Finding studies
Finding studies
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Lead
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
With
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
