NCT04742075

Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Olaparib + durvalumab + UV1	The subjects are randomized 1:1:2 to receive treatment until progression of disease or untorable toxicity.

Timeline

• Start date: 2021-12-15
• Primary completion: 2026-05-01
• Completion: 2030-12-31
• First posted: 2021-02-05
• Last updated: 2026-02-27

Locations

1 site across 1 country: Denmark