A Phase IIIB study to evaluate the use of durvalumab in combination with platinum-based chemotherapy followed by durvalumab with olaparib as first-line treatment in Patients with Newly Diagnosed pMMR Advanced or Recurrent Endometrial Cancer in Spain. DUoENDE Study

Advanced or recurrent endometrial cancer

Frequency of AEs that lead to treatment dose changes, temporary interruptions, or permanent discontinuation, Frequency of Immune-mediated adverse events1 (imAEs)., Frequency of grade ≥3 AEs. [Timeframe: 12 months after LSI]

Progression Free Survival (PFS) defined as the time from the date of first dose of treatment2 until the date of objective disease progression or death (by any cause in the absence of progression). The measure of interest is the median PFS., Objective Response Rate (ORR) using site investigator assessments according to RECIST 1.1., Duration of Response (DoR) defined as the time from the date of first documented response (which is subsequently confirmed) until date of documented progression or death in the absence of disease progression. The measure of interest is the median DoR., Overall Survival (OS) defined as the time from the date of first dose of treatment2 until death from any cause. The measure of interest is the median OS., Change from baseline in score on EORTC QLQ-C30 and EORTC QLQ-EN24 reported at enrollment and then throughout the prospective study follow-up to end of study treatment: every 12 weeks, at the end of treatment and at progression if the EOT is other reason than progression, Percentage of patients having clinically meaningful deterioration (i.e., absolute change in the score from baseline of ≥10) at 6, 12, 24 and 36 months after LSI.

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