Clinical trial · Interventional
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin+Paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| Durvalumab placebo | Drug | — | UNRESOLVED |
| Olaparib | Drug | Olaparib | ALIAS |
| Placebo olaparib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1
- description
- Platinum-based chemotherapy in combination with bevacizumab and durvalumab placebo (saline IV infusion) followed by maintenance bevacizumab, durvalumab placebo (saline IV infusion) and olaparib placebo (tablets).
- interventionNames
- Drug: Bevacizumab
- Drug: Placebo olaparib
- Drug: Durvalumab placebo
- Drug: Carboplatin+Paclitaxel
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.
- interventionNames
- Drug: Bevacizumab
- Drug: Durvalumab
- Drug: Placebo olaparib
- Drug: Carboplatin+Paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Key Inclusion Criteria: Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, 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. For patients enrolled in Japan that are aged \<20 year * All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery * Evidence of presence or absence of BRCA1/2 mutation in tumour tissue * Mandatory provision of tumour sample for centralised tBRCA testing * 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 Key Exclusion Criteria: Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology * Prior systemic anti-cancer therapy for ovarian cancer * Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation * 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 * Patients with known brain metastases * 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 * Persistent toxicities CTCAE Grade \>2 caused by previous cancer therapy * Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination/comparator agents * Breast feeding women
References
Publications (1)
- DERIVEDGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961