TriangleNCT02452424 · OUTCOME
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
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
Objective response rate was defined as the proportion of subjects who achieved a best disease response of either Complete or Partial (CR or PR) based on the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed generally by MRI, CT, or PET-CT and are summarized as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Participants who discontinued study therapy due to clinical progression, radiographic progression, or death without the required tumor assessments were considered to be non-responders in the Objective Response Rate (ORR) calculation. The efficacy analysis included all subjects with baseline tumor measurements who received at least 1 dose of study drug.
Analysis population: Overall best response was assessed in the Efficacy Analysis Set.
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 of 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 of 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
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 0 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 3 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 3 | Not reported | Not reported | Not reported | Not reported |
Not evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 0 | Not reported | Not reported | Not reported | Not reported |
Not assessed for response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: 400 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (Liver Metastases | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 600 mg/Day (no Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (Liver Metastases) | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: 800 mg/Day (no Liver Metastases) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Melanoma | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: NSCLC | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Ovarian Cancer | 4 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: SCCHN | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: GIST | 0 | 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
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- title
- Complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- title
- Partial response
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 3
- title
- Progressive disease
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 3
- title
- Stable disease
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- title
- Not evaluable
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- title
- Not assessed for response
- 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
- Objective response rate was defined as the proportion of subjects who achieved a best disease response of either Complete or Partial (CR or PR) based on the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed generally by MRI, CT, or PET-CT and are summarized as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Participants who discontinued study therapy due to clinical progression, radiographic progression, or death without the required tumor assessments were considered to be non-responders in the Objective Response Rate (ORR) calculation. The efficacy analysis included all subjects with baseline tumor measurements who received at least 1 dose of study drug.
- 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 of 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 of 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
- Overall best response was assessed in the Efficacy Analysis Set.
- reporting Status
- POSTED
- time Frame
- 1 year (Dose Escalation); 2 years (Dose Expansion)
- title
- Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice