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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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2021-06-10
2026-06-14
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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.
Biospecimen Collection
Undergo collection of blood
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Paclitaxel
Given IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Topotecan Hydrochloride
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.
Biospecimen Collection
Undergo collection of blood
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Durvalumab
Given IV
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Olaparib
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.
Biospecimen Collection
Undergo collection of blood
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Durvalumab
Given IV
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
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.
Biospecimen Collection
Undergo collection of blood
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Olaparib
Given PO
Interventions
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Biospecimen Collection
Undergo collection of blood
Cediranib Maleate
Given PO
Computed Tomography
Undergo CT
Computed Tomography with Contrast
Undergo CT with contrast
Durvalumab
Given IV
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Olaparib
Given PO
Paclitaxel
Given IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Topotecan Hydrochloride
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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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
Anchorage Radiation Therapy Center
Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, United States
Sutter Auburn Faith Hospital
Auburn, California, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
John Muir Medical Center-Concord
Concord, California, United States
Sutter Davis Hospital
Davis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Palo Alto Medical Foundation-Fremont
Fremont, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Memorial Medical Center
Modesto, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States
Sutter Roseville Medical Center
Roseville, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, United States
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz, California, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California, United States
City of Hope Upland
Upland, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
CommonSpirit Cancer Center Mercy
Durango, Colorado, United States
Mercy Medical Center
Durango, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States
Banner North Colorado Medical Center - Loveland Campus
Loveland, Colorado, United States
AdventHealth Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
Danbury Hospital
Danbury, Connecticut, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Rush-Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
SIH Cancer Institute
Carterville, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Illinois CancerCare-Dixon
Dixon, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Valley Radiation Oncology
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States
Greater Regional Medical Center
Creston, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, United States
Flaget Memorial Hospital
Bardstown, Kentucky, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, United States
Saint Joseph Hospital East
Lexington, Kentucky, United States
Saint Joseph London
London, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, United States
Our Lady of the Lake Medical Oncology
Baton Rouge, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, United States
Cambridge Medical Center
Cambridge, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Monticello Cancer Center
Monticello, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
Fairview Northland Medical Center
Princeton, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Fairview Lakes Medical Center
Wyoming, Minnesota, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington
Farmington, Missouri, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Center
Missoula, Montana, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, United States
CHI Health Good Samaritan
Kearney, Nebraska, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Midlands Community Hospital
Papillion, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, United States
Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico, United States
Northwell Health Imbert Cancer Center
Bay Shore, New York, United States
Island Gynecologic Oncology
Brightwaters, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Dickstein Cancer Treatment Center
White Plains, New York, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Summa Health System - Akron Campus
Akron, Ohio, United States
Aultman Alliance Community Hospital
Alliance, Ohio, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Geauga Hospital
Chardon, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
Bethesda North Hospital
Cincinnati, Ohio, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Dublin Methodist Hospital
Dublin, Ohio, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OhioHealth Marion General Hospital
Marion, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
Mercy Health - Perrysburg Hospital
Perrysburg, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, United States
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, United States
Saint Charles Health System
Bend, Oregon, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, United States
Bay Area Hospital
Coos Bay, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Saint Charles Health System-Redmond
Redmond, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Bristol Regional Medical Center
Bristol, Tennessee, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Thompson Cancer Survival Center - West
Knoxville, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Methodist Willowbrook Hospital
Houston, Texas, United States
Houston Methodist West Hospital
Houston, Texas, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
Ballad Health Cancer Care - Bristol
Bristol, Virginia, United States
Ballad Health Cancer Care - Norton
Norton, Virginia, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Saint Elizabeth Hospital
Enumclaw, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
PeaceHealth Saint John Medical Center
Longview, Washington, United States
Jefferson Healthcare
Port Townsend, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, United States
Saint Michael Cancer Center
Silverdale, Washington, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, United States
West Virginia University Charleston Division
Charleston, West Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Cancer Center-Metro Medical Center Bayamon
Bayamón, , Puerto Rico
HIMA San Pablo Oncologic Hospital
Caguas, , Puerto Rico
Doctors Cancer Center
ManatÃ, , Puerto Rico
Instituto Oncologia Moderna Ponce
Ponce, , Puerto Rico
San Juan Community Oncology Group
San Juan, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
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
NCI-2021-00615
Identifier Type: -
Identifier Source: org_study_id
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