Participant flow

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.

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

   FG000

   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

   FG001

   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

   FG002

   title

   Arm C (Exploratory Cohort)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Late determination of ineligibility

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         20

      3. group Id

         FG002

         num Subjects

         23

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         36

      2. group Id

         FG001

         num Subjects

         18

      3. group Id

         FG002

         num Subjects

         23

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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.

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Preserved source evidence · Not medical advice