TriangleNCT05070247 · OUTCOME
Dose Escalation: Disease Control Rate (DCR)
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
- Up to approximately 32.8 months
What was measured
DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (\>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
Analysis population: The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
Groups in this outcome
Single Agent Dose Escalation: TAK-500 8 µg/kg
Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: TAK-500 16 µg/kg
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg
Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
| Group | Source count |
|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | 2 |
| Single Agent Dose Escalation: TAK-500 16 µg/kg | 4 |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | 2 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | 4 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | 3 |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | 0 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | 6 |
| Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | 2 |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | 4 |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | 4 |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | 5 |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | 33.3 | Not reported | 0.8 | 90.6 | Not reported |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | 50.0 | Not reported | 1.3 | 98.7 | Not reported |
| Single Agent Dose Escalation: TAK-500 16 µg/kg | 50.0 | Not reported | 6.8 | 93.2 | Not reported |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | 0 | Not reported | NA | NA | 95% CI was not estimable as no participant had the event. |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | 25.0 | Not reported | 0.6 | 80.6 | Not reported |
| Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | 50.0 | Not reported | 6.8 | 93.2 | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | 60.0 | Not reported | 14.7 | 94.7 | Not reported |
| Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | 50.0 | Not reported | 1.3 | 98.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 90.6
- value
- 33.3
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 98.7
- value
- 50.0
- group Id
- OG002
- lower Limit
- 6.8
- upper Limit
- 93.2
- value
- 50.0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- 95% CI was not estimable as no participant had the event.
- group Id
- OG009
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG010
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25.0
- group Id
- OG011
- lower Limit
- 6.8
- upper Limit
- 93.2
- value
- 50.0
- group Id
- OG012
- lower Limit
- 14.7
- upper Limit
- 94.7
- value
- 60.0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 4
- units
- Participants
- description
- DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (\>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.
- id
- OG000
- title
- Single Agent Dose Escalation: TAK-500 8 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG001
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
- description
- Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG002
- title
- Single Agent Dose Escalation: TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG003
- title
- Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
- id
- OG004
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG005
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG006
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG007
- title
- Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG008
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
- description
- Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.
- id
- OG009
- title
- Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
- id
- OG010
- title
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
- description
- Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.
- id
- OG011
- title
- Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
- param Type
- NUMBER
- population Description
- The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.
- reporting Status
- POSTED
- time Frame
- Up to approximately 32.8 months
- title
- Dose Escalation: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice