Trial Outcomes & Findings for Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer (NCT NCT03367741)
NCT ID: NCT03367741
Last Updated: 2026-05-19
Results Overview
PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
82 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2026-05-19
Participant Flow
59 were randomized. 5 participants were terminated/ withdrawn for reasons as late determination of ineligibility. 54 (36+18) from arms A and B were analyzed for primary endpoint (PFS). Rest 23 were part of Arm C (Exploratory cohort) and were not part of statistical analysis.
Participant milestones
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
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
|
Arm B (Nivolumab)
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
|
Arm C (Exploratory Cohort)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
20
|
23
|
|
Overall Study
COMPLETED
|
36
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
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
|
Arm B (Nivolumab)
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
|
Arm C (Exploratory Cohort)
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.
|
|---|---|---|---|
|
Overall Study
Late determination of ineligibility
|
3
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 Participants
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
|
Arm B (Nivolumab)
n=18 Participants
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
|
Arm C (Exploratory Cohort)
n=23 Participants
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.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
67 years
n=36 Participants
|
66 years
n=18 Participants
|
62 years
n=23 Participants
|
66.5 years
n=77 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=36 Participants
|
18 Participants
n=18 Participants
|
23 Participants
n=23 Participants
|
77 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=36 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Arm C participants were not evaluated as this was an exploratory cohort.
PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.
Outcome measures
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 Participants
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
|
Arm B (Nivolumab)
n=18 Participants
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
|
Arm C (Exploratory Cohort)
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.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
5.3 months
Interval 3.5 to 9.2
|
1.9 months
Interval 1.6 to 3.4
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
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.
Outcome measures
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 Participants
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
|
Arm B (Nivolumab)
n=18 Participants
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
|
Arm C (Exploratory Cohort)
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.
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
25 Percentage
|
11 Percentage
|
—
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: Pre-specified to only evaluate participants in Arm A and B; as Arm C was an exploratory cohort.
Survival estimates will be computed using the Kaplan-Meier method.
Outcome measures
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 Participants
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
|
Arm B (Nivolumab)
n=18 Participants
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
|
Arm C (Exploratory Cohort)
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.
|
|---|---|---|---|
|
Overall Survival (OS)
|
13 months
Interval 10.2 to 18.4
|
7.9 months
Interval 6.1 to
insufficient number of participants with events
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearFrequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
Outcome measures
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 Participants
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
|
Arm B (Nivolumab)
n=18 Participants
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
|
Arm C (Exploratory Cohort)
n=23 Participants
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.
|
|---|---|---|---|
|
Incidence of Adverse Events
|
11 participants
|
0 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearCorrelated 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.
Outcome measures
Outcome data not reported
Adverse Events
Arm A (Cabozantinib S-malate, Nivolumab)
Serious events: 11 serious events
Other events: 32 other events
Deaths: 25 deaths
Arm B (Nivolumab)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 13 deaths
Arm C (Exploratory Cohort)
Serious events: 10 serious events
Other events: 23 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 participants at risk
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
|
Arm B (Nivolumab)
n=18 participants at risk
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
|
Arm C (Exploratory Cohort)
n=23 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
3/36 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
0.00%
0/18 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
39.1%
9/23 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
|
Hepatobiliary disorders
Liver enzymes elevation
|
5.6%
2/36 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
0.00%
0/18 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
4.3%
1/23 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
|
Cardiac disorders
Hypertension
|
16.7%
6/36 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
0.00%
0/18 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
0.00%
0/23 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
Other adverse events
| Measure |
Arm A (Cabozantinib S-malate, Nivolumab)
n=36 participants at risk
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
|
Arm B (Nivolumab)
n=18 participants at risk
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
|
Arm C (Exploratory Cohort)
n=23 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
88.9%
32/36 • Number of events 32 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
66.7%
12/18 • Number of events 12 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
100.0%
23/23 • 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.
Adverse events were assessed in all three arms (A, B and C)
|
Additional Information
Dr. Stephanie Lheureux
University Health Network- Princess Margaret Cancer Centre
Phone: 416-946-2818
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60