STUDY DESIGN This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.~Number of total subjects to be included in the trial:~184 patients will be enrolled in the study.~Patients are randomized into one of the three treatment arms, (A:B:C), in a 1:1:2 randomization:~Arm A (olaparib): 46 subjects~Arm B (olaparib plus durvalumab): 46 subjects~Arm C (olaparib plus durvalumab plus UV1): 92 subjects~Patients are stratified according to:~HRD status~Previous use of PARP inhibitor (yes/no)~Primary objective:~• To compare the preliminary efficacy of maintenance treatment with olaparib (arm A) to that of olaparib plus durvalumab and UV1 (arm C)~Secondary objectives:~To compare the preliminary efficacy of maintenance treatment with olaparib plus durvalumab (arm B) to that of olaparib plus durvalumab and UV1 (arm C)~To compare the preliminary efficacy of maintenance treatment with olaparib plus durvalumab to that of olaparib plus durvalumab and UV1 according to stratification factors~To evaluate Patient Reported Outcomes (PROs) in treatment arms~To compare the preliminary efficacy of maintenance treatment according to PD-L1 status~To evaluate safety in treatment arms~Exploratory objectives:~To describe genetic, molecular, and immunological mechanisms in blood and tumor of maintenance treatment.~To explore the efficacy of maintenance treatment in the molecular subgroups based on homologous recombination deficiency (HRD) status.
This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.