NCT03367741 · ADVERSE EVENTS

Adverse events

Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer · Source last updated 2026-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 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.
Other-event reporting threshold: 5%

Adverse events were assessed in all three arms (A, B and C)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	11 / 36	32 / 36	25 / 36
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	0 / 18	12 / 18	13 / 18
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.	10 / 23	23 / 23	18 / 23

Group identifiers: EG000: Arm A (Cabozantinib S-malate, Nivolumab) · EG001: Arm B (Nivolumab) · EG002: Arm C (Exploratory Cohort)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
9
num At Risk
23
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
1
num At Risk
23
term
Liver enzymes elevation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
0
num At Risk
23
term
Hypertension

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
32
num At Risk
36
num Events
32
group Id
EG001
num Affected
12
num At Risk
18
num Events
12
group Id
EG002
num Affected
23
num At Risk
23
term
Diarrhea

Complete source fields

description

Adverse events were assessed in all three arms (A, B and C)

event Groups

deaths Num Affected
25
deaths Num At Risk
36
description
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
id
EG000
other Num Affected
32
other Num At Risk
36
serious Num Affected
11
serious Num At Risk
36
title
Arm A (Cabozantinib S-malate, Nivolumab)
deaths Num Affected
13
deaths Num At Risk
18
description
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
id
EG001
other Num Affected
12
other Num At Risk
18
serious Num Affected
0
serious Num At Risk
18
title
Arm B (Nivolumab)
deaths Num Affected
18
deaths Num At Risk
23
description
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.
id
EG002
other Num Affected
23
other Num At Risk
23
serious Num Affected
10
serious Num At Risk
23
title
Arm C (Exploratory Cohort)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
32
num At Risk
36
num Events
32
group Id
EG001
num Affected
12
num At Risk
18
num Events
12
group Id
EG002
num Affected
23
num At Risk
23
term
Diarrhea

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
9
num At Risk
23
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
2
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
1
num At Risk
23
term
Liver enzymes elevation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
6
num At Risk
36
group Id
EG001
num Affected
0
num At Risk
18
group Id
EG002
num Affected
0
num At Risk
23
term
Hypertension

time Frame

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.

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Preserved source evidence · Not medical advice