Metastatic Renal Cell Carcinoma Clinical Trial
— PROBEOfficial title:
Phase III Trial of Immunotherapy-Based Combination Therapy With or Without Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma (PROBE Trial)
This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.
Status | Recruiting |
Enrollment | 364 |
Est. completion date | July 2033 |
Est. primary completion date | July 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants with multifocal or bilateral tumors are eligible - STEP 1 REGISTRATION: Participants must have primary tumor in place - STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease: - Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given) - CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast Scans must be performed within the following timeframes: - Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration - Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment - STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration - STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy - STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System - STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines - STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment - CT scan of the chest (can be performed without contrast if CT contrast cannot be given) - CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI of the chest, abdomen and pelvis obtained prior to starting pre-randomization treatment. Participants with complete response in all metastatic sites are not eligible to randomize to Step 2 • STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment - Stable disease - Partial response - The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1 - STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment - STEP 2 REGISTRATION: Participants must be randomized on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy - STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy: - 2 infusions of nivolumab + 1 infusion of ipilimumab - 2 infusions of pembrolizumab - 2 infusions of avelumab - STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization - STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization - STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization - STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization - STEP 2 REGISTRATION: Total bilirubin =< institutional upper limit of normal (ULN) (within 28 days prior to randomization) - STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) - STEP 2 REGISTRATION: Serum creatinine =< 1.5 x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization) Exclusion Criteria: - STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease - STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma: - Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy - Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment - STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment: - Treatment naive participants must not have received any pre-randomization treatment. - Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment: - 4 infusions of nivolumab - 4 infusions of ipilimumab - 4 infusions of pembrolizumab - 7 infusions of avelumab - STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes: - Treatment naive participants must not have received any immunotherapy within a year of registration - Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment - STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney - STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for at least two years - STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy - STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed - STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain metastasis. Brain imaging studies are not required. If brain imaging studies are performed, they must be negative for disease - STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the participant is currently in complete remission, or any other cancer from which the participant has been disease free for two years |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | AdventHealth Altamonte | Altamonte Springs | Florida |
United States | Saint Anthony's Health | Alton | Illinois |
United States | UPMC Altoona | Altoona | Pennsylvania |
United States | Mary Greeley Medical Center | Ames | Iowa |
United States | McFarland Clinic - Ames | Ames | Iowa |
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | PCR Oncology | Arroyo Grande | California |
United States | Sutter Auburn Faith Hospital | Auburn | California |
United States | Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California |
United States | Rush - Copley Medical Center | Aurora | Illinois |
United States | UH Seidman Cancer Center at UH Avon Health Center | Avon | Ohio |
United States | Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri |
United States | Advocate Good Shepherd Hospital | Barrington | Illinois |
United States | Hematology/Oncology Clinic PLLC | Baton Rouge | Louisiana |
United States | Bronson Battle Creek | Battle Creek | Michigan |
United States | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio |
United States | UPMC-Heritage Valley Health System Beaver | Beaver | Pennsylvania |
United States | Indu and Raj Soin Medical Center | Beavercreek | Ohio |
United States | Overlake Medical Center | Bellevue | Washington |
United States | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Illinois CancerCare-Bloomington | Bloomington | Illinois |
United States | Saint Elizabeth Boardman Hospital | Boardman | Ohio |
United States | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina |
United States | Central Care Cancer Center - Bolivar | Bolivar | Missouri |
United States | McFarland Clinic - Boone | Boone | Iowa |
United States | Cox Cancer Center Branson | Branson | Missouri |
United States | University of Michigan - Brighton Center for Specialty Care | Brighton | Michigan |
United States | Henry Ford Cancer Institute-Downriver | Brownstown | Michigan |
United States | Keck Medicine of USC Buena Park | Buena Park | California |
United States | Roswell Park Cancer Institute | Buffalo | New York |
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 | Loyola Center for Health at Burr Ridge | Burr Ridge | Illinois |
United States | UPMC Hillman Cancer Center at Butler Health System | Butler | Pennsylvania |
United States | Cambridge Medical Center | Cambridge | Minnesota |
United States | Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California |
United States | Illinois CancerCare-Canton | Canton | Illinois |
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 | Saint Anthony Regional Hospital | Carroll | Iowa |
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 | Eden Hospital Medical Center | Castro Valley | California |
United States | AdventHealth Celebration | Celebration | Florida |
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 | Saint Mary's Hospital | Centralia | Illinois |
United States | Medical University of South Carolina | Charleston | South Carolina |
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 | University of Illinois | Chicago | Illinois |
United States | Marshfield Clinic-Chippewa Center | Chippewa Falls | Wisconsin |
United States | Oncology Hematology Care Inc-Kenwood | Cincinnati | Ohio |
United States | University of Cincinnati Cancer Center-UC Medical Center | Cincinnati | Ohio |
United States | Kaiser Sunnyside Medical Center | Clackamas | Oregon |
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina |
United States | Henry Ford Hematology Oncology - Hayes | Clinton Township | Michigan |
United States | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan |
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
United States | Mercy Hospital | Coon Rapids | Minnesota |
United States | AMG Crystal Lake - Oncology | Crystal Lake | Illinois |
United States | UT Southwestern Simmons Cancer Center - RedBird | Dallas | Texas |
United States | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas |
United States | Carle at The Riverfront | Danville | Illinois |
United States | Sutter Davis Hospital | Davis | California |
United States | Dayton Physician LLC-Miami Valley Hospital North | Dayton | Ohio |
United States | Miami Valley Hospital | Dayton | Ohio |
United States | Miami Valley Hospital North | Dayton | Ohio |
United States | Henry Ford Medical Center-Fairlane | Dearborn | Michigan |
United States | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois |
United States | Decatur Memorial Hospital | Decatur | Illinois |
United States | Northwestern Medicine Cancer Center Kishwaukee | DeKalb | Illinois |
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 | Henry Ford Hospital | Detroit | Michigan |
United States | Illinois CancerCare-Dixon | Dixon | Illinois |
United States | Advocate Good Samaritan Hospital | Downers Grove | Illinois |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Prisma Health Cancer Institute - Easley | Easley | South Carolina |
United States | Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin |
United States | Fairview Southdale Hospital | Edina | Minnesota |
United States | Carle Physician Group-Effingham | Effingham | Illinois |
United States | Crossroads Cancer Center | Effingham | Illinois |
United States | Advocate Sherman Hospital | Elgin | Illinois |
United States | Elmhurst Memorial Hospital | Elmhurst | Illinois |
United States | UPMC Hillman Cancer Center Erie | Erie | Pennsylvania |
United States | Illinois CancerCare-Eureka | Eureka | Illinois |
United States | Parkland Health Center - Farmington | Farmington | Missouri |
United States | UPMC Cancer Center at UPMC Horizon | Farrell | Pennsylvania |
United States | Armes Family Cancer Center | Findlay | Ohio |
United States | Blanchard Valley Hospital | Findlay | Ohio |
United States | Orion Cancer Care | Findlay | Ohio |
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 | UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas |
United States | Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio |
United States | Dayton Physicians LLC-Atrium | Franklin | Ohio |
United States | Palo Alto Medical Foundation-Fremont | Fremont | California |
United States | Unity Hospital | Fridley | Minnesota |
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 | Northwestern Medicine Cancer Center Delnor | Geneva | Illinois |
United States | Aurora Health Care Germantown Health Center | Germantown | Wisconsin |
United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
United States | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina |
United States | Aurora Cancer Care-Grafton | Grafton | Wisconsin |
United States | Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan |
United States | Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan |
