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Angiogenesis Inhibitor

Durvalumab + Olaparib + Cediranib for Ovarian Cancer

Phase 1 & 2

Recruiting

Led By Jung-Min Lee, M.D.

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

Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications

Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC)

Must not have

Patients who have received prior PARPi

Patients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 days 1 and 15; cycles 2 and beyond day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the combination of Durvalumab, Olaparib, and Cediranib in adults with advanced or recurrent ovarian cancer to see how well they tolerate it and if it is effective in treating the cancer.

Who is the study for?

Adults with certain advanced cancers (ovarian, triple negative breast, lung, prostate and colorectal) that have progressed despite previous treatments. Participants must be over 18 years old with controlled blood pressure and no history of autoimmune diseases requiring steroids or primary immunodeficiency. They should not have had prior treatment with the drugs being tested in this trial or other similar immune therapies.

What is being tested?

The study is testing a combination of Durvalumab (an immune system booster), Olaparib (a DNA damage inhibitor), and Cediranib (a drug that halts blood vessel growth in cancer cells). The Phase I part checks for safety and tolerability while Phase II assesses effectiveness against ovarian cancer specifically.

What are the potential side effects?

Potential side effects include immune-related reactions affecting organs, high blood pressure from Cediranib, fatigue, nausea from Olaparib, as well as risks associated with taking Durvalumab such as infusion reactions. Regular monitoring through visits and diaries will help manage these.

Eligibility Criteria

Inclusion Criteria

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

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My blood pressure is under control with up to three medications.

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My prostate cancer has spread and is not responding to hormone therapy.

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My ovarian, fallopian tube, or peritoneal cancer has come back or didn't respond to treatment, including at least two prior treatments or resistance to platinum-based therapy.

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My breast cancer is triple-negative and has come back or not gone away.

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I have advanced NSCLC and received platinum-based chemo or specific inhibitors due to my tumor's genetic features.

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I am 18 years old or older.

Exclusion Criteria

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

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I have previously been treated with PARP inhibitors.

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I have previously received treatments like MEDI4736 or other therapies targeting PD1, PD-L1, or CTLA4.

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I have had a stroke or a mini-stroke in the last year.

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I have had pneumonitis or interstitial lung disease before.

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I have been diagnosed with tuberculosis in the past.

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I have an autoimmune disease and need steroids to manage it, or I have a primary immunodeficiency.

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I have had brain metastasis or leptomeningeal disease in the last year.

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I have been treated with both olaparib and cediranib.

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I have had other types of cancer besides the one I am seeking treatment for.

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I am HIV-positive and currently on antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 days 1 and 15; cycles 2 and beyond day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 days 1 and 15; cycles 2 and beyond day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 days 1 and 15; cycles 2 and beyond day 1 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Ph I Determine the recommended phase II dose (RP2D) and the safety of doublet therapies of Durvalumab/olaparib (Durvalumab-O) and Durvalumab/cediranib (Durvalumab-C) in patients with advanced solid tumors

Ph II Determine overall response rate of Durvalumab-O and Durvalumab-C in patients with recurrent ovarian cancer

Secondary study objectives

Therapeutic procedure

Ph I doublet tx: determine the safety of the doublets, Durvalumab+O and Durvalumab+C

Ph I doublet tx: explore changes in peripheral immune subsets, plasma cytokines and circulating endothelial cells with safety and/or clinical outcome of Durvalumab+C

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