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

  • STATUS
    Recruiting
  • End date
    Nov 14, 2025
  • participants needed
    1254
  • sponsor
    AstraZeneca
Updated on 19 November 2020
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (0.7 mi away) Contact
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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.

Description

Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fdration Internationale de Gyncologie et d'Obsttrique [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.

Details
Treatment bevacizumab, durvalumab, olaparib, Placebo olaparib, Durvalumab placebo, Carboplatin+Paclitaxel
Clinical Study IdentifierNCT03737643
SponsorAstraZeneca
Last Modified on19 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 150 yrs?
Are you female?
Do you have Advanced Ovarian Cancer?
Do you have any of these conditions: Do you have Advanced Ovarian Cancer??
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

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
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