A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer

Summary

This study will test the safety and efficacy of the experimental drug called durvalumab with or without another experimental drug called tremelimumab in endometrial cancer. Radiologic tumor assessment will be repeated every 8 weeks +/- 7 days for the first 48 weeks and then every 12 weeks +/- 7 days until PD. For patients who remain progression free 2 years post completion of protocol directed treatment, every 6 months +/- 1 month. irRECIST assessments will only be completed for patients continuing treatment beyond PD.

Timeline

Start

2017-01

Primary completion

2022-12-30

Completion

2022-12-30

Publications

• Di Dio C, Bogani G, Di Donato V, Cuccu I, Muzii L, Musacchio L, Scambia G, Lorusso D. The role of immunotherapy in advanced and recurrent MMR deficient and proficient endometrial carcinoma. Gynecol Oncol. 2023 Feb;169:27-33. doi: 10.1016/j.ygyno.2022.11.031. Epub 2022 Dec 6.
• Antill Y, Kok PS, Robledo K, Yip S, Cummins M, Smith D, Spurdle A, Barnes E, Lee YC, Friedlander M, Baron-Hay S, Shannon C, Coward J, Beale P, Goss G, Meniawy T, Lombard J, Andrews J, Stockler MR, Mileshkin L; Australia New Zealand Gynaecological Oncology Group (ANZGOG). Clinical activity of durvalumab for patients with advanced mismatch repair-deficient and repair-proficient endometrial cancer. A nonrandomized phase 2 clinical trial. J Immunother Cancer. 2021 Jun;9(6):e002255. doi: 10.1136/jitc-2020-002255.

Drugs

Indications