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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04510597
Other study ID # S1931
Secondary ID NCI-2020-04442
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 8, 2021
Est. completion date July 2033

Study information

Verified date August 2023
Source SWOG Cancer Research Network
Contact Megan Keim, MS
Phone 210-614-8808
Email mkeim@swog.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

PRIMARY OBJECTIVE: I. To compare overall survival in participants with newly diagnosed metastatic renal cell carcinoma who are randomized to receive immune checkpoint inhibitor-based combination treatment plus cytoreductive nephrectomy versus immune checkpoint inhibitor-based combination treatment alone. SECONDARY OBJECTIVES: I. To compare overall survival between arms in the subset who received their assigned protocol treatment. II. To assess complications of nephrectomy and post-randomization drug toxicities. III. To compare objective response rate in metastatic sites between the arms in participants with measurable metastatic disease. IV. To assess change in diameter of primary tumor at week 12 disease assessment in participants who have received pre-randomization treatment. BANKING OBJECTIVE: I. To bank specimens for future correlative studies. OUTLINE: PRE-RANDOMIZATION TREATMENT: Treatment naive patients are assigned to 1 of 3 treatment regimens per standard of care. REGIMEN I: Patients receive nivolumab intravenously (IV) and ipilimumab IV. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV on day 1. Cycles repeat every 2-4 weeks in the absence of disease progression or unacceptable toxicity. REGIMEN II: Patients receive pembrolizumab IV on day 1 and axitinib orally (PO) twice daily (BID) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. REGIMEN III: Patients receive avelumab IV on day 1 and axitinib PO BID on days 1-14. Cycles repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: Some patients may have already completed the standard of care pre-randomization treatment specified above off-trial. RANDOMIZATION TREATMENT: Between 10-14 weeks from the start of on-trial or off-trial pre-randomization treatment, patients are randomized to 1 of 2 arms. ARM I: Patients receive nivolumab IV, pembrolizumab IV, or avelumab IV on day 1. Patients also receive axitinib PO BID. Cycles with nivolumab repeat every 2 or 4 weeks, cycles with pembrolizumab repeat every 3 weeks, and cycles with avelumab repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Within 42 days following randomization, patients undergo radical or partial nephrectomy in addition to nivolumab, pembrolizumab, avelumab, and axitinib as in Arm I in the absence of disease progression or unacceptable toxicity. Axitinib should be stopped at least 24 hours prior to surgery. After completion of trial treatment, patients are followed up every 3 months for the first year, every 6 months for years 2 and 3, and then annually for up to 7 years from randomization.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cytoreductive Nephrectomy
Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
Drug:
Active Comparator
Nivolumab 240 mg IV 1 q 2 weeks OR Nivolumab 480 mg IV 1 q 4 weeks OR Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID OR Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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