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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 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
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: P2 Durvalumab+O+CExperimental Treatment3 Interventions
Ph II Durvalumab + olaparib + cediranib at RP2D
Group II: P2 Durvalumab+OExperimental Treatment2 Interventions
Ph II Durvalumab + olaparib at RP2D
Group III: P2 Durvalumab+CExperimental Treatment2 Interventions
Ph II Durvalumab + cediranib at RP2D
Group IV: P1 Durvalumab+O+CExperimental Treatment3 Interventions
Ph I Durvalumab + olaparib + cediranib dose escalation
Group V: P1 Durvalumab+OExperimental Treatment2 Interventions
Ph I Durvalumab + olaparib dose escalation
Group VI: P1 Durvalumab+CExperimental Treatment2 Interventions
Ph I Durvalumab + cediranib dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cediranib
2016
Completed Phase 3
~4030
Durvalumab
2017
Completed Phase 2
~3750
Olaparib
2007
Completed Phase 4
~2190

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,016,415 Total Patients Enrolled
Jung-Min Lee, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
856 Total Patients Enrolled

Media Library

Cediranib (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02484404 — Phase 1 & 2
Cancer Research Study Groups: P2 Durvalumab+O, P2 Durvalumab+C, P2 Durvalumab+O+C, P1 Durvalumab+O+C, P1 Durvalumab+O, P1 Durvalumab+C
Cancer Clinical Trial 2023: Cediranib Highlights & Side Effects. Trial Name: NCT02484404 — Phase 1 & 2
Cediranib (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02484404 — Phase 1 & 2
~3 spots leftby Dec 2024
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