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Clinical Trial 20529
Cancer Type: Gynecological Tumor
Study Type: Treatment
NCT#: NCT04269200
Phase: Phase III
Prinicipal Investigator: Hye Sook Chon
Study Title
A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)
Summary
This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.
Objective
Primary Objective: To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy(paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) compared to platinum-based chemotherapy (Arm A) by assessment of progression-free survival (PFS), in patients with newly diagnosed advanced or recurrent endometrial cancer Secondary Objectives: To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab in combination with olaparib (Arm C) when compared to platinum-based chemotherapy (Arm A) by assessment of PFS in patients with newly diagnosed advanced or recurrent endometrial cancer To determine the efficacy of durvalumab in combination with platinum-based chemotherapy(paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of: PFS2, OS, ORR, DoR, TFST, TSST, and TDT To characterise the PK and immunogenicity of durvalumab and durvalumab in combination with olaparib To determine effects on symptoms, functioning and overall health-related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab (Arm B) or durvalumab with olaparib (Arm C) when compared to platinum-based chemotherapy alone (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients Safety Objective: To evaluate the safety and tolerability of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin)followed by maintenance durvalumab (Arm B)or durvalumab with olaparib (Arm C) compared to platinum-based chemotherapy (Arm A) in newly diagnosed advanced or recurrent endometrial cancer patients
Therapies
Medications
AMP-514 (Durvalumab); Durvalumab (); MEDI4736 (Durvalumab); Olaparib (Lynparza); Paraplatin (carboplatin); Placebo (); Taxol (paclitaxel); carboplatin (); paclitaxel ()
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