Cabozantinib S-malate and Nivolumab in Treating Patients With Advanced, Recurrent, or Metastatic Endometrial Cancer
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT03367741
- Phase
- PHASE2
- Status
- Active Not Recruiting
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
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biopsy Procedure — PROCEDUREUndergo tumor biopsy
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
- Cabozantinib S-malate — DRUGGiven PO
- Computed Tomography — PROCEDUREUndergo CT scan
- Magnetic Resonance Imaging — PROCEDUREUndergo MRI
- Nivolumab — BIOLOGICALGiven IV
Study Details
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.
Key Dates
- Start date
- Apr 16, 2018
- Status verified
- Jan 2026
- Primary completion
- May 9, 2025
- Completion
- Jul 23, 2026
Study Design
- Enrollment
- 82 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 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.
- Experimental: 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.
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: Up to 1 year ]
Locations (33)
Related coverage on Hipa.ai
- Nivolumab/Cabozantinib Combo Improves PFS, OS in Endometrial CancerNivolumab · Apr 29, 2026 · ClinicalTrials.gov
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