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VEGF Inhibitor

Triple Combination Immunotherapy for Ovarian Cancer

Phase 2
Waitlist Available
Led By Jung-min Lee
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a CA125 >= 2 x upper limit of normal [ULN])
Toxicities of prior therapy (excepting alopecia and vitiligo), should be resolved to less than or equal to grade 1 as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study entry to date of death from any cause, assessed up to 5 years
Awards & highlights

Study Summary

This trial is studying the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer.

Who is the study for?
This trial is for women with certain types of ovarian, fallopian tube, or peritoneal cancer that has returned after platinum therapy. Participants must have had at least two prior treatments and can have had bevacizumab, PARP inhibitors, or immune checkpoint blockade. They should not have primary platinum-refractory disease or a history of severe bowel issues within the last 3 months.Check my eligibility
What is being tested?
The study compares combinations of durvalumab (an immunotherapy), olaparib (a PARP inhibitor), and cediranib (a drug blocking tumor growth) against standard treatments to see if they extend the time without cancer progression in patients with recurrent platinum-resistant ovarian-related cancers.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, infusion reactions from the drugs being administered into the bloodstream, fatigue, digestive problems like nausea and diarrhea, blood disorders such as anemia or clotting issues, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured by scans or has shown up in fluids with high CA125 levels.
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Side effects from my previous treatments are mild or gone, except for hair loss or skin color changes.
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My cancer is of a specific type and I have a known harmful BRCA1 or BRCA2 mutation.
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I have previously been treated with bevacizumab.
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I agree to use two forms of birth control.
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My cancer has been tested for BRCA mutations and hormone receptor status.
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I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study entry to date of death from any cause, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study entry to date of death from any cause, assessed up to 5 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
Secondary outcome measures
Duration of response
Incidence of adverse events
Objective response rate
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (cediranib maleate, olaparib)Experimental Treatment7 Interventions
Patients receive cediranib maleate PO QD on days 1-28 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Group II: Arm III (durvalumab, cediranib maleate)Experimental Treatment8 Interventions
Patients receive durvalumab IV over 60 minutes on day 1 and cediranib maleate PO QD Monday through Friday. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Group III: Arm II (durvalumab, cediranib maleate, olaparib)Experimental Treatment9 Interventions
Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate PO QD Monday through Friday, and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Group IV: Arm I (paclitaxel, doxorubicin, topotecan hydrochloride))Active Control9 Interventions
Patients receive paclitaxel IV over 60 minutes on days 1, 8, and 15, or pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1, or topotecan hydrochloride IV over 30 minutes on days 1, 8 and 15 or days 1-5 per the discretion of the treating physician. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo ECHO or MUGA during screening and as clinically indicated on study. Patients also undergo collection of blood and CT with contrast during screening, and CT or MRI scans throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Echocardiography
2013
Completed Phase 4
~11670
Biospecimen Collection
2004
Completed Phase 2
~1730
Cediranib Maleate
2010
Completed Phase 2
~660
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,338 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,703 Total Patients Enrolled
2 Trials studying Fallopian Tube Carcinoma
621 Patients Enrolled for Fallopian Tube Carcinoma
Jung-min LeePrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
562 Total Patients Enrolled

Media Library

Cediranib Maleate (VEGF Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04739800 — Phase 2
Fallopian Tube Carcinoma Clinical Trial 2023: Cediranib Maleate Highlights & Side Effects. Trial Name: NCT04739800 — Phase 2
Cediranib Maleate (VEGF Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04739800 — Phase 2

Frequently Asked Questions

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

Are there any other experiments that have explored the use of Durvalumab?

"Durvalumab first surfaced in an experiment conducted at Butterworth Campus of Spectrum Health Hospital back in 1997, and since then 2151 trials have been completed. Presently, 1591 different studies are actively recruiting participants with a substantial number located near Clackamas, Oregon."

Answered by AI

To what extent is the participation of patients being sought for this experiment?

"Affirmative. According to clinicaltrials.gov, the research trial which launched on April 28th 2021 is recruiting for 164 participants at 100 different sites. It has been updated as recently as November 23rd 2022."

Answered by AI

To what types of illnesses is Durvalumab typically administered?

"Durvalumab is commonly prescribed for typhus, yet it can be beneficial to those suffering from kaposi's sarcoma AIDS related, helicobacter pylori infection, and even endometritis."

Answered by AI

How many medical institutions are currently hosting this trial?

"This research trial is recruiting from a total of 100 medical centres, including the Providence Cancer Institute Clackamas Clinic in Clackamas, Northwell Health Imbert Cancer Center in Bay Shore, and Saint Alphonsus Medical Center-Nampa in Nampa."

Answered by AI

What potential risks have been identified for individuals taking Durvalumab?

"Due to the lack of efficacy data, Durvalumab's safety was appraised with a rating of 2 on our team's scale. This is because phase 2 trials are yet to generate evidence suggesting its effectiveness."

Answered by AI

Are more participants being sought for this research endeavor?

"This clinical trial is actively seeking participants, as evidenced by its listing on the clinicaltrials.gov website. It was first posted to the site in April 2021 and has been updated most recently in November 2022."

Answered by AI

Is this clinical trial a pioneering endeavor?

"Durvalumab has been researched for over two decades, beginning with its initial trial organised by Alfacell in 1997. After the successful completion of that first study, it achieved Phase 3 drug approval and is now present in 1591 active trials across 81 nations located within 3553 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
2021. "Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04739800.
~39 spots leftby Apr 2025
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