NCT03367741 · STUDY IN CONTEXT

Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.

Arm C participants were not evaluated as this was an exploratory cohort.

→

secondary · POSTED

Summary statistics, such as mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum test may be substituted if necessary. 95% percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.

→

secondary · POSTED

Survival estimates will be computed using the Kaplan-Meier method.

Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.

→

secondary · POSTED

Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.

Source null

→

secondary · NOT_POSTED

Correlated with outcomes (PFS, ORR, OS). The log rank test, cox model or Chi-Square test will apply to access the association between PD-L1, CD3, CD4, CD8 expression and outcome (PFS, OS, ORR) where appropriate.

Source null

→

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-carcinosarcoma
nct id: NCT03367741
trial label: Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 5
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0000
source section id
NCT03367741-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.
time origin
Up to 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Arm C participants were not evaluated as this was an exploratory cohort.
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-carcinosarcoma
nct id
NCT03367741
outcome key
om-0001
source section id
NCT03367741-om-0001
source outcome index
1
endpoint
Overall Response Rate (ORR)
endpoint definition
Summary statistics, such as mean, median, counts and proportion, will be used to summarize the patients. Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Non-parametric tests such as Spearman correlation coefficients, Fisher's exact tests and Wilcoxon rank sum test may be substituted if necessary. 95% percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
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-carcinosarcoma
nct id
NCT03367741
outcome key
om-0002
source section id
NCT03367741-om-0002
source outcome index
2
endpoint
Overall Survival (OS)
endpoint definition
Survival estimates will be computed using the Kaplan-Meier method.
time origin
Up to 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
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-carcinosarcoma
nct id
NCT03367741
outcome key
om-0003
source section id
NCT03367741-om-0003
source outcome index
3
endpoint
Incidence of Adverse Events
endpoint definition
Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-carcinosarcoma
nct id
NCT03367741
outcome key
om-0004
source section id
NCT03367741-om-0004
source outcome index
4
endpoint
PD-L1 Expression, CD3, CD4 and CD8 Analysis
endpoint definition
Correlated with outcomes (PFS, ORR, OS). The log rank test, cox model or Chi-Square test will apply to access the association between PD-L1, CD3, CD4, CD8 expression and outcome (PFS, OS, ORR) where appropriate.
time origin
Up to 1 year
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
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-carcinosarcoma
nct id
NCT03367741
outcome key
om-0000
arm key
OG000
arm label
Arm A (Cabozantinib S-malate, Nivolumab)
regimen
Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0000
arm key
OG001
arm label
Arm B (Nivolumab)
regimen
Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0000
arm key
OG002
arm label
Arm C (Exploratory Cohort)
regimen
Patients with diagnosis of endometrial carcinosarcoma will be enrolled in the exploratory cohort (arm C) receiving combination of cabozantinib and nivolumab and will not be part of the statistical analysis.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0001
arm key
OG000
arm label
Arm A (Cabozantinib S-malate, Nivolumab)
regimen
Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0001
arm key
OG001
arm label
Arm B (Nivolumab)
regimen
Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0002
arm key
OG000
arm label
Arm A (Cabozantinib S-malate, Nivolumab)
regimen
Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0002
arm key
OG001
arm label
Arm B (Nivolumab)
regimen
Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0003
arm key
OG000
arm label
Arm A (Cabozantinib S-malate, Nivolumab)
regimen
Patients receive cabozantinib s-malate PO QD on days 1-28 and nivolumab IV over 30 minutes on days 1 and 15, then on day 1 beginning cycle 5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0003
arm key
OG001
arm label
Arm B (Nivolumab)
regimen
Patients receive nivolumab as in Arm A. Patients may cross-over to Arm A at the time of disease progression. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, and blood sample collection throughout the study and undergo biopsy at screening and optionally at follow up. Biopsy Procedure: Undergo tumor biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT scan Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
outcome key
om-0003
arm key
OG002
arm label
Arm C (Exploratory Cohort)
regimen
Patients with diagnosis of endometrial carcinosarcoma will be enrolled in the exploratory cohort (arm C) receiving combination of cabozantinib and nivolumab and will not be part of the statistical analysis.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03367741-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-carcinosarcoma
nct id
NCT03367741
harm key
EG000
source section id
NCT03367741-ae
event group key
EG000
event group label
Arm A (Cabozantinib S-malate, Nivolumab)
serious affected
11
serious at risk
36
other affected
32
other at risk
36
frequency threshold
5
collection period
All-Cause Mortality was assessed up to 4 years. Adverse events assessed from beginning of protocol treatment till 30-37 days after last dose, an average of 1 year.
event definition
Adverse events were assessed in all three arms (A, B and C)
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-carcinosarcoma
nct id
NCT03367741
harm key
EG001
source section id
NCT03367741-ae
event group key
EG001
event group label
Arm B (Nivolumab)
serious affected
0
serious at risk
18
other affected
12
other at risk
18
frequency threshold
5
collection period
All-Cause Mortality was assessed up to 4 years. Adverse events assessed from beginning of protocol treatment till 30-37 days after last dose, an average of 1 year.
event definition
Adverse events were assessed in all three arms (A, B and C)
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-carcinosarcoma
nct id
NCT03367741
harm key
EG002
source section id
NCT03367741-ae
event group key
EG002
event group label
Arm C (Exploratory Cohort)
serious affected
10
serious at risk
23
other affected
23
other at risk
23
frequency threshold
5
collection period
All-Cause Mortality was assessed up to 4 years. Adverse events assessed from beginning of protocol treatment till 30-37 days after last dose, an average of 1 year.
event definition
Adverse events were assessed in all three arms (A, B and C)
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