United States | Central Care Cancer Center - Great Bend | Great Bend | Kansas |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg | Pennsylvania |
United States | Dayton Physicians LLC-Wayne | Greenville | Ohio |
United States | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina |
United States | Prisma Health Cancer Institute - Faris | Greenville | South Carolina |
United States | Prisma Health Greenville Memorial Hospital | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Prisma Health Cancer Institute - Greer | Greer | South Carolina |
United States | Gulfport Memorial Hospital | Gulfport | Mississippi |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Advocate South Suburban Hospital | Hazel Crest | Illinois |
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 | Loyola Medicine Homer Glen | Homer Glen | Illinois |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | Ben Taub General Hospital | Houston | Texas |
United States | Keck Medicine of USC Huntington Beach | Huntington Beach | California |
United States | IRMC Cancer Center | Indiana | Pennsylvania |
United States | Allegiance Health | Jackson | Michigan |
United States | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina |
United States | McFarland Clinic - Jefferson | Jefferson | Iowa |
United States | Capital Region Southwest Campus | Jefferson City | Missouri |
United States | UPMC-Johnstown/John P. Murtha Regional Cancer Center | Johnstown | Pennsylvania |
United States | Freeman Health System | Joplin | Missouri |
United States | Mercy Hospital Joplin | Joplin | Missouri |
United States | Ascension Borgess Cancer Center | Kalamazoo | Michigan |
United States | Borgess Medical Center | Kalamazoo | Michigan |
United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
United States | West Michigan Cancer Center | Kalamazoo | Michigan |
United States | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin |
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 | AdventHealth Kissimmee | Kissimmee | Florida |
United States | Marshfield Clinic - Ladysmith Center | Ladysmith | Wisconsin |
United States | Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois |
United States | Northwell Health/Center for Advanced Medicine | Lake Success | New York |
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 | 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 | 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 | Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | AMG Libertyville - Oncology | Libertyville | Illinois |
United States | Condell Memorial Hospital | Libertyville | Illinois |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Keck Medicine of USC Koreatown | Los Angeles | California |
United States | Los Angeles County-USC Medical Center | Los Angeles | California |
United States | UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California |
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
United States | Illinois CancerCare-Macomb | Macomb | Illinois |
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 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin |
United States | McFarland Clinic - Marshalltown | Marshalltown | Iowa |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | UPMC Cancer Center at UPMC McKeesport | McKeesport | Pennsylvania |
United States | Rogue Valley Medical Center | Medford | Oregon |
United States | Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Illinois |
United States | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin |
United States | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio |
United States | East Jefferson General Hospital | Metairie | Louisiana |
United States | LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana |
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 | Medical College of Wisconsin | 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 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Memorial Medical Center | Modesto | California |
United States | UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania |
United States | Monticello Cancer Center | Monticello | Minnesota |
United States | UPMC Hillman Cancer Center - Part of Frick Hospital | Mount Pleasant | Pennsylvania |
United States | Good Samaritan Regional Health Center | Mount Vernon | Illinois |
United States | Palo Alto Medical Foundation-Camino Division | Mountain View | California |
United States | Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View | California |
United States | Trinity Health Muskegon Hospital | Muskegon | Michigan |
United States | Arnold Palmer Cancer Center Medical Oncology Norwin | N. Huntingdon | Pennsylvania |
United States | Edward Hospital/Cancer Center | Naperville | Illinois |
United States | UPMC Cancer Center-Natrona Heights | Natrona Heights | Pennsylvania |
United States | UPMC Hillman Cancer Center - New Castle | New Castle | Pennsylvania |
United States | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois |
United States | Louisiana State University Health Science Center | New Orleans | Louisiana |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | University Medical Center New Orleans | New Orleans | Louisiana |
United States | Cancer Center of Western Wisconsin | New Richmond | Wisconsin |
United States | New Ulm Medical Center | New Ulm | Minnesota |
United States | USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California |
United States | Lakeland Hospital Niles | Niles | Michigan |
