AzTrials
AzTrials

Fallopian Tube Mucinous AdenocarcinomaPhase 2NCT04739800

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

A Phase 2 study testing Biospecimen Collection, Cediranib Maleate and Computed Tomography in people with Fallopian Tube Mucinous Adenocarcinoma and Ovarian Seromucinous Carcinoma, run by National Cancer Institute (NCI) at 391 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Cediranib Maleate and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
391 sitesin 2 countries
Study dates
10 Jun 2021to 25 Jun 2027
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

391 sites in 2 countries.

307 sites in 2 countries

United States300 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

  • OSF Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • CommonSpirit Saint Joseph Hospital - Bardstown

    Bardstown, Kentucky, 40004

  • Our Lady of the Lake Medical Oncology

    Baton Rouge, Louisiana, 70817

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Island Gynecologic Oncology

    Brightwaters, New York, 11718

  • Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Ballad Health Cancer Care - Bristol

    Bristol, Virginia, 24201

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Saint Anne Hospital

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Mercy Cancer Center - Cape Girardeau

    Cape Girardeau, Missouri, 63703

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

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

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • John Muir Medical Center-Concord

    Concord, California, 94520

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Sutter Davis Hospital

    Davis, California, 95616

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • CommonSpirit Cancer Center Mercy

    Durango, Colorado, 81301

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Central Ohio Breast and Endocrine Surgery

    Gahanna, Ohio, 43230

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Sudarshan K Sharma MD Limited-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Methodist Willowbrook Hospital

    Houston, Texas, 77070

  • Houston Methodist West Hospital

    Houston, Texas, 77094

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Ballad Health Cancer Care - Kingsport

    Kingsport, Tennessee, 37660

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Covenant Health Cancer Centers

    Knoxville, Tennessee, 37916

  • Covenant Health Cancer Centers - West

    Knoxville, Tennessee, 37932

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • CommonSpirit Saint Anthony Hospital Cancer Center

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Memorial Medical Center-Las Cruces

    Las Cruces, New Mexico, 88011

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • CommonSpirit Saint Joseph Hospital London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Medical Center

    Modesto, California, 95355

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Newark Radiation Oncology

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • Ballad Health Cancer Care - Norton

    Norton, Virginia, 24273

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • AdventHealth Parker

    Parker, Colorado, 80138

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Mercy Health - Perrysburg Hospital

    Perrysburg, Ohio, 43551

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

Other trials in United States

Puerto Rico7 sites

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726

  • Doctors Cancer Center

    Manati, 00674

  • Instituto Oncologia Moderna Ponce

    Ponce, 00716

  • San Juan Community Oncology Group

    San Juan, 00917

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Cediranib Maleate, Computed Tomography, Computed Tomography with Contrast, Durvalumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood

  • Cediranib MaleateDrug

    Also called AZD2171, AZD2171 Maleate, Recentin

    Given PO

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Computed Tomography with ContrastProcedure or surgery

    Also called Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast

    Undergo CT with contrast

  • DurvalumabBiological

    Also called 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

    Given IV

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • OlaparibDrug

    Also called AZD 2281, AZD-2281, AZD2281, KU 0059436

    Given PO

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Pegylated Liposomal Doxorubicin HydrochlorideDrug

    Also called ATI-0918, Caelyx, Dox-SL, Doxil

    Given IV

  • Topotecan HydrochlorideDrug

    Also called Evotopin, Hycamptamine, Hycamtin, Nogitecan Hydrochloride

    Given IV

Study groups in NCT04739800
Study groupRoleWhat they receive
Arm I (paclitaxel, doxorubicin, topotecan hydrochloride))Active comparatorPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Computed Tomography with Contrast; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Paclitaxel; Drug: Pegylated Liposomal Doxorubicin Hydrochloride; Drug: Topotecan Hydrochloride
Arm II (durvalumab, cediranib maleate, olaparib)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Drug: Cediranib Maleate; Procedure: Computed Tomography; Procedure: Computed Tomography with Contrast; Biological: Durvalumab; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Drug: Olaparib
Arm III (durvalumab, cediranib maleate)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Drug: Cediranib Maleate; Procedure: Computed Tomography; Procedure: Computed Tomography with Contrast; Biological: Durvalumab; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan
Arm IV (cediranib maleate, olaparib)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Drug: Cediranib Maleate; Procedure: Computed Tomography; Procedure: Computed Tomography with Contrast; Procedure: Echocardiography Test; Procedure: Magnetic Resonance Imaging; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    The relationship of randomized treatment assignment to progression free survival. The RECIST 1.1 criteria are used for disease progression. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

    Measured: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 4.8 months (Inter-Quartile Range: 2.0-7.9 months).

Secondary outcomes (4)

  1. Objective Response Rate

    Determination of response should take into consideration all target and non-target lesions. Here are the definitions of CR, PR, PD and SD: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters (i.e. the nadir) while on study. The CI is the Jeffreys interval.

    Measured: From the start of the treatment until disease progression/recurrence, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

  2. Duration of Response

    Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. Duration of response was defined as the time from the first documentation of objective tumor response (complete response (CR) or partial response (PR)) to the first documented progressive disease (PD), or to death due to any cause, whichever occurs first.

    Per RECIST, Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as an >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Reporting the number of months from complete or partial response until disease progression, death or censoring, whichever occurs first. In the absence of disease progression or death, censoring time is based on date of last CT scan.

    Measured: Throughout study treatment, up to 10.6 months.

  3. Overall Survival

    Overall survival will be presented by Kaplan Meier methods. Overall Survival (OS) is defined as the duration of time from study entry to date of death from any cause. A subject who has not died will be censored on the date that they were last known to be alive.

    Measured: Time from study entry to date of death from any cause, or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

  4. Count of Participants With a Grade 3 (or Higher) Adverse Event

    The number of patients (in each reporting group) who experienced a grade 3 (or higher) adverse event

    Measured: From the start of treatment until disease progression/recurrence or termination by the DMC. The median followup time was 4.3 months. The maximum followup time was 11 months. Patients are no longer being assessed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2021
  2. Study start10 Jun 2021
  3. Primary completion26 Jan 2023
  4. Study completion25 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739800
Sponsor's protocol ID
NCI-2021-00615
Other IDs
NCI-2021-00615, NRG-GY023, NRG-GY023, U10CA180868
Status last verified
Jul 2026
First submitted
4 Feb 2021
Last updated
22 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

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