BridgeMD
This is a phase III randomised, double-blind, placebo-controlled, multicentre, global study to assess the effectiveness and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance therapy of bevacizumab either alone, or in combination with durvalumab, or in combination with durvalumab and olaparib in patients newly diagnosed with advanced ovarian cancer.
EU CTIS ID: 2022-502747-35-00
What this study is testing
To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of non-tBRCAm HRD positive patients and all non-tBRCAm patients with newly diagnosed advanced ovarian cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serous, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer
- Patients must be aged ≥18 years of age
- All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
- Mandatory provision of tumour sample for centralised tBRCA testing
- Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
- ECOG performance status 0-1
You likely can't join if
- Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology
- Prior systemic anti-cancer therapy for ovarian cancer
- Prior treatment with PARP inhibitor or immune mediated therapy
- Planned intraperitoneal cytotoxic chemotherapy
- Active or prior documented autoimmune or inflammatory disorders
- Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
See the full eligibility criteria
- Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serous, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer
- Patients must be aged ≥18 years of age
- All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
- Mandatory provision of tumour sample for centralised tBRCA testing
- Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
- ECOG performance status 0-1
- Patients must have preserved organ and bone marrow function
- Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test
- Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology
- Prior systemic anti-cancer therapy for ovarian cancer
- Prior treatment with PARP inhibitor or immune mediated therapy
- Planned intraperitoneal cytotoxic chemotherapy
- Active or prior documented autoimmune or inflammatory disorders
- Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
- Clinically significant cardiovascular disease
- History of another primary malignancy except for - Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease) - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated carcinoma in situ without evidence of disease - Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Canada
- China
- Japan
- Brazil
- Korea, Republic of
- Peru
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Canada; China; Japan; Brazil; Korea, Republic of and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.