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NCT03367741 · OUTCOME

Progression Free Survival (PFS)

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Up to 1 year

What was measured

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

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

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Cabozantinib S-malate, Nivolumab)36
Arm B (Nivolumab)18
Arm C (Exploratory Cohort)0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Cabozantinib S-malate, Nivolumab)5.3Not reported3.59.2Not reported
Arm B (Nivolumab)1.9Not reported1.63.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.5
        upper Limit
        9.2
        value
        5.3
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        3.4
        value
        1.9
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      0
    units
    Participants
description
PFS is defined as the interval between randomization and disease progression or death from any cause, which ever occurred earlier.
dispersion Type
90% Confidence Interval
groups
  1. 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
    OG000
    title
    Arm A (Cabozantinib S-malate, Nivolumab)
  2. 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
    OG001
    title
    Arm B (Nivolumab)
  3. 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
    OG002
    title
    Arm C (Exploratory Cohort)
param Type
MEDIAN
population Description
Arm C participants were not evaluated as this was an exploratory cohort.
reporting Status
POSTED
time Frame
Up to 1 year
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice