Trial Number

007-19

Age range

18 years and older

Gender

Female

Enrolling Patients

Yes

A major limitation of the current standard chemotherapy treatment for endometrial cancer is that most patients can only tolerate chemotherapy for a limited time due to associated toxicities and there are no approved maintenance treatment options available for patients with advanced endometrial cancer. This is compounded by the fact that there are currently no standard treatment options in the second-line setting or beyond, aside from salvage chemotherapy or participation in clinical trials. Further, the relative lack of development of new targeted therapies for endometrial cancer highlight the unmet need for patients with advanced endometrial cancer. In particular, new treatment options in the maintenance setting could build on the initial activity of carboplatin/paclitaxel, providing the potential to prolong the progression-free interval and the interval between lines of chemotherapy. This study was therefore designed to investigate whether durvalumab with or without olaparib would provide effective and safe maintenance therapy in patients with endometrial cancer. This is a prospective randomised, double-blind, placebo-controlled, multicentre Phase III study evaluating the efficacy, safety, and patient reported outcomes of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab with or without olaparib in patients with advanced or recurrent endometrial cancer compared to platinum-based chemotherapy (paclitaxel and carboplatin).

Principal Investigator

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