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Monoclonal Antibodies

Combination Therapy for Ovarian Cancer (DUO-O Trial)

Phase 3

Waitlist Available

Led By Philipp Harter

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test

Patients must have preserved organ and bone marrow function

Must not have

Non-epithelial ovarian cancer, borderline tumors, low grade epithelial tumors or mucinous histology

Active or prior documented autoimmune or inflammatory disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 7 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new combination of drugs for ovarian cancer. The goal is to see if it is more effective and has fewer side effects than the current standard of care.

Who is the study for?

This trial is for women over 18 with newly diagnosed advanced ovarian cancer, including certain subtypes and related cancers. They should be fit for surgery, have a performance status of 0-1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and not pregnant. Exclusions include autoimmune disorders, brain metastases, recent malignancies except specific treated cases, ongoing severe side effects from past treatments, cardiovascular disease, prior treatment for ovarian cancer or allergies to the study drugs.

What is being tested?

The study tests Durvalumab combined with chemotherapy (Carboplatin+Paclitaxel) and Bevacizumab versus placebo controls followed by maintenance therapy with Durvalumab and Bevacizumab alone or alongside Olaparib. It's a Phase III trial where patients are randomly assigned to different treatment groups without knowing which one they're receiving.

What are the potential side effects?

Possible side effects include immune-related reactions due to Durvalumab affecting organs like lungs or intestines; high blood pressure from Bevacizumab; bone marrow suppression causing low blood cell counts from chemotherapy; fatigue; nausea; potential allergic reactions to any drug components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am postmenopausal or not currently pregnant.

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My organs and bone marrow are functioning well.

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My tumor has been tested for BRCA1/2 mutations.

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I have advanced ovarian, peritoneal, or fallopian tube cancer.

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I can provide a tumor sample for BRCA testing.

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I am a candidate for surgery to remove as much of the cancer as possible.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ovarian cancer is not the common type, it's either borderline, low grade, or mucinous.

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I have or had an autoimmune or inflammatory disorder.

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My BRCA mutation status is unknown.

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I have brain metastases.

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I have previously been treated with a PARP inhibitor or immunotherapy.

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I have a serious health condition that is not under control.

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I have received systemic anti-cancer therapy for ovarian cancer.

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I have a serious heart condition.

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I am scheduled for chemotherapy that will be given directly into my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Duration of response (DoR) - in non-tBRCAm patients

Duration of response (DoR) - in tBRCAm patients

Health-related quality of life - in non-tBRCAm patients

+18 more

Other study objectives

Safety and tolerability of drugs by assessment of AEs/SAEs

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

52%

increased intraocular pressure

26%

worsening of cataract

15%

posterior capsule opacification

11%

vitreous syneresis

epiretinal membrane

vitreous hemorrhage

choroidal detachment

congestive heart failure

100%

80%

60%

40%

20%

Study treatment Arm

Ozurdex

Bevacizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: tBRCAm cohortExperimental Treatment4 Interventions

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.

Group II: Arm 3Experimental Treatment4 Interventions

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.

Group III: Arm 2Experimental Treatment4 Interventions

Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.

Group IV: Arm 1Active Control4 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Durvalumab

2017

Completed Phase 2

~3750