United States | Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan |
United States | Sutter Cancer Research Consortium | Novato | California |
United States | Henry Ford Medical Center-Columbus | Novi | Michigan |
United States | Cancer Care Center of O'Fallon | O'Fallon | Illinois |
United States | Drexel Town Square Health Center | Oak Creek | Wisconsin |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Nebraska Cancer Specialists/Oncology Hematology West PC - MECC | Omaha | Nebraska |
United States | Nebraska Methodist Hospital | Omaha | Nebraska |
United States | Oncology Associates PC | Omaha | Nebraska |
United States | University of Chicago Medicine-Orland Park | Orland Park | Illinois |
United States | AdventHealth East Orlando | Orlando | Florida |
United States | AdventHealth Medical Group Urology at Orlando | Orlando | Florida |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Orlando Health Cancer Institute | Orlando | Florida |
United States | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin |
United States | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois |
United States | Hope Cancer Care of Nevada-Pahrump | Pahrump | Nevada |
United States | Palo Alto Medical Foundation Health Care | Palo Alto | California |
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
United States | Keck Medical Center of USC Pasadena | Pasadena | California |
United States | Illinois CancerCare-Pekin | Pekin | Illinois |
United States | Illinois CancerCare-Peoria | Peoria | Illinois |
United States | Methodist Medical Center of Illinois | Peoria | Illinois |
United States | Illinois CancerCare-Peru | Peru | Illinois |
United States | Valley Radiation Oncology | Peru | Illinois |
United States | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania |
United States | UPMC-Passavant Hospital | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Clair Hospital Cancer Center | Pittsburgh | Pennsylvania |
United States | UPMC-Saint Margaret | Pittsburgh | Pennsylvania |
United States | UPMC-Shadyside Hospital | Pittsburgh | Pennsylvania |
United States | Edward Hospital/Cancer Center?Plainfield | Plainfield | Illinois |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Fairview Northland Medical Center | Princeton | Minnesota |
United States | Illinois CancerCare-Princeton | Princeton | Illinois |
United States | Aurora Cancer Care-Racine | Racine | Wisconsin |
United States | Spectrum Health Reed City Hospital | Reed City | Michigan |
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 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin |
United States | UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas |
United States | Reid Health | Richmond | Indiana |
United States | North Memorial Medical Health Center | Robbinsdale | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Delbert Day Cancer Institute at PCRMC | Rolla | Missouri |
United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California |
United States | Sutter Roseville Medical Center | Roseville | California |
United States | Sutter Medical Center Sacramento | Sacramento | California |
United States | University of California Davis Comprehensive Cancer Center | Sacramento | California |
United States | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont |
United States | Heartland Regional Medical Center | Saint Joseph | Missouri |
United States | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
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 | 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 | George E Wahlen Department of Veterans Affairs Medical Center | Salt Lake City | Utah |
United States | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah |
United States | University of Utah Sugarhouse Health Center | Salt Lake City | Utah |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | California Pacific Medical Center-Pacific Campus | San Francisco | California |
United States | Mills Health Center | San Mateo | California |
United States | Palo Alto Medical Foundation-Santa Cruz | Santa Cruz | California |
United States | Sutter Pacific Medical Foundation | Santa Rosa | California |
United States | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina |
United States | UPMC Cancer Center at UPMC Northwest | Seneca | Pennsylvania |
United States | Saint Francis Regional Medical Center | Shakopee | Minnesota |
United States | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin |
United States | Henry Ford Macomb Health Center - Shelby Township | Shelby | Michigan |
United States | Phelps Memorial Hospital Center | Sleepy Hollow | New York |
United States | City of Hope South Pasadena | South Pasadena | California |
United States | CoxHealth South Hospital | Springfield | Missouri |
United States | Memorial Medical Center | Springfield | Illinois |
United States | Mercy Hospital Springfield | Springfield | Missouri |
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 | Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin |
United States | Lakeview Hospital | Stillwater | Minnesota |
United States | Missouri Baptist Sullivan Hospital | Sullivan | Missouri |
United States | Aurora Medical Center in Summit | Summit | Wisconsin |
United States | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California |
United States | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri |
United States | Cedars-Sinai Cancer - Tarzana | Tarzana | California |
