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

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.

Timeline

Start

2018-04-16

Primary completion

2025-05-09

Completion

2026-07-23

Outcome

Met primary endpoint

paper months in Arm B (n=18) (HR=0.59, 90% CI 0.35 to 0.98; log-rank p=0.09, meeting the prespecified statistical significance criteria). PMID 35288469 ↗

Publications

• Lheureux S, Matei DE, Konstantinopoulos PA, Wang BX, Gadalla R, Block MS, Jewell A, Gaillard SL, McHale M, McCourt C, Temkin S, Girda E, Backes FJ, Werner TL, Duska L, Kehoe S, Colombo I, Wang L, Li X, Wildman R, Soleimani S, Lien S, Wright J, Pugh T, Ohashi PS, Brooks DG, Fleming GF. Translational randomized phase II trial of cabozantinib in combination with nivolumab in advanced, recurrent, or metastatic endometrial cancer. J Immunother Cancer. 2022 Mar;10(3):e004233. doi: 10.1136/jitc-2021-004233.

Drugs

Indications