TriangleNCT02903914 · OUTCOME
Percentage of Participants With the Indicated Best Overall Response (BOR)
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
- Not reported
- Time frame
- Until disease progression/study discontinuation (up to approximately 5 years)
What was measured
BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.
Analysis population: REEP. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
Groups in this outcome
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
| Group | Source count |
|---|---|
| Part 1A: INCB001158 50 mg | 6 |
| Part 1A: INCB001158 75 mg | 7 |
| Part 1A: INCB001158 100 mg | 6 |
| Part 1A: INCB001158 150 mg | 6 |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10 |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 13 |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 10 |
| Part 2: INCB001158 100 mg | 73 |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 118 |
Reported measurements
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 1.7 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 7.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 1.4 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 9.3 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 38.5 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 30.1 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 36.4 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 85.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 83.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 70.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 46.2 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 80.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 50.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 44.9 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 14.3 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 4.1 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 4.2 | Not reported | Not reported | Not reported | Not reported |
Not Assessed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 75 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 100 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1A: INCB001158 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 7.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: INCB001158 100 mg | 13.7 | Not reported | Not reported | Not reported | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 3.4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- group Id
- OG005
- value
- 0.0
- group Id
- OG006
- value
- 0.0
- group Id
- OG007
- value
- 0.0
- group Id
- OG008
- value
- 1.7
- title
- Complete Response
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 10.0
- group Id
- OG005
- value
- 7.7
- group Id
- OG006
- value
- 0.0
- group Id
- OG007
- value
- 1.4
- group Id
- OG008
- value
- 9.3
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 16.7
- group Id
- OG003
- value
- 33.3
- group Id
- OG004
- value
- 10.0
- group Id
- OG005
- value
- 38.5
- group Id
- OG006
- value
- 20.0
- group Id
- OG007
- value
- 30.1
- group Id
- OG008
- value
- 36.4
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 66.7
- group Id
- OG001
- value
- 85.7
- group Id
- OG002
- value
- 83.3
- group Id
- OG003
- value
- 66.7
- group Id
- OG004
- value
- 70.0
- group Id
- OG005
- value
- 46.2
- group Id
- OG006
- value
- 80.0
- group Id
- OG007
- value
- 50.7
- group Id
- OG008
- value
- 44.9
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 14.3
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- group Id
- OG005
- value
- 0.0
- group Id
- OG006
- value
- 0.0
- group Id
- OG007
- value
- 4.1
- group Id
- OG008
- value
- 4.2
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 0.0
- group Id
- OG005
- value
- 0.0
- group Id
- OG006
- value
- 0.0
- group Id
- OG007
- value
- 0.0
- group Id
- OG008
- value
- 0.0
- title
- Not Assessed
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- group Id
- OG002
- value
- 0.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 10.0
- group Id
- OG005
- value
- 7.7
- group Id
- OG006
- value
- 0.0
- group Id
- OG007
- value
- 13.7
- group Id
- OG008
- value
- 3.4
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 73
- group Id
- OG008
- value
- 118
- units
- Participants
- description
- BOR was evaluated per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Stable disease (SD): no change in target lesions to qualify for CR, PR, or progressive disease (PD). PD: progression of a target or non-target lesion or presence of a new lesion. Missing: participant had a missing BOR because there were no post-Baseline tumor assessments. Pleural mesothelioma was evaluated using modified RECIST criteria.
- groups
- description
- INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
- id
- OG000
- title
- Part 1A: INCB001158 50 mg
- description
- INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG001
- title
- Part 1A: INCB001158 75 mg
- description
- INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG002
- title
- Part 1A: INCB001158 100 mg
- description
- INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG003
- title
- Part 1A: INCB001158 150 mg
- description
- INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
- id
- OG004
- title
- Part 1B: INCB001158 50 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG005
- title
- Part 1B: INCB001158 75 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG006
- title
- Part 1B: INCB001158 100 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG007
- title
- Part 2: INCB001158 100 mg
- description
- INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG008
- title
- Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
- param Type
- NUMBER
- population Description
- REEP. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
- reporting Status
- POSTED
- time Frame
- Until disease progression/study discontinuation (up to approximately 5 years)
- title
- Percentage of Participants With the Indicated Best Overall Response (BOR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice