ClinicalTrials.gg
Active, not recruitingNCT03660826Updated Oct 22, 2026Results posted

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone

A Phase 2 interventional study of Biospecimen Collection and Bone Marrow Aspirate in Endometrial Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 761 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Updated Oct 22, 20262 sites added2 sites removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Carcinoma, Endometrioid by National Cancer Institute (NCI) — 2 open to participants now, 7 under way, none of them phase 3. Carcinoma, Endometrioid · National Cancer Institute (NCI).

Enrollment
2nd of 14
288 · median 84
Started
2018
with 2 others
Phase 2
9 of 14
2 open now
Registered
8th of 14
by date

Among the 14 studies in Carcinoma, Endometrioid by National Cancer Institute (NCI), this one is the 2nd largest by enrollment, is one of 3 that started in 2018, is one of 9 in phase 2, and was the 8th registered.

Carcinoma, Endometrioid

46 studies on the registry are indexed under Carcinoma, Endometrioid; 11 are open to participants now.

Browse Carcinoma, Endometrioid studies →

Open to participants now

2 of the 14 studies in Carcinoma, Endometrioid by National Cancer Institute (NCI) are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 11 Carcinoma, Endometrioid studies recruiting now, 8 (73%) set no upper age limit and 3 (27%) stop at 75 or younger; 3 take children under 18; 0 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

This phase II trial studies the effects of the combination of olaparib and durvalumab, cediranib and durvalumab, olaparib and capivasertib, and cediranib alone in treating patients with endometrial cancer that has come back (recurrent) or does not respond to treatment (refractory). Olaparib, cediranib, and capivasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Testing the combinations may lower the chance of endometrial cancer growing or spreading compared to usual care.

Read the detailed description

PRIMARY OBJECTIVES:

I. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.

II. To compare the efficacy of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.

SECONDARY OBJECTIVES:

I. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single-agent cediranib as measured by overall survival (OS) in patients with recurrent, persistent or metastatic endometrial cancer.

II. To compare the efficacy of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736) versus single agent cediranib as measured by overall survival (OS), in patients with recurrent, persistent or metastatic endometrial cancer.

III. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment versus single-agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.

IV. To compare the efficacy of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736) versus single agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.

V. To assess the safety and tolerability of single-agent cediranib, single-agent olaparib, and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment).

VI. To assess the safety and tolerability of the combination of olaparib and AZD5363 (capivasertib), and the combination of olaparib and durvalumab (MEDI4736), and the combination of cediranib and durvalumab (MEDI4736).

VII. To assess if mutations in deoxyribonucleic acid (DNA) homologous repair genes (assayed prior to all treatment and prior to the study treatment) are predictive of response to olaparib alone or in combination with cediranib. (Integrated Biomarker) VIII. To assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib. (Integrated Biomarker)

EXPLORATORY OBJECTIVE:

I. To compare the efficacy of the combination of olaparib and cediranib versus single agent olaparib as measured by PFS, response rate and OS, if and only if the combination is superior to the single-agent cediranib arm.

OUTLINE: Patients are randomized to 1 of 6 arms.

ARM I: Patients in reference group 1 receive cediranib maleate orally (PO) once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, computed tomography (CT), echocardiography (Echo) or multigated acquisition scan (MUGA) on study.

ARM II: Patients receive olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

ARM III: Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

ARM IV: Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

ARM V: Patients receive olaparib PO BID on days 1-28 and durvalumab intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

ARM VI: Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

ARM VII: Patients in reference group 1 receive cediranib maleate PO QD during 08/16/2021 - 06/28/2023). Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

03

Conditions studied

  • Endometrial Adenocarcinoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Undifferentiated Carcinoma
  • Endometrioid Adenocarcinoma
  • Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have recurrent or persistent endometrial carcinoma, which is to curative therapy or established treatments; histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.); NOTE: clear cell and carcinosarcoma histology is excluded.
  • Patients must have as defined by (RECIST) 1.1 or non-measurable (detectable) disease

    • Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI; patients with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST version 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a is obtained to confirm persistence at least 90 days following completion of radiation therapy
    • Non-measurable (detectable) disease in a patient is defined in this protocol as one who does not have measurable disease but has at least one of the following conditions:

      • Ascites and/or pleural effusion attributed to tumor;
      • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions.
  • Patients must have signed an approved and authorization permitting release of personal health information.
  • Patients must have had one prior chemotherapeutic regimen for management of endometrial carcinoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen.
  • Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition: cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa; Note: patients on this non-cytotoxic study are allowed to receive one additional cytotoxic chemotherapy regimen for management of recurrent or persistent disease, as defined above; however, patients are encouraged to enroll on non-cytotoxic studies prior to receiving additional cytotoxic therapy.
  • Patients may have received non cytotoxic therapy including immunotherapy (1 prior line in either upfront or recurrent setting) but excluding cediranib, olaparib, AZD5363 (capivasertib), durvalumab (MEDI4736), or the combination of lenvatinib and pembrolizumab for the management of recurrent or persistent disease; prior hormonal therapy is allowed; hormonal therapy for grade 1 endometrial cancers with low volume or indolent disease is encouraged.
  • Bevacizumab, or one course of single-agent immune-checkpoint therapy, excluding durvalumab (MEDI4736), is permitted prior to enrollment on this trial.
  • Body weight > 30 kg.
  • Age >= 18.
  • The trial is open to females only (including women with an intact uterus with uterine cancer); fertile females of need to agree to use adequate measures from 2 weeks prior to the study and until 1 month after study treatment discontinuation, and have a negative serum or urine pregnancy test within 3 days prior to the start of study treatment.
  • Patients must have an (ECOG) performance status of 0,1 or 2 ( >= 60%) within 7 days prior to registration; patients should have no deterioration over the previous two weeks.
  • >= 10 mg/dL with no blood transfusion in the past 28 days (within 28 days prior to administration of study drug).
  • count >= 100 x 10\^9/L (within 28 days prior to administration of study drug).
  • (ANC) >= 1.5 x 10\^9/L (within 28 days prior to administration of study drug).
  • Patients must have estimated of >= 51 mL/min using the Cockcroft Gault equation or based on a 24-hour urine test (within 28 days prior to administration of study drug).
  • Serum =\< 1.5 X (ULN) (within 28 days prior to administration of study drug).
  • (AST)/alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to administration of study drug).
  • Urinalysis (dipstick) =\< 1+ proteinuria OR urine protein creatinine ratio (UPCR) \< 1 (within 28 days prior to administration of study drug).
  • Patients must be able to swallow and retain oral medications and without gastrointestinal illnesses that would preclude absorption of cediranib, olaparib, or AZD5363 (capivasertib).
  • Patients must have adequately controlled blood pressure (BP), with a BP no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility; patients must have a BP of =\< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; patients with hypertension may be managed with up to a maximum of three antihypertensive medications; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or blood pressure specialist for management of blood pressure while on protocol.

    • Note: Patients must be willing and able to check and record daily blood pressure readings.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction.
  • or evidence of non-childbearing status for women of childbearing potential as confirmed by a negative urine or serum pregnancy test within 7 days prior to start of products (IPs); postmenopausal is defined as:

    • Age >= 60 years, or
    • Age \< 60 with any one or more of the conditions below:

      • Amenorrheic for >= 1 year in the absence of chemotherapy and/or hormonal treatments,
      • Luteinizing hormone and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range
      • Radiation-induced oophorectomy with last menses > 1 year ago,
      • Chemotherapy-induced menopause with > 1 year interval since last menses,
      • Surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Patients must have a of greater than 16 weeks.
  • Patients with a previous diagnosis of immune or inflammatory colitis or chronic diarrhea > 1 month without immune or inflammatory colitis are eligible with adequately controlled colitis (no diarrhea greater than grade 1 for at least 28 days) and in the absence of symptoms related to colonic dysfunction; patients who required for prior immune related colitis are not eligible.
  • Females of child-bearing potential should use two forms of highly reliable methods of contraception from the time of screening until 4 weeks after discontinuing study treatment.

    • Acceptable methods of contraception include:

      • Established use of oral, injected or implanted hormonal methods of contraception.
      • Placement of an intrauterine device or intrauterine system.
      • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
      • Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
      • True abstinence (i.e., not engaging in sexual activity for the total duration of study treatment and the treatment is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control).
      • Bilateral tubal occlusion or salpingectomy
    • Acceptable non-hormonal birth control methods include:

      • Total/True abstinence: When the patient refrains from any form of sexual intercourse and this is in line with their usual and/or preferred lifestyle; this must continue for the total duration of the trial and for at least 1 month after the last dose of study drug \<\<for 3 months after last dose for male patients>>. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, or declaration of abstinence solely for the duration of a trial) and withdrawal are not acceptable methods of contraception]
      • Vasectomised sexual partner PLUS male condom. With participant assurance that partner received post-vasectomy confirmation of azoospermia.
      • Tubal occlusion PLUS male condom
      • Intrauterine device (IUD) PLUS male condom. Provided coils are copper-banded.
    • Acceptable hormonal methods:

      • Normal and low dose combined oral pills PLUS male condom.
      • Cerazette (desogestrel) PLUS male condom. Cerazette is currently the only highly efficacious progesterone-based pill.
      • Hormonal shot or injection (e.g., Depo-Provera) PLUS male condom.
      • Etonogestrel implants (e.g., Implanon, Norplant) PLUS male condom.
      • Norelgestromin/EE transdermal system PLUS male condom
      • Intrauterine system [IUS] device (e.g., levonorgestrel releasing IUS -Mirena) PLUS male condom.
      • Intravaginal device (e.g., EE and etonogestrel) PLUS male condom.

Exclusion criteria

Exclusion Criteria:

  • Prior enrollment into a clinical trial including cediranib or olaparib; Note: prior bevacizumab is not an exclusion criterion.
  • Prior enrollment into a clinical trial including cediranib, olaparib, AZD5363 (capivasertib), durvalumab (MEDI4736), or the combination of lenvatinib and pembrolizumab. Note: Prior bevacizumab or single-agent immune checkpoint blockade, excluding durvalumab (MEDI4736), is not an exclusion criterion.
  • Prior chemotherapy, endocrine therapy, radiotherapy, or agents within 4 weeks.
  • More than one with immune checkpoint blockade therapy.
  • Current signs/symptoms of bowel obstruction and/or signs/symptoms of bowel obstruction within the preceding 3 months.
  • History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula.
  • Uncontrolled intercurrent illness including, but not limited to known ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or psychiatric illness/social situations that would limit compliance with study requirements.
  • Concomitant use of known strong cytochrome (CYP) 3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil); the required prior to starting study treatments is 2 weeks for strong inhibitors, and at least 1 week for moderate inhibitors.
  • Concomitant use of potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John's wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of study treatment. Concomitant use of drugs known to prolong the within 5 half-lives of the first dose of study treatment.
  • Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study; for women of childbearing capacity a negative pregnancy test is required.
  • Known (HIV)-positive individuals are ineligible because of the potential for pharmacokinetic interactions between many anti-HIV drugs and cediranib, olaparib, and/or AZD5363 (capivasertib); in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • Known active or infection on antiviral treatment.
  • Prior history of stroke or within the last 6 months.
  • (LVEF) \< lower limit of normal (LLN) per institutional guidelines, or \< 55%, if threshold for normal not otherwise specified by institutional guidelines, for patients with the following risk factors:

    • Prior treatment with anthracyclines
    • Prior treatment with trastuzumab
    • Prior central thoracic radiation therapy (RT), including exposure of heart to therapeutic doses of ionizing RT
    • History of myocardial infarction within 6-12 months prior to start of IPs
    • Prior history of other significant impaired cardiac function.
  • Patients with any of the following:

    • History of myocardial infarction within 6 months prior to starting treatment
    • Unstable angina
    • Resting (ECG) with abnormal findings or with corrected QT interval (QTc) > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
    • functional classification of III or IV.
  • Prior history of hypertensive crisis or hypertensive encephalopathy.
  • Major surgical procedure within 4 weeks prior to starting treatment; patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment.
  • History of intra-abdominal abscess within 3 months prior to starting treatment.
  • Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments.
  • No prior bone marrow transplant or double umbilical cord blood transplantation (dUBCT).
  • Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and transfusions are acceptable).
  • Patients with myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML.
  • Central nervous system :

    • Symptomatic uncontrolled requiring treatment; history of spinal cord compression unless after definitive treatment the patient has clinically stable disease (SD) for at least 28 days prior to starting IPs; in the absence of these features and in an asymptomatic patient a scan to confirm the absence of brain metastases is not required.
  • Other within the last 5 years except for:

    • Curatively treated basal cell or squamous cell carcinoma of skin; in situ cancer of the cervix, ductal carcinoma in situ of the breast or stage 1, grade 1 endometrial carcinoma
    • Curatively treated other solid tumors including lymphomas (without bone marrow involvement) with no evidence of disease for >= 5 years prior to start of IPs.
  • Persisting >= grade 2 (CTCAE) toxicity (except alopecia and grade 2 peripheral neuropathy) from previous anti-cancer treatment(s).
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib, olaparib, AZD5363 (capivasertib), or durvalumab (MEDI4736).
  • Pneumonitis or moderate-severe pre-existing pulmonary disease.
  • Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of therapy within 7 days of enrollment.

    • Premedication with steroids for CT scan contrast is allowed.
    • Inhaled or topical corticosteroids are allowed.
    • The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
    • The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
  • Patients with active disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
  • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice).
Terms in these criteria, in plain language(39)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (actual)

Study arms

  • Experimental
    Arm I (cediranib maleate_reference group 1)

    Patients in reference group 1 receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan

  • Experimental
    Arm II (olaparib)

    Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Olaparib

  • Experimental
    Arm III (cediranib maleate, olaparib)

    Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Olaparib

  • Experimental
    Arm IV (olaparib, capivasertib)

    Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Drug: Capivasertib · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Olaparib

  • Experimental
    Arm V (olaparib, durvalumab)

    Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Procedure: Computed Tomography · Biological: Durvalumab · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan · Drug: Olaparib

  • Experimental
    Arm VI (cediranib maleate, durvalumab)

    Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Drug: Cediranib Maleate · Procedure: Computed Tomography · Biological: Durvalumab · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan

  • Experimental
    Arm VII (cediranib maleate_reference group 2)

    Patients in reference group 1 receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study.

    Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Echocardiography Test · Procedure: Multigated Acquisition Scan

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureBone Marrow Aspirate

    Undergo bone marrow aspiration and biopsy

    Also known as: BONE MARROW, LIQUID, Human Bone Marrow Aspirate

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow aspiration and biopsy

    Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

  • Given PO

    Also known as: AZD 5363, AZD-5363, AZD5363, Truqap

  • Given PO

    Also known as: AZD2171, AZD2171 Maleate, Recentin

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • BiologicalDurvalumab

    Given IV

    Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI 4736, MEDI-4736, MEDI4736

  • ProcedureEchocardiography Test

    Undergo Echo

    Also known as: EC, Echocardiography

  • ProcedureMultigated Acquisition Scan

    Undergo MUGA

    Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNV Scan, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

  • Given PO

    Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281

06

What researchers measure

Primary outcomes

  1. Progression-free Survival

    Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.

    Time frame: Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

Secondary outcomes

  1. Overall Survival

    Overall survival is defined as the time from the date of study enrollment to the date of death regardless of cause. For those individuals who have no death reported at the time of the analysis, the censored time at risk will be assessed from the date of study enrollment to the date that the patient was last contacted and known to be alive.

    Time frame: Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

  2. Objective Tumor Response

    Objective tumor response was assessed in patients with measurable disease by the site investigator using RECIST v1.1. Patients with complete or partial tumor response were considered to have a response.

    Time frame: Scans were done every 8 weeks for the first year; then every 12 weeks thereafter until disease progression is confirmed or up to 33 months.

  3. Incidence of Adverse Events

    The number of patients who reported at least a grade 3 adverse event were assessed in those who initiated treatment.

    Time frame: Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy up to 50 months.

Other outcomes

  1. Mutations in Deoxyribonucleic Acid (DNA) Homologous Repair Genes

    Time frame: Up to 5 years

  2. Markers of Angiogenesis in Serial Plasma Samples

    Will assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib.

    Time frame: Up to 5 years

07

Results

Posted Sep 23, 2025

Participant flow

Trial first activated on 09/04/2018 with reporting groups 1-3. It closed to accrual for reporting groups 1-3 on 06/17/2019. It reopened to accrual for reporting groups 4-7 on 08/16/2021. It closed to accrual for reporting groups 4-7 on 06/28/2023.

Participant flow — Overall Study
MilestoneArm I (Cediranib maleate_Reference Group 1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Reference Group 2)
Started40404042424341
Completed40404042424341
Not completed0000000

Outcome measures

PrimaryProgression-free Survival

Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.

Time frame:
Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).
Reported as:
Median · Months
Progression-free Survival
MonthsArm I (Cediranib maleate_Reference Group 1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Reference Group 2)
Progression-free Survival3.8 (3.0 to 5.4)2.0 (1.8 to 4.7)5.5 (3.7 to 8.3)5.6 (2.6 to 6.0)3.7 (2.2 to 4.9)6.0 (3.8 to 7.8)4.1 (3.0 to 7.0)
Statistical analysis
  • Arm I (Cediranib maleate_Reference Group 1) vs Arm II (Olaparib) · Log Rank · p = 0.93 (Comparing Arm II vs Arm I (reference group)) · Hazard ratio (hr): 1.45 · 95% CI 0.91 to 2.30
  • Arm I (Cediranib maleate_Reference Group 1) vs Arm III (Cediranib Maleate, Olaparib) · Log Rank · p = 0.06 · Hazard ratio (hr): 0.7 · 95% CI 0.43 to 1.14
  • Arm IV (Olaparib, Capivasertib) vs Arm VII (Cediranib maleate_Reference Group 2) · Log Rank · p = 0.62 · Hazard ratio (hr): 1.06 · 95% CI 0.67 to 1.70
  • Arm V (Olaparib, Durvalumab) vs Arm VII (Cediranib maleate_Reference Group 2) · Log Rank · p = 0.36 · Hazard ratio (hr): 0.92 · 95% CI 0.58 to 1.46
  • Arm VI (Cediranib Maleate, Durvalumab) vs Arm VII (Cediranib maleate_Reference Group 2) · Log Rank · p = 0.14 · Hazard ratio (hr): 0.78 · 95% CI 0.49 to 1.25
SecondaryOverall Survival

Overall survival is defined as the time from the date of study enrollment to the date of death regardless of cause. For those individuals who have no death reported at the time of the analysis, the censored time at risk will be assessed from the date of study enrollment to the date that the patient was last contacted and known to be alive.

Time frame:
Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).
Reported as:
Median · Months
Overall Survival
MonthsArm I (Cediranib maleate_Referenc Group 1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Reference Group 2)
Overall Survival12.4 (7.5 to 22.9)13.4 (6.5 to 19.5)17.6 (9.3 to 21.2)16.9 (9.3 to 20.3)14.0 (10.4 to 20.3)22.6 (13.1 to NA)16.6 (8.5 to 20.6)
SecondaryObjective Tumor Response

Objective tumor response was assessed in patients with measurable disease by the site investigator using RECIST v1.1. Patients with complete or partial tumor response were considered to have a response.

Time frame:
Scans were done every 8 weeks for the first year; then every 12 weeks thereafter until disease progression is confirmed or up to 33 months.
Reported as:
Count of participants · Participants
Objective Tumor Response
ParticipantsArm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)
Objective Tumor Response7411811166
SecondaryIncidence of Adverse Events

The number of patients who reported at least a grade 3 adverse event were assessed in those who initiated treatment.

Time frame:
Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy up to 50 months.
Reported as:
Count of participants · Participants
Incidence of Adverse Events
ParticipantsArm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)
Incidence of Adverse Events28193124213128
Other pre-specifiedMutations in Deoxyribonucleic Acid (DNA) Homologous Repair Genes
Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedMarkers of Angiogenesis in Serial Plasma Samples

Will assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Adverse events

Collected over Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy. Median follow-up was 22 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Cediranib maleate_Reference Group 1)23/40 (57.5%)17/39 (43.6%)38/39 (97.4%)
Arm II (Olaparib)26/40 (65%)12/40 (30%)40/40 (100%)
Arm III (Cediranib Maleate, Olaparib)20/40 (50%)19/39 (48.7%)39/39 (100%)
Arm IV (Olaparib, Capivasertib)27/42 (64.3%)11/42 (26.2%)41/42 (97.6%)
Arm V (Olaparib, Durvalumab)28/42 (66.7%)16/42 (38.1%)42/42 (100%)
Arm VI (Cediranib Maleate, Durvalumab)21/43 (48.8%)13/42 (31%)40/42 (95.2%)
Arm VII (Cediranib maleate_Reference Group 2)27/41 (65.9%)19/37 (51.4%)37/37 (100%)
Most frequent serious events
Showing 10 of 76
Most frequent serious events
EventArm I (Cediranib maleate_Reference Group 1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Reference Group 2)
Abdominal PainGastrointestinal disorders2/390/401/391/421/420/424/37
HypertensionVascular disorders0/390/401/390/420/420/424/37
DiarrheaGastrointestinal disorders1/390/401/390/420/421/422/37
Weight LossInvestigations2/390/400/390/420/421/420/37
DehydrationMetabolism and nutrition disorders0/391/402/390/420/420/421/37
Acute Kidney InjuryRenal and urinary disorders0/390/402/390/422/420/421/37
AscitesGastrointestinal disorders0/390/400/390/422/420/420/37
Lymphocyte Count DecreasedInvestigations0/390/400/392/421/420/420/37
Alanine Aminotransferase IncreasedInvestigations0/390/400/390/420/422/420/37
Rash Maculo-PapularSkin and subcutaneous tissue disorders0/390/400/392/420/420/420/37
Most frequent other events
Showing 10 of 300
Most frequent other events
EventArm I (Cediranib maleate_Reference Group 1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Reference Group 2)
DiarrheaGastrointestinal disorders30/3910/4026/3931/4210/4226/4231/37
HypertensionVascular disorders29/399/4031/394/426/4219/4226/37
FatigueGeneral disorders25/3928/4029/3930/4222/4222/4223/37
NauseaGastrointestinal disorders22/3924/4028/3929/4220/4218/4225/37
AnemiaBlood and lymphatic system disorders12/3927/4010/3924/4221/4211/425/37
AnorexiaMetabolism and nutrition disorders16/3912/4016/3911/4210/4215/4220/37
HypothyroidismEndocrine disorders10/391/4011/392/421/4212/4218/37
HeadacheNervous system disorders10/395/4016/393/423/4211/4218/37
Creatinine IncreasedInvestigations5/3910/4014/3918/429/428/426/37
VomitingGastrointestinal disorders16/398/4014/3915/4212/427/427/37

Baseline characteristics

Age, Customized
Age, Customized(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
30-39 years00011002
40-49 years503142318
50-59 years522156324
60-69 years20242524232120157
70-79 years101310147121278
80-89 years01012239
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
Female40404042424341288
Male00000000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
Hispanic or Latino00203229
Not Hispanic or Latino40393741383937271
Unknown or Not Reported01111228
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
American Indian or Alaska Native01000001
Asian102231615
Native Hawaiian or Other Pacific Islander00000000
Black or African American554548536
White34313234333127222
More than one race00000000
Unknown or Not Reported032123314
Prior Immunotherapy
Prior Immunotherapy(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
No36383529292928224
Yes4251313141364
Histology
Histology(Participants)Arm I (Cediranib maleate_Group1)Arm II (Olaparib)Arm III (Cediranib Maleate, Olaparib)Arm IV (Olaparib, Capivasertib)Arm V (Olaparib, Durvalumab)Arm VI (Cediranib Maleate, Durvalumab)Arm VII (Cediranib maleate_Group2)Total
Serous15161617181318113
Endometrioid, Grade 1627539739
Endometrioid, Grade 2968111110661
Endometrioid, Grade 341156610850
Other654341225
08

Study locations

761 sites

Showing the first 100 of 761 sites across 2 countries. Choose a country and city above to see the rest.

09

References and documents

Publications

  • Rimel BJ, Enserro D, Bender DP, Jackson CG, Tan A, Alluri N, Borowsky M, Moroney J, Hendrickson AW, Backes F, Swisher E, Powell M, MacKay H. NRG-GY012: Randomized phase 2 study comparing olaparib, cediranib, and the combination of cediranib/olaparib in women with recurrent, persistent, or metastatic endometrial cancer. Cancer. 2024 Apr 15;130(8):1234-1245. doi: 10.1002/cncr.35151. Epub 2023 Dec 21. PubMed 38127487 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2018 to primary completion in Dec 2024, 74 months.

Results were first posted in Sep 2025, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2018
First posted
Sep 7, 2018
StartActual
Sep 27, 2018
Primary completionActual
Dec 6, 2024
CompletionEst.
Jul 1, 2027
Results first posted
Sep 23, 2025
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added, 2 sites removed
Show 2 added (2 United States)
  • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
  • Saint Anne Hospital · Burien, United States
Show 2 removed
  • West Virginia University Charleston Division · Charleston, United States
  • Highline Medical Center-Main Campus · Burien, United States
across 2 updates, Oct 1, 2026 – Oct 22, 2026
Show all 2 updates
  1. Oct 22, 2026
    1 site added, 1 site removed
    Show site
    • Saint Anne Hospital · Burien, United States
    Show 1 removed
    • Highline Medical Center-Main Campus · Burien, United States
  2. Oct 1, 2026
    1 site added, 1 site removed
    Show site
    • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
    Show 1 removed
    • West Virginia University Charleston Division · Charleston, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT03660826
Collaborators
NRG Oncology
Responsible party
Sponsor
First posted
Sep 7, 2018
Start date
Sep 27, 2018
Primary completion
Dec 6, 2024
Completion
Jul 1, 2027 (estimated)
Results posted
Sep 23, 2025
Last update
Oct 22, 2026

Study contacts

Helen J Mackay
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Capivasertib · Cediranib · Durvalumab · Olaparib

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