Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients

Official Title

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

Summary:

This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS) - in non-tBRCA HRD positive patients
• Progression Free Survival (PFS) - in all non-tBRCA patients

Secondary Outcome:

• Progression Free Survival (PFS) - in non-tBRCAm patients
• Overall Survival (OS) - in non-tBRCA HRD positive patients and in all non-tBRCA patients
• Second Progression (PFS2) - in non-tBRCAm patients
• Health-related quality of life - in non-tBRCAm patients
• Pathological Complete Response (pCR) - in non-tBRCAm patients
• The pharmacokinetics (PK) and immunogenicity of durvalumab and olaparib as determined by peak concentration - in non-tBRCAm patients
• Objective Response Rate (ORR) - in non-tBRCAm patients
• Duration of response (DoR) - in non-tBRCAm patients
• Time to first subsequent therapy (TFST) - in non-tBRCAm patients
• Time to second subsequent therapy (TSST) - in non-tBRCAm patients
• Time to discontinuation or death (TDT) - in non-tBRCAm patients
• PFS - in tBRCAm patients
• PFS2 - in tBRCAm patients
• ORR - in tBRCAm patients
• ORR pre-surgery in IDS group - in tBRCAm patients
• Duration of response (DoR) - in tBRCAm patients
• Time to first subsequent therapy (TFST) - in tBRCAm patients
• Time to second subsequent therapy (TSST) - in tBRCAm patients
• Time to discontinuation or death (TDT) - in tBRCAm patients
• Health-related quality of life - in tBRCAm patients
• Proportion of patients with pCR in patients undergoing IDS - in tBRCAm patients

Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab.

The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.

View this trial on ClinicalTrials.gov