United States | University of Toledo | Toledo | Ohio |
United States | Munson Medical Center | Traverse City | Michigan |
United States | Dayton Physicians LLC - Troy | Troy | Ohio |
United States | Upper Valley Medical Center | Troy | Ohio |
United States | Banner University Medical Center - Tucson | Tucson | Arizona |
United States | University of Arizona Cancer Center-North Campus | Tucson | Arizona |
United States | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin |
United States | UPMC Cancer Center-Uniontown | Uniontown | Pennsylvania |
United States | City of Hope Upland | Upland | California |
United States | Carle Cancer Center | Urbana | Illinois |
United States | The Carle Foundation Hospital | Urbana | Illinois |
United States | Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California |
United States | Sutter Solano Medical Center/Cancer Center | Vallejo | California |
United States | Ridgeview Medical Center | Waconia | Minnesota |
United States | Saint Joseph Warren Hospital | Warren | Ohio |
United States | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois |
United States | Illinois CancerCare - Washington | Washington | Illinois |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Mercy Hospital Washington | Washington | Missouri |
United States | UPMC Cancer Center-Washington | Washington | Pennsylvania |
United States | Marshfield Clinic-Wausau Center | Wausau | Wisconsin |
United States | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin |
United States | Aurora West Allis Medical Center | West Allis | Wisconsin |
United States | Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin |
United States | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan |
United States | University of Cincinnati Cancer Center-West Chester | West Chester | Ohio |
United States | Methodist West Hospital | West Des Moines | Iowa |
United States | UPMC West Mifflin-Cancer Center Jefferson | West Mifflin | Pennsylvania |
United States | Marshfield Medical Center - Weston | Weston | Wisconsin |
United States | Rice Memorial Hospital | Willmar | Minnesota |
United States | AdventHealth Winter Park | Winter Park | Florida |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota |
United States | Henry Ford Wyandotte Hospital | Wyandotte | Michigan |
United States | Fairview Lakes Medical Center | Wyoming | Minnesota |
United States | University of Michigan Health - West | Wyoming | Michigan |
United States | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington |
United States | Rush-Copley Healthcare Center | Yorkville | Illinois |
United States | Saint Elizabeth Youngstown Hospital | Youngstown | Ohio |
Lead Sponsor | Collaborator |
---|---|
SWOG Cancer Research Network | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Analysis will be intent-to-treat. Evidence suggesting early termination of the trial and a conclusion that the cytoreductive nephrectomy (CN) approach is superior to treatment alone would be if the null hypothesis is rejected at the one-sided 0.005 level. For the second and third interim analyses, the null and alternative hypotheses with respect to survival will be tested, with superiority tested at the one-sided 0.005 level, and futility determined to be met if the (CN versus no CN) hazard ratio is greater than or equal to 1. A proportional hazards model will be fit to estimate the hazard ratio adjusting for the stratification factors as covariates in the model. Will evaluate whether each of the stratification factors are predictive factors of cytoreductive nephrectomy by placing an interaction term corresponding to each stratification factor and treatment arm in the proportional hazards survival model. | From date of randomization to date of death due to any cause, assessed up to 7 years. | |
Secondary | Overall survival in subset who received assigned protocol treatment | Will be included in the proportional hazards regression model adjusting for stratification factors as covariates. | From date of randomization to date of death due to any cause, assessed up to 7 years | |
Secondary | Progression-free survival | A proportional hazards model will be used to compare progression-free survival between arms, adjusting for the stratification factors as covariates. | From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 7 years | |
Secondary | Objective response | Objective response includes all confirmed and unconfirmed partial and complete responses. Baseline will be disease assessment at randomization. Response Evaluation Criteria in Solid Tumors response rates will be evaluated, excluding the primary tumor in the kidney because that disease will be removed in half the participant's post-randomization. Comparison of response rates will be performed using logistic regression with stratification factors as covariates and an indicator for treatment arm. | Up to 7 years | |
Secondary | Change in maximum diameter of primary tumor | Descriptive statistics will be provided including stratified results by treatment regimen received. Potential additional analyses may include assessment of the interaction between change in primary tumor and randomized treatment arm. This will be modeled as an interaction term in the proportional hazards survival model. | From the disease assessment just prior to the start of immunotherapy to the week 12 disease assessment |
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