7.1 | Not reported | 7.1 | 7.1 | Not reported |
| Combination C Phase 1b: PD 0360324 100 mg + Avelumab | 7.1 | Not reported | 5.6 | 8.6 | Not reported |
| Combination C Phase 1b: PD 0360324 150 mg + Avelumab | 13.1 | Not reported | 13.1 | 13.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- 7.1
- value
- 7.1
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 8.6
- value
- 7.1
- group Id
- OG002
- lower Limit
- 13.1
- upper Limit
- 13.1
- value
- 13.1
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- 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 received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
- id
- OG000
- title
- Combination C Phase 1b: PD 0360324 50 mg + Avelumab
- description
- During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG001
- title
- Combination C Phase 1b: PD 0360324 100 mg + Avelumab
- description
- During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
- id
- OG002
- title
- Combination C Phase 1b: PD 0360324 150 mg + Avelumab
- param Type
- MEDIAN
- population Description
- Full analysis set included all enrolled participants who received at least one 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
- DR for Combination C
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice