TriangleNCT02452424 · OUTCOME
Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
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
- 1 year (Dose Escalation); 2 years (Dose Expansion)
What was measured
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
Analysis population: Safety events were assessed in the Safety Population.
Groups in this outcome
Dose Escalation: 400 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
Dose Escalation: 600 mg/Day
Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Escalation: 600 mg/Day (Liver Metastases
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Escalation: 600 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Escalation: 800 mg/Day (Liver Metastases)
Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
Dose Escalation: 800 mg/Day (no Liver Metastases)
Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
Dose Expansion: Melanoma
Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Expansion: NSCLC
Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Expansion: SCCHN
Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
Dose Expansion: GIST
Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
| Group | Source count |
|---|---|
| Dose Escalation: 400 mg/Day | 4 |
| Dose Escalation: 600 mg/Day | 3 |
| Dose Escalation: 600 mg/Day (Liver Metastases | 7 |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 9 |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 4 |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 6 |
| Dose Expansion: Melanoma | 13 |
| Dose Expansion: NSCLC | 8 |
| Dose Expansion: Ovarian Cancer | 15 |
| Dose Expansion: SCCHN | 3 |
| Dose Expansion: GIST | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 12 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 15 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 12
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 15
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 15
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 6
- units
- Participants
- description
- Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
- groups
- description
- Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 400 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 200 mg in the evening).
- id
- OG000
- title
- Dose Escalation: 400 mg/Day
- description
- Participants received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG001
- title
- Dose Escalation: 600 mg/Day
- description
- Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG002
- title
- Dose Escalation: 600 mg/Day (Liver Metastases
- description
- Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG003
- title
- Dose Escalation: 600 mg/Day (no Liver Metastases)
- description
- Participants with liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
- id
- OG004
- title
- Dose Escalation: 800 mg/Day (Liver Metastases)
- description
- Participants with no liver metastases received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 800 mg/day (administered twice daily \[BID\] as a split dose of 400 mg in the morning and 400 mg in the evening).
- id
- OG005
- title
- Dose Escalation: 800 mg/Day (no Liver Metastases)
- description
- Participants with melanoma received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG006
- title
- Dose Expansion: Melanoma
- description
- Participants with NSCLC received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG007
- title
- Dose Expansion: NSCLC
- description
- Participants with ovarian cancer received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG008
- title
- Dose Expansion: Ovarian Cancer
- description
- Participants with SCCHN received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG009
- title
- Dose Expansion: SCCHN
- description
- Participants with GIST received pembrolizumab 200 mg IV every 3 weeks in combination with PLX3397 at 600 mg/day (administered twice daily \[BID\] as a split dose of 200 mg in the morning and 400 mg in the evening).
- id
- OG010
- title
- Dose Expansion: GIST
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety events were assessed in the Safety Population.
- reporting Status
- POSTED
- time Frame
- 1 year (Dose Escalation); 2 years (Dose Expansion)
- title
- Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice