Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents

NCT ID: NCT04739800

Last Updated: 2025-12-04

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-10

Study Completion Date

2026-06-14

Brief Summary

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This phase II trial studies 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 that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by progression-free survival (PFS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

SECONDARY OBJECTIVES:

I. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

II. To assess the efficacy of the combinations durvalumab (MEDI4736) plus olaparib and cediranib, durvalumab (MEDI4736) plus cediranib, or olaparib and cediranib, as measured by overall survival (OS), as compared to physician's choice standard of care chemotherapy, in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer who had prior bevacizumab.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive paclitaxel intravenously (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and as clinically indicated on study. Patients also undergo collection of blood and computed tomography (CT) with contrast during screening, and CT or magnetic resonance imaging (MRI) scans throughout the trial.

ARM II: Patients receive durvalumab IV over 60 minutes on day 1, cediranib maleate orally (PO) once daily (QD) Monday through Friday, and olaparib PO twice daily (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.

ARM III: 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.

ARM IV: 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.

After completion of study treatment, patients are followed up periodically for up to 5 years.

Conditions

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Fallopian Tube Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Platinum-Refractory Fallopian Tube Carcinoma Platinum-Refractory Ovarian Carcinoma Platinum-Refractory Primary Peritoneal Carcinoma Recurrent Fallopian Tube Clear Cell Adenocarcinoma Recurrent Fallopian Tube Endometrioid Adenocarcinoma Recurrent Fallopian Tube High Grade Serous Adenocarcinoma Recurrent Fallopian Tube Mucinous Adenocarcinoma Recurrent Fallopian Tube Transitional Cell Carcinoma Recurrent Fallopian Tube Undifferentiated Carcinoma Recurrent Low Grade Fallopian Tube Serous Adenocarcinoma Recurrent Ovarian Clear Cell Adenocarcinoma Recurrent Ovarian Endometrioid Adenocarcinoma Recurrent Ovarian High Grade Serous Adenocarcinoma Recurrent Ovarian Low Grade Serous Adenocarcinoma Recurrent Ovarian Mucinous Adenocarcinoma Recurrent Ovarian Seromucinous Carcinoma Recurrent Ovarian Transitional Cell Carcinoma Recurrent Ovarian Undifferentiated Carcinoma Recurrent Platinum-Resistant Fallopian Tube Carcinoma Recurrent Platinum-Resistant Ovarian Carcinoma Recurrent Platinum-Resistant Primary Peritoneal Carcinoma Recurrent Primary Peritoneal Clear Cell Adenocarcinoma Recurrent Primary Peritoneal Endometrioid Adenocarcinoma Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma Recurrent Primary Peritoneal Low Grade Serous Adenocarcinoma Recurrent Primary Peritoneal Transitional Cell Carcinoma Recurrent Primary Peritoneal Undifferentiated Carcinoma Refractory Fallopian Tube Clear Cell Adenocarcinoma Refractory Fallopian Tube Endometrioid Adenocarcinoma Refractory Fallopian Tube High Grade Serous Adenocarcinoma Refractory Fallopian Tube Mucinous Adenocarcinoma Refractory Fallopian Tube Transitional Cell Carcinoma Refractory Fallopian Tube Undifferentiated Carcinoma Refractory Low Grade Fallopian Tube Serous Adenocarcinoma Refractory Ovarian Clear Cell Adenocarcinoma Refractory Ovarian Endometrioid Adenocarcinoma Refractory Ovarian High Grade Serous Adenocarcinoma Refractory Ovarian Low Grade Serous Adenocarcinoma Refractory Ovarian Mucinous Adenocarcinoma Refractory Ovarian Seromucinous Carcinoma Refractory Ovarian Transitional Cell Carcinoma Refractory Ovarian Undifferentiated Carcinoma Refractory Primary Peritoneal Clear Cell Adenocarcinoma Refractory Primary Peritoneal Endometrioid Adenocarcinoma Refractory Primary Peritoneal High Grade Serous Adenocarcinoma Refractory Primary Peritoneal Low Grade Serous Adenocarcinoma Refractory Primary Peritoneal Transitional Cell Carcinoma Refractory Primary Peritoneal Undifferentiated Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (paclitaxel, doxorubicin, topotecan hydrochloride))

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.

Group Type ACTIVE_COMPARATOR

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Computed Tomography with Contrast

Intervention Type PROCEDURE

Undergo CT with contrast

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Paclitaxel

Intervention Type DRUG

Given IV

Pegylated Liposomal Doxorubicin Hydrochloride

Intervention Type DRUG

Given IV

Topotecan Hydrochloride

Intervention Type DRUG

Given IV

Arm II (durvalumab, cediranib maleate, olaparib)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cediranib Maleate

Intervention Type DRUG

Given PO

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Computed Tomography with Contrast

Intervention Type PROCEDURE

Undergo CT with contrast

Durvalumab

Intervention Type BIOLOGICAL

Given IV

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Olaparib

Intervention Type DRUG

Given PO

Arm III (durvalumab, cediranib maleate)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cediranib Maleate

Intervention Type DRUG

Given PO

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Computed Tomography with Contrast

Intervention Type PROCEDURE

Undergo CT with contrast

Durvalumab

Intervention Type BIOLOGICAL

Given IV

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type PROCEDURE

Undergo MUGA

Arm IV (cediranib maleate, olaparib)

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 Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood

Cediranib Maleate

Intervention Type DRUG

Given PO

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Computed Tomography with Contrast

Intervention Type PROCEDURE

Undergo CT with contrast

Echocardiography Test

Intervention Type PROCEDURE

Undergo ECHO

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Olaparib

Intervention Type DRUG

Given PO

Interventions

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Biospecimen Collection

Undergo collection of blood

Intervention Type PROCEDURE

Cediranib Maleate

Given PO

Intervention Type DRUG

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Computed Tomography with Contrast

Undergo CT with contrast

Intervention Type PROCEDURE

Durvalumab

Given IV

Intervention Type BIOLOGICAL

Echocardiography Test

Undergo ECHO

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Intervention Type PROCEDURE

Olaparib

Given PO

Intervention Type DRUG

Paclitaxel

Given IV

Intervention Type DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

Intervention Type DRUG

Topotecan Hydrochloride

Given IV

Intervention Type DRUG

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection AZD2171 AZD2171 Maleate Recentin 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 Contrast Enhanced Computed Tomography CONTRAST ENHANCED CT SCAN Contrast-enhanced Computed Tomography CT Scan With Contrast CT with Contrast 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 EC Echocardiography Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI 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 AZD 2281 AZD-2281 AZD2281 KU 0059436 KU-0059436 KU0059436 Lynparza Olanib Olaparix PARP Inhibitor AZD2281 Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat ATI-0918 Caelyx Dox-SL Doxil Doxilen Doxorubicin HCl Liposomal Doxorubicin HCl Liposome Doxorubicin Hydrochloride Liposome Duomeisu Evacet LipoDox Lipodox 50 Liposomal Adriamycin Liposomal Doxorubicin Hydrochloride Liposomal-Encapsulated Doxorubicin Pegylated Doxorubicin HCl Liposome Pegylated Liposomal Doxorubicin S-Liposomal Doxorubicin Stealth Liposomal Doxorubicin TLC D-99 Evotopin Hycamptamine Hycamtin Nogitecan Hydrochloride Potactasol SKF S 104864 A SKF S-104864-A SKF S104864A Topotec Topotecan HCl topotecan hydrochloride (oral)

Eligibility Criteria

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Inclusion Criteria

* Women with recurrent/persistent platinum-resistant ovarian, primary peritoneal, or fallopian tube cancers; platinum-resistant disease is defined as progression within \< 6 months from completion of platinum based therapy. The date should be calculated from the last administered dose of platinum therapy
* Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of high grade serous, grade 3 endometrioid or clear cell carcinoma based on local histopathological findings. Patients with low grade serous, grade 1 or 2 endometrioid, mixed epithelial, undifferentiated carcinoma, or mucinous carcinoma histologies are also eligible, provided that the patient has a known deleterious BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory. Histologic confirmation of the original primary tumor is required via the pathology report (upload of report required). Confirmation of BRCA1 and BRCA2 germline and/or somatic mutation status and hormone receptor (HR) status is required for all entered patients (if available) via testing report (upload of report\[s\] required)
* 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 \[ULN\])
* Prior therapy:

* At least two prior treatment regimens (including primary therapy) but up to 5 lines of systemic anticancer therapy. Hormonal therapy (such as tamoxifen, aromatase inhibitors) will not count as a previous treatment regimen.
* Prior use of bevacizumab in the upfront or recurrent setting is required.
* Prior use of PARP inhibitor is allowed.
* Prior use of immune checkpoint blockade (e.g., a PD-L1/PD-1inhibitor or a CTLA-4 inhibitor) is allowed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Absolute neutrophil count (ANC) \>= 1,500/mcL
* Hemoglobin \> 10 g/dL
* Platelets \>= 100,000/mcL
* Creatinine clearance (CrCL) or estimated glomerular filtration rate (eGFR) of \> 50 mL/min estimated using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR)
* Urine protein: creatinine ratio (UPC) of =\< 1
* Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\< 3 x ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN
* Age \>= 18 years
* Body weight \> 30 kg
* Adequately controlled blood pressure (systolic blood pressure \[SBP\] =\< 140; diastolic blood pressure \[DBP\] =\< 90 mmHg) on a maximum of three antihypertensive medications. Patients must have a BP of =\< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to study registration. It is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on protocol. Patients must be willing and able to check and record daily blood pressure readings. BP cuffs will be provided to patients randomized to the cediranib-containing arms
* Adequately controlled thyroid dysfunction with no symptoms of thyroid dysfunction and normal thyroid stimulating hormone (TSH). If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal free T4 level is required
* Able to swallow and retain oral medications and no gastrointestinal (GI) illnesses that would preclude absorption of olaparib and cediranib as judged by treating physician
* 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
* Women of childbearing potential (WOCBP) must agree to use two forms of birth control (hormonal or barrier method of birth control; abstinence). Note: Definition of women of no longer having childbearing potential: Postmenopausal 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 study treatment. Postmenopausal is defined as: Age \>= 60 years, or age \< 60 with any one or more of the conditions below:

* Amenorrhoeic 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)
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and authorization permitting release of personal health information

Exclusion Criteria

* Primary platinum-refractory disease defined as progression during first-line platinum-based chemotherapy
* Rising CA-125 only without RECIST 1.1 evaluable disease
* Prior therapy:

* Patients who have had chemotherapy, investigational drugs or radiotherapy within 3 weeks prior to study registration or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Patients may not have had hormonal therapy within 2 weeks of study registration. Patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions.
* Prior use of concurrent olaparib and cediranib combination.
* Patients who have experienced immune-mediated adverse events requiring dose modification or discontinuation.
* For patients who have received prior PARP inhibitor:

* Patients who have required dose modification or dose reduction of olaparib will not be eligible, as they will not be able to start this study at full dose.
* Patients who have required dose reduction of non-olaparib PARP inhibitors for hematologic adverse events will not be eligible (Note: niraparib that is initiated at 200mg daily per weight and platelet guidelines is not considered a dose reduction).
* Patients who required dose-reduction of non-olaparib PARP inhibitors for non-hematologic adverse events may be eligible after discussion with the Study Chair if the treating investigator feels that they could appropriately receive olaparib at full dose.
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 3 months prior to study registration
* Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months of study registration except temporary (\< 24 hr) improved with medical management, within last 3 months
* Any prior grade \>= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \> grade 1
* Dependency on IV hydration or total parenteral nutrition (TPN)
* Pregnant women. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events. Patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study registration
* Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities. Patients with any cardiac history of the following conditions:

* History of myocardial infarction or myocarditis within six months of study registration
* Unstable angina
* Resting electrocardiogram (ECG) with clinically significant abnormal findings.
* New York Heart Association functional classification of III or IV
* If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or \< 55%, if threshold for normal not otherwise specified by institutional guidelines. Patients with the following risk factors should have a baseline cardiac function assessment:

* Prior treatment with anthracyclines
* Prior treatment with trastuzumab or T-DM1
* Prior central thoracic radiation therapy (RT), including RT to the heart
* History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)
* Prior history of impaired cardiac function
* History of stroke or transient ischemic attack within six months of study registration
* Clinically significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study treatment. Patients must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment. Note: Local surgery of isolated lesions for palliative intent is acceptable
* Evidence of coagulopathy or bleeding diathesis. Therapeutic anticoagulation for prior thromboembolic events, including warfarin, is permitted. Patients receiving warfarin are recommended to have careful monitoring of international normalized ratio (INR)
* Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated. No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
* Human immunodeficiency virus (HIV) positive patients due to potential drug and drug interactions
* 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
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events or compromise the ability of the patient to given written informed consent
* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4. Dihydropyridine calcium-channel blockers are permitted for management of hypertension
* Current or prior use of immunosuppressive medication within 14 days of study registration. The following are exceptions to this criterion:

* Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab, olaparib, or cediranib
* Patients with active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen (HBsAg) result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for hepatitis C virus (HCV) ribonucleic acid (RNA)
* Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NRG Oncology

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jung-min Lee

Role: PRINCIPAL_INVESTIGATOR

NRG Oncology

Locations

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Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Site Status

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status

Sutter Auburn Faith Hospital

Auburn, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Auburn

Auburn, California, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Cameron Park, California, United States

Site Status

Eden Hospital Medical Center

Castro Valley, California, United States

Site Status

John Muir Medical Center-Concord

Concord, California, United States

Site Status

Sutter Davis Hospital

Davis, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Site Status

City of Hope Antelope Valley

Lancaster, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Site Status

Palo Alto Medical Foundation-Gynecologic Oncology

Mountain View, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Site Status

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Site Status

City of Hope South Pasadena

South Pasadena, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

City of Hope Upland

Upland, California, United States

Site Status

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status

John Muir Medical Center-Walnut Creek

Walnut Creek, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

AdventHealth Porter

Denver, Colorado, United States

Site Status

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Site Status

Mercy Medical Center

Durango, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

AdventHealth Littleton

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

Site Status

AdventHealth Parker

Parker, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

Danbury Hospital

Danbury, Connecticut, United States

Site Status

Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Site Status

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status

SIH Cancer Institute

Carterville, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status

Rush MD Anderson Cancer Center

Chicago, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status

Carle at The Riverfront

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status

Sudarshan K Sharma MD Limited-Gynecologic Oncology

Hinsdale, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Site Status

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status

Midwestern Regional Medical Center

Zion, Illinois, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Site Status

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Site Status

Greater Regional Medical Center

Creston, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Site Status

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Site Status

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Site Status

Saint Joseph Hospital East

Lexington, Kentucky, United States

Site Status

Saint Joseph London

London, Kentucky, United States

Site Status

Jewish Hospital

Louisville, Kentucky, United States

Site Status

Saints Mary and Elizabeth Hospital

Louisville, Kentucky, United States

Site Status

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status

Jewish Hospital Medical Center South

Shepherdsville, Kentucky, United States

Site Status

Our Lady of the Lake Medical Oncology

Baton Rouge, Louisiana, United States

Site Status

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Site Status

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

Site Status

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Site Status

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Site Status

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Site Status

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, United States

Site Status

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status

Mercy Infusion Center - Chippewa

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital South

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Site Status

Mercy Hospital Washington

Washington, Missouri, United States

Site Status

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Great Falls Clinic

Great Falls, Montana, United States

Site Status

Logan Health Medical Center

Kalispell, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

Community Medical Center

Missoula, Montana, United States

Site Status

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Site Status

Cancer Partners of Nebraska

Lincoln, Nebraska, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Midlands Community Hospital

Papillion, Nebraska, United States

Site Status

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status

Jersey Shore Medical Center

Neptune City, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Memorial Medical Center-Las Cruces

Las Cruces, New Mexico, United States

Site Status

Presbyterian Rust Medical Center/Jorgensen Cancer Center

Rio Rancho, New Mexico, United States

Site Status

Northwell Health Imbert Cancer Center

Bay Shore, New York, United States

Site Status

Island Gynecologic Oncology

Brightwaters, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status

Dickstein Cancer Treatment Center

White Plains, New York, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Summa Health System - Akron Campus

Akron, Ohio, United States

Site Status

Aultman Alliance Community Hospital

Alliance, Ohio, United States

Site Status

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status

Aultman Health Foundation

Canton, Ohio, United States

Site Status

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status

Geauga Hospital

Chardon, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Site Status

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status

TriHealth Cancer Institute-Westside

Cincinnati, Ohio, United States

Site Status

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Mount Carmel East Hospital

Columbus, Ohio, United States

Site Status

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Dublin Methodist Hospital

Dublin, Ohio, United States

Site Status

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, United States

Site Status

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

Saint Rita's Medical Center

Lima, Ohio, United States

Site Status

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Newark Radiation Oncology

Newark, Ohio, United States

Site Status

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

Mercy Health - Saint Vincent Hospital

Toledo, Ohio, United States

Site Status

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status

University Hospitals Sharon Health Center

Wadsworth, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma Cancer Specialists and Research Institute-Tulsa

Tulsa, Oklahoma, United States

Site Status

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, United States

Site Status

Saint Charles Health System

Bend, Oregon, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Saint Charles Health System-Redmond

Redmond, Oregon, United States

Site Status

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Site Status

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Site Status

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status

Women and Infants Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Saint Francis Hospital

Greenville, South Carolina, United States

Site Status

Saint Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Bristol Regional Medical Center

Bristol, Tennessee, United States

Site Status

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, United States

Site Status

Wellmont Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

Site Status

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status

Thompson Cancer Survival Center - West

Knoxville, Tennessee, United States

Site Status

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Site Status

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Saint Joseph Regional Cancer Center

Bryan, Texas, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Methodist Willowbrook Hospital

Houston, Texas, United States

Site Status

Houston Methodist West Hospital

Houston, Texas, United States

Site Status

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Site Status

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States

Site Status

Ballad Health Cancer Care - Bristol

Bristol, Virginia, United States

Site Status

Ballad Health Cancer Care - Norton

Norton, Virginia, United States

Site Status

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Highline Medical Center-Main Campus

Burien, Washington, United States

Site Status

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status

Saint Elizabeth Hospital

Enumclaw, Washington, United States

Site Status

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status

Saint Francis Hospital

Federal Way, Washington, United States

Site Status

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status

Saint Clare Hospital

Lakewood, Washington, United States

Site Status

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status

Swedish Medical Center-Ballard Campus

Seattle, Washington, United States

Site Status

Swedish Medical Center-Cherry Hill

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

Site Status

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status

Saint Michael Cancer Center

Silverdale, Washington, United States

Site Status

Franciscan Research Center-Northwest Medical Plaza

Tacoma, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status

West Virginia University Charleston Division

Charleston, West Virginia, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status

Cancer Center-Metro Medical Center Bayamon

Bayamón, , Puerto Rico

Site Status

HIMA San Pablo Oncologic Hospital

Caguas, , Puerto Rico

Site Status

Doctors Cancer Center

Manatí, , Puerto Rico

Site Status

Instituto Oncologia Moderna Ponce

Ponce, , Puerto Rico

Site Status

San Juan Community Oncology Group

San Juan, , Puerto Rico

Site Status

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

Site Status

San Juan City Hospital

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2021-00615

Identifier Type: REGISTRY

Identifier Source: secondary_id

NRG-GY023

Identifier Type: OTHER

Identifier Source: secondary_id

NRG-GY023

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-00615

Identifier Type: -

Identifier Source: org_study_id

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