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

NCT03367741 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2026-05-19

Study results available
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Summary

This randomized phase II trial studies how well cabozantinib s-malate and nivolumab work in treating patients with endometrial cancer that has come back (recurrent) or spread to other places in the body (advanced or metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating endometrial cancer.

Conditions

  • Advanced Endometrial Carcinoma
  • Metastatic Endometrial Carcinoma
  • Recurrent Endometrial Carcinoma
  • Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
  • Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cabozantinib S-malate

Given PO

PROCEDURE

Computed Tomography

Undergo CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Stephanie Lheureux · University Health Network Princess Margaret Cancer Center LAO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2025-05-09
Completion
2026-07-23
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367741 on ClinicalTrials.gov