A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported

Safety events were assessed in the Safety Population.

→

secondary · POSTED

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.

Overall best response was assessed in the Efficacy Analysis Set.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id: NCT02452424
trial label: A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 11
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
source section id
NCT02452424-om-0000
source outcome index
0
endpoint
Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab
endpoint definition
Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported
time origin
1 year (Dose Escalation); 2 years (Dose Expansion)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Safety events were assessed in the Safety Population.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0001
source section id
NCT02452424-om-0001
source outcome index
1
endpoint
Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397
endpoint definition
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.
time origin
1 year (Dose Escalation); 2 years (Dose Expansion)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Overall best response was assessed in the Efficacy Analysis Set.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG000
arm label
Dose Escalation: 400 mg/Day
regimen
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).
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG001
arm label
Dose Escalation: 600 mg/Day
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG002
arm label
Dose Escalation: 600 mg/Day (Liver Metastases
regimen
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).
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG003
arm label
Dose Escalation: 600 mg/Day (no Liver Metastases)
regimen
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).
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG004
arm label
Dose Escalation: 800 mg/Day (Liver Metastases)
regimen
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).
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG005
arm label
Dose Escalation: 800 mg/Day (no Liver Metastases)
regimen
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).
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG006
arm label
Dose Expansion: Melanoma
regimen
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).
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG006
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG007
arm label
Dose Expansion: NSCLC
regimen
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).
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG007
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG008
arm label
Dose Expansion: Ovarian Cancer
regimen
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).
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG008
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG009
arm label
Dose Expansion: SCCHN
regimen
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).
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG009
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0000
arm key
OG010
arm label
Dose Expansion: GIST
regimen
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).
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0000#groups/OG010
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
outcome key
om-0001
arm key
OG000
arm label
Dose Escalation: 400 mg/Day
regimen
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).
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02452424-om-0001#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG000
source section id
NCT02452424-ae
event group key
EG000
event group label
Dose Escalation: 400 mg/Day
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG001
source section id
NCT02452424-ae
event group key
EG001
event group label
Dose Escalation: 600 mg/Day
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG002
source section id
NCT02452424-ae
event group key
EG002
event group label
Dose Escalation: 600 mg/Day (Liver Metastases
serious affected
3
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG003
source section id
NCT02452424-ae
event group key
EG003
event group label
Dose Escalation: 600 mg/Day (no Liver Metastases)
serious affected
3
serious at risk
9
other affected
9
other at risk
9
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG004
source section id
NCT02452424-ae
event group key
EG004
event group label
Dose Escalation: 800 mg/Day (Liver Metastases)
serious affected
2
serious at risk
4
other affected
4
other at risk
4
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG005
source section id
NCT02452424-ae
event group key
EG005
event group label
Dose Escalation: 800 mg/Day (no Liver Metastases)
serious affected
3
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG006
source section id
NCT02452424-ae
event group key
EG006
event group label
Dose Expansion: Melanoma
serious affected
3
serious at risk
13
other affected
12
other at risk
13
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG007
source section id
NCT02452424-ae
event group key
EG007
event group label
Dose Expansion: NSCLC
serious affected
3
serious at risk
8
other affected
8
other at risk
8
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG008
source section id
NCT02452424-ae
event group key
EG008
event group label
Dose Expansion: Ovarian Cancer
serious affected
5
serious at risk
15
other affected
15
other at risk
15
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG009
source section id
NCT02452424-ae
event group key
EG009
event group label
Dose Expansion: SCCHN
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-squamous-cell-carcinoma-docivyx-1bcd0a29
nct id
NCT02452424
harm key
EG010
source section id
NCT02452424-ae
event group key
EG010
event group label
Dose Expansion: GIST
serious affected
0
serious at risk
6
other affected
6
other at risk
6
frequency threshold
5
collection period
Adverse event data were collected for each subject from after the first dose was administered to 30 days after the last dose, through study completion at Cycle 16 (up to approximately 100 weeks)
event definition
Adverse events that emerge (or worsen) after the first dose of study drug and within 30 days after the last dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice