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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03348631
Other study ID # NCI-2017-02147
Secondary ID NCI-2017-02147NR
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 1, 2019
Est. completion date September 21, 2024

Study information

Verified date September 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well tazemetostat works in treating patients with ovarian or endometrial cancer that has come back (recurrent). Chemotherapy drugs, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Description:

PRIMARY OBJECTIVES: I. To assess the clinical activity (overall response rate) of tazemetostat in patients with recurrent or persistent endometrioid or clear cell ovarian carcinoma, and patients with recurrent or persistent endometrioid endometrial adenocarcinoma. II. To assess the clinical activity (response frequency) of tazemetostat in patients with recurrent or persistent clear cell ovarian carcinoma with an ARID1A mutation. SECONDARY OBJECTIVES: I. To examine the nature and degree of toxicity in patients with this regimen. II. To examine the progression free survival and overall survival for this patient population receiving tazemetostat. III. To examine the 6 month clinical benefit rate in patients treated with this regimen. (20-OCT-2021) IV. To evaluate BAF250a expression in patient samples as an indicator of ARID1A mutation status and correlation with the clinical response to study drug. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) EXPLORATORY OBJECTIVES: I. Whether or not the patient has an ARID1A mutation. (08/13/2019) Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) (Translational Research Integrated Objective) II. To examine the correlation between ARID1A mutation and BAF250a expression and to identify potential mutations predictive of response in patients with preserved BAF250a expression. Note: this only applies to patients enrolled prior to the 20-OCT-2021 version date. (20-OCT-2021) OUTLINE: Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) on study. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 62
Est. completion date September 21, 2024
Est. primary completion date April 14, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically (histologically or cytologically) proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma; patients with recurrent endometrial cancer must have mismatch repair (MMR) immunohistochemistry completed; if they are found to be mismatch repair deficient, they should be offered treatment with immune checkpoint inhibition before consideration for treatment on trial; primary ovarian tumors must be at least 50% endometrioid or clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid or clear cell morphology; institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian tumors (primary or recurrent lesions) - Only patients with recurrent or persistent ovarian clear cell carcinoma (OCCC) with ARID1A pathologic variant or likely pathologic variant mutations per next generation sequencing (NGS) are eligible for entry (20-OCT-2021) - Institutional pathology reports must be provided indicating at least 50% clear cell morphology for ovarian tumors (primary or recurrent lesions) and NGS report must be available for step 1 registration (20-OCT-2021) (09-DEC-2021) - All other eligibility criteria and ineligibility criteria must be met for step 2 registration (20-OCT-2021) (09-DEC-2021) - All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI - Patients must have had at least one, but no more than 3, prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted - Patients must have completed prior therapy: - Chemotherapy: cytotoxic - At least 28 days since last dose of chemotherapy prior to step 2 registration. - Chemotherapy: nitrosoureas - At least 6 weeks since last dose of chemotherapy prior to step 2 registration. - Chemotherapy: non-cytotoxic (e.g. small molecule inhibitor) - At least 28 days since last dose of chemotherapy prior to step 2 registration. - Monoclonal antibody(ies) - At least 28 days since last dose of monoclonal antibody prior to step 2 registration. - Immunotherapy - At least 28 days since last dose of immunotherapy prior to step 2 registration. - Radiotherapy (RT) - At least 14 days from last local site RT prior to step 2 registration. - At least 21 days from stereotactic radiosurgery prior to step 2 registration. - At least 12 weeks from craniospinal, >= 50% radiation of pelvis or total body irradiation prior to step 2 registration. - Patients with central nervous system (CNS) disease should demonstrate evidence of stabilization after the 28-day time point after definitive treatment. - Full recovery of radiation related side effects prior to step 2 registration. - All subjects must have evidence of measurable disease outside of the radiation field at the time of step 2 registration - Appropriate stage for study entry based on the following diagnostic workup: - History/physical examination within 14 days prior to step 2 registration - Imaging of the chest, abdomen and pelvis within 28 days prior to step 2 registration - Age >= 18 - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to step 2 registration - Platelets >= 100,000/mcl (within 14 days prior to step 2 registration) - Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to step 2 registration) - Hemoglobin >= 8 g/dL (within 14 days prior to step 2 registration) - Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing; manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal (within 14 days prior to step 2 registration) - Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to step 2 registration) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to step 2 registration) - Total serum bilirubin level =< 1.5 x ULN; direct bilirubin =< ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's syndrome are eligible) (within 14 days prior to step 2 registration) - Patients must be able to swallow and retain oral medications and not have gastrointestinal illnesses that would preclude absorption of tazemetostat as judged by the treating physician (20-OCT-2021) - Women of childbearing potential must be willing and able to use adequate contraception (hormonal and barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; theoretically, CYP3A induction with tazemetostat use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with tazemetostat (20-OCT-2021) - The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry - 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 (08/13/2019) Exclusion Criteria: - Prior treatment with an investigational EZH2 inhibitor - A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS) - Abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing - A prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) - Patients who have had therapeutic paracentesis or thoracentesis within 8 weeks prior to step 2 registration (20-OCT-2021) - Patients with clinical or radiographic evidence of bowel obstruction (20-OCT-2021) - Severe, active co-morbidity per the treating investigator's discretion - Pregnant or lactating patients - Known human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with tazemetostat; in addition, treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population - Treatment with strong and moderate inhibitors or inducers of CYP3A within 14 days of step 2 registration and during the study treatment (20-OCT-2021)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Drug:
Tazemetostat
Given PO

Locations

Country Name City State
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Riverwood Healthcare Center Aitkin Minnesota
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Aultman Alliance Community Hospital Alliance Ohio
United States Saint Anthony's Health Alton Illinois
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
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 Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Northside Hospital Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Eastern Maine Medical Center Bangor Maine
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Baton Rouge General Medical Center Baton Rouge Louisiana
United States Hematology/Oncology Clinic PLLC Baton Rouge Louisiana
United States Essentia Health - Baxter Clinic Baxter Minnesota
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Overlake Medical Center Bellevue Washington
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Saint Charles Health System Bend Oregon
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic Cancer Center Billings Montana
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Bozeman Deaconess Hospital Bozeman Montana
United States Florida Cancer Specialists - Bradenton Cancer Center Bradenton Florida
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Harrison Medical Center Bremerton Washington
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Aultman Health Foundation Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Geauga Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
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 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Memorial Hospital North Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States AMG Crystal Lake - Oncology Crystal Lake Illinois
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Porter Adventist Hospital Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Dublin Methodist Hospital Dublin Ohio
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Advocate Sherman Hospital Elgin Illinois
United States Essentia Health - Ely Clinic Ely Minnesota
United States Walter Knox Memorial Hospital Emmett Idaho
United States Saint Elizabeth Hospital Enumclaw Washington
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Saint Francis Hospital Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Parkview Regional Medical Center Fort Wayne Indiana
United States Essentia Health - Fosston Fosston Minnesota
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States CTCA at Western Regional Medical Center Goodyear Arizona
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States CHI Health Saint Francis Grand Island Nebraska
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States UCHealth Greeley Hospital Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States Wayne Hospital Greenville Ohio
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
United States Memorial Sloan Kettering Westchester Harrison New York
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Essentia Health-Hayward Clinic Hayward Wisconsin
United States Advocate South Suburban Hospital Hazel Crest Illinois
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Kuakini Medical Center Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Essentia Health - International Falls Clinic International Falls Minnesota
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States McFarland Clinic - Jefferson Jefferson Iowa
United States Capital Region Southwest Campus Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Sparrow Hospital Lansing Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States AMG Libertyville - Oncology Libertyville Illinois
United States Condell Memorial Hospital Libertyville Illinois
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Rita's Medical Center Lima Ohio
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
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 Medical Center of the Rockies Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States OhioHealth Mansfield Hospital Mansfield Ohio
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 Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bon Secours Westchester Emergency Center Midlothian Virginia
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Forbes Hospital Monroeville Pennsylvania
United States Monticello Cancer Center Monticello Minnesota
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Essentia Health - Moose Lake Clinic Moose Lake Minnesota
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Providence Queen of The Valley Napa California
United States Mount Carmel New Albany Surgical Hospital New Albany Ohio
United States Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut
United States Yale University New Haven Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Tulane University Health Sciences Center New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Memorial Sloan Kettering Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States CTCA at Southeastern Regional Medical Center Newnan Georgia
United States Bon Secours DePaul Medical Center Norfolk Virginia
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Advocate Christ Medical Center Oak Lawn Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Saint Luke's South Hospital Overland Park Kansas
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Parker Adventist Hospital Parker Colorado
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Mayo Clinic Hospital in Arizona Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Huron Medical Center PC Port Huron Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Bon Secours Maryview Medical Center Portsmouth Virginia
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Saint Charles Health System-Redmond Redmond Oregon
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Providence Medical Foundation - Santa Rosa Santa Rosa California
United States Providence Santa Rosa Memorial Hospital Santa Rosa California
United States Florida Cancer Specialists - Sarasota Sarasota Florida
United States Florida Cancer Specialists - Sarasota Downtown Sarasota Florida
United States Sarasota Memorial Hospital Sarasota Florida
United States Memorial Health University Medical Center Savannah Georgia
United States Summit Cancer Care-Memorial Savannah Georgia
United States Mayo Clinic in Arizona Scottsdale Arizona
United States Community Medical Center Scranton Pennsylvania
United States Kaiser Permanente Washington Seattle 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 Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Avera Cancer Institute Sioux Falls South Dakota
United States Essentia Health-Spooner Clinic Spooner Wisconsin
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Geisinger Medical Group State College Pennsylvania
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Lakeview Hospital Stillwater Minnesota
United States Bon Secours Health Center at Harbour View Suffolk Virginia
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin
United States Southwest Illinois Health Services LLP Swansea Illinois
United States ProMedica Flower Hospital Sylvania Ohio
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States Saint Vincent Mercy Medical Center Toledo Ohio
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Memorial Sloan Kettering Nassau Uniondale New York
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Florida Cancer Specialists - Venice Healthpark Venice Florida
United States Florida Cancer Specialists - Venice Island Venice Florida
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States Associates In Womens Health Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Fairview Lakes Medical Center Wyoming Minnesota
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio
United States Midwestern Regional Medical Center Zion Illinois

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other ARID1A mutational status Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation). Up to 6 months
Other BAF250a expression Will be assessed by immunohistochemistry. Associations between BAF250a and ARID1A mutations may be examined with contingency table analysis (e.g. potentially including Chi-square analyses or Spearman's correlation). Up to 6 months
Primary Tumor response Will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Up to 6 months
Secondary Tumor response in patients with ARID1A mutations using tumor response (Removed as of version date 20-OCT-2021) Will be defined by RECIST v 1.1. Up to 6 months
Secondary 6-month progression free survival (clinical benefit rate) Up to 6 months
Secondary Incidence of adverse events Will be assessed according to grade of toxicity by organ or organ system. Up to 5 years
Secondary Progression-free survival Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations. From study entry to time of progression or death, whichever occurs first, assessed up to 5 years
Secondary Overall survival Will be characterized by quartiles and the median of the distribution with confidence intervals. Kaplan-Meier plots will show an estimate of the survival function for these populations. From study entry to time of death or the date of last contact, assessed up to 5 years
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