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Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer — DOVACC  

Ovarian Cancer Clinical Trial

Official title:
A Randomized Clinical Trial Investigating Olaparib, Durvalumab (MEDI4736) and UV1 as Maintenance Therapy in BRCAwt Patients With Recurrent Ovarian Cancer

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04742075
Study type Interventional
Source Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Contact Mansoor R. Mirza, MD
Phone 004535459624
Email mansoor.raza.mirza@regionh.dk
Status Recruiting
Phase Phase 2
Start date December 15, 2021
Completion date December 15, 2026
View Details
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