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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

Must not have

Active infection including tuberculosis, hepatitis B, or hepatitis C

Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to time of progression or death, whichever occurs first. median follow-up time was 4.8 months (inter-quartile range: 2.0-7.9 months).

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I do not have an active infection like TB, hepatitis B, or C.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I do not have any severe illnesses or social situations that would stop me from following the study rules.

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I am HIV positive.

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My heart health is good and I don't have major heart problems.

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My tests show signs of MDS or AML.

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I have had pneumonitis treated with steroids or have it now.

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My CA-125 levels are increasing but my cancer can't be measured using standard scans.

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My cancer got worse during my first platinum-based chemotherapy.

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I am allergic to medications similar to durvalumab, olaparib, or cediranib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of progression or death, whichever occurs first. median follow-up time was 4.8 months (inter-quartile range: 2.0-7.9 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of progression or death, whichever occurs first. median follow-up time was 4.8 months (inter-quartile range: 2.0-7.9 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression or death, whichever occurs first. median follow-up time was 4.8 months (inter-quartile range: 2.0-7.9 months). 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

Secondary study objectives

Count of Participants With a Grade 3 (or Higher) Adverse Event

Duration of Response

Objective Response Rate

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3750

Echocardiography

2013

Completed Phase 4

~11580