TriangleNCT02431559 · OUTCOME
Number of Subjects With Best Overall Tumor Response by RECIST 1.1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 36.6 months
What was measured
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Eisenhauer et al 2009).
Analysis population: The population comprises all subjects who received at least one dose of study treatment.
Groups in this outcome
Phase 1, Dose Level 0a
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
Phase 1, Dose Level 0b
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
Phase 1, Dose Level +1
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
Phase 2
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
| Group | Source count |
|---|---|
| Phase 1, Dose Level 0a | 3 |
| Phase 1, Dose Level 0b | 4 |
| Phase 1, Dose Level +1 | 6 |
| Phase 2 | 40 |
Reported measurements
Source class 1
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 4 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 5 | Not reported | Not reported | Not reported | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 15 | Not reported | Not reported | Not reported | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 16 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- title
- CR
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- title
- PR
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 15
- title
- SD
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 16
- title
- PD
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 40
- units
- Participants
- description
- Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Eisenhauer et al 2009).
- groups
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
- id
- OG000
- title
- Phase 1, Dose Level 0a
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
- id
- OG001
- title
- Phase 1, Dose Level 0b
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
- id
- OG002
- title
- Phase 1, Dose Level +1
- description
- Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
- id
- OG003
- title
- Phase 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The population comprises all subjects who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 36.6 months
- title
- Number of Subjects With Best Overall Tumor Response by RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice