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Clinical Trials in Italy / NCT03737643
Active, not recruiting Phase 3

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

NCT03737643 · tracked via the Priya Life Science Italy tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2019-01-04
Last updated
2026-07-07

Condition(s) studied

Advanced Ovarian Cancer

Investigational drug(s) / intervention(s)

Bevacizumab →Durvalumab →Olaparib →Placebo olaparibDurvalumab placeboCarboplatin+PaclitaxelAll Carboplatin trials (585) →All Paclitaxel trials (422) →

Bevacizumab: Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.

Durvalumab: Durvalumab by intravenous infusion

Olaparib: Olaparib tablets

Placebo olaparib: Placebo tablets to match olaparib

Durvalumab placebo: Matching placebo for intravenous infusion

Carboplatin+Paclitaxel: Standard of care chemotherapy

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set — At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
    To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
  • Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive) — At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
    To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer. Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.

Trial sites (214)

FacilityCityRegionStatus
Research Site Foothill Ranch California
Research Site Los Angeles California
Research Site Orange California
Research Site San Francisco California
Research Site Tampa Florida
Research Site Augusta Georgia
Research Site Hinsdale Illinois
Research Site Indianapolis Indiana
Research Site Towson Maryland
Research Site Detroit Michigan
Research Site Springfield Missouri
Research Site Middletown New Jersey
Research Site Montvale New Jersey
Research Site Albany New York
Research Site New York New York
Research Site Uniondale New York
Research Site Durham North Carolina
Research Site Cleveland Ohio
Research Site Dayton Ohio
Research Site Hilliard Ohio
Research Site Tulsa Oklahoma
Research Site Lancaster Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Salt Lake City Utah
Research Site Graz Austria
Research Site Innsbruck Austria
Research Site Linz Austria
Research Site Vienna Austria
Research Site Aalst Belgium
Research Site Leuven Belgium
Research Site Namur Belgium
Research Site Ostend Belgium
Research Site Sint-Niklaas Belgium
Research Site Barretos Brazil
Research Site Florianópolis Brazil
Research Site Fortaleza Brazil
Research Site Londrina Brazil
Research Site Porto Alegre Brazil

+ 174 more sites — see the full list on the official registry below.

On this site

📄 Avastin (bevacizumab) drug profile → 📄 Imfinzi (durvalumab) drug profile → 📄 Lynparza (olaparib) drug profile →

More AstraZeneca trials in Italy

PASS of Paediatric Patients Initiating Selumetinib Active, not recruiting
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer Recruiting
Acalabrutinib Real World Italian obSErvational Study -ARISE Active, not recruiting
Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

Centralization and Oncologic Outcomes in Ovarian Cancer Recruiting
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03737643 on ClinicalTrials.gov ↗ ← All trials in Italy