A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial Cancer.

Purpose

This randomized phase II trial studies how well cabozantinib and nivolumab work in treating patients with endometrial that has come back or spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and nivolumab may work better in treating endometrial cancer.

PRIMARY OBJECTIVES:

I. To evaluate the clinical anti-tumor activity of XL184 (cabozantinib) and nivolumab based on progression free survival (PFS) in patients with advanced, recurrent or metastatic endometrial cancer previously treated with at least one line of platinum-based chemotherapy compared to patients receiving nivolumab alone.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of XL184 and nivolumab in terms of overall response rate (ORR) compared to nivolumab alone.

II. To evaluate overall survival (OS) of patients receiving XL184 and nivolumab compared to patients receiving nivolumab alone.

III. To evaluate the safety of combination treatment using XL184 and nivolumab in patients with advanced, recurrent metastatic endometrial cancer.

IV. To evaluate correlation between PD-L1 expression, CD3, CD4 and CD8 infiltrates and outcome (PFS, ORR, OS).

V. To compare PD-L1 expression, CD3, CD4 and CD8 infiltrates in the primary tumor (archival tissue) and in the tissue from baseline biopsy.

VI. To assess activity (PFS, ORR and OS) of nivolumab alone or in combination with XL184 according to microsatellite instability (MSI)/mismatched repair (MMR) status.

Age

18 to 65
65 and over

Gender

N/A

Monetary compensation

No

Can be done from home

No

Keywords

Cabozantinib, Nivolumab

Principal Investigator

Merry Jennifer Markham, MD

Sponsoring Group

Department of Medicine

Department

Department of Medicine

Contact Information

merry.markham@medicine.ufl.edu

352.265.0725


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