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Monoclonal Antibodies

Combination Therapy for Ovarian Cancer (DUO-O Trial)

Q: What goals does this research hope to achieve?

<p>The aim of this long-running clinical trial is to study the impact of durvalumab on progression-free survival (PFS) in non-tBRCA HRD positive patients. Additionally, researchers will investigate if there is an increased benefit for tBRCAm patients and look at objective response rates (ORR) in non-tBRCAm patients.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 7 years

Awards & highlights

DUO-O 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.Check my eligibility

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.See study design

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.

DUO-O Trial 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.

DUO-O Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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 outcome measures

Safety and tolerability of drugs by assessment of AEs/SAEs

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

bradycardia

pneumonia

pyelonephritis

colon cancer

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

DUO-O 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

~5280

Durvalumab

2017

Completed Phase 2

~3870

Olaparib

2007

Completed Phase 4

~2140

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,253 Previous Clinical Trials

288,536,776 Total Patients Enrolled

48 Trials studying Ovarian Cancer

23,850 Patients Enrolled for Ovarian Cancer

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER

35 Previous Clinical Trials

15,232 Total Patients Enrolled

10 Trials studying Ovarian Cancer

4,791 Patients Enrolled for Ovarian Cancer

GOG Foundation, Inc. (GOG Foundation)UNKNOWN

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03737643 — Phase 3

Ovarian Cancer Research Study Groups: Arm 1, Arm 2, Arm 3, tBRCAm cohort

Ovarian Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03737643 — Phase 3

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03737643 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients being accepted for this research project at present?

"The trial, which was last updated on October 5th, 2022 and originally posted on January 4th, 2019 according to clinicaltrials.gov, is currently looking for participants."

Answered by AI

Does this research involve people who are over 40 years old?

"In order to be included in this trial, patients must between the ages of 18-130. There are 129 other trials for those under 18 and 2371 for people 65 and older."

Answered by AI

For what sorts of medical conditions is Bevacizumab typically prescribed?

"Bevacizumab is frequently used to treat malignant neoplasms, but it can also be useful in treating locally advanced nonsquamous non-small cell lung cancer, metastatic colorectal cancer (crc), and as part of a conditioning regimen for allogeneic stem cell transplantation therapy."

Answered by AI

Has Bevacizumab been cleared for use in the United States?

"According to our assessment, Bevacizumab ranks as a 3 in terms of safety. This is because it has reached Phase 3 clinical trials, meaning that there is both supportive efficacy data and multiple rounds worth of data affirming its safety."

Answered by AI

What are the prerequisites for participating in this clinical trial?

"This study is accepting 1374 patients with ovary cancer aged 18 and 130. Most notable, applicants should meet the following criteria: Patients must be aged ≥18 years of age. For patients enrolled in Japan that are aged <20 year, 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, All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan"

Answered by AI

What goals does this research hope to achieve?

"The aim of this long-running clinical trial is to study the impact of durvalumab on progression-free survival (PFS) in non-tBRCA HRD positive patients. Additionally, researchers will investigate if there is an increased benefit for tBRCAm patients and look at objective response rates (ORR) in non-tBRCAm patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737643.

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