Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI)

Status: Recruiting
Location: See all (258) locations...
Intervention Type: Procedure, Biological, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR), in combination with standard of care immunotherapy improves outcomes in patients with renal cell cancer that is not recommended for surgery and has spread from where it first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses of radiation over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, avelumab, and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving SABR in combination with standard of care immunotherapy may help shrink or stabilize the cancer in patients with renal cell cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma prior to registration

• Node-positive unresectable (TxN1Mx) or metastatic (TxNxM1) based on the following diagnostic workup:

‣ History/physical examination within 45 days prior to registration

⁃ CT/magnetic resonance imaging (MRI) of the chest/abdomen/pelvis within 45 days prior to registration

• Patients must have IMDC intermediate (1-2 factors) or poor risk disease (\>= 3 factors)

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

• Patients with measurable disease (node positive or metastatic) as defined by RECIST version 1.1 excluding the primary renal tumor

• Patient not recommended for or refused immediate cytoreductive nephrectomy

• Candidate for standard of care therapy with either immuno-oncology (IO)-IO or IO-VEGF combination regimen

• Primary renal tumor measuring 20 cm or less in anterior to posterior dimension only on axial imaging

• Age \>= 18

• Karnofsky performance status \>= 60 within 45 days prior to registration

• Hemoglobin \>= 8 g/dL (transfusions are allowed) (within 45 days prior to registration)

• Platelet count \>= 50,000/mm\^3 (within 45 days prior to registration)

• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (within 45 days prior to registration)

• Calculated (Calc.) creatinine clearance \>= 30 mL/min (within 45 days prior to registration)

‣ Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault Equation

⁃ For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR \>= 30 mL/min/1.73m\^2 will be considered adequate

• Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) (within 45 days prior to registration)

• Aspartate aminotransferase and alanine aminotransferase (AST and ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if hepatic metastases present (within 45 days prior to registration)

• Patients with known human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Testing is not required for entry into protocol

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load

• The patient must agree to use a highly effective contraception, including men with vasectomies if they are having sex with a woman of childbearing potential or with a woman who is pregnant, while on study drug and for 6 months following the last dose of study drug. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
PCR Oncology
RECRUITING
Arroyo Grande
Mills-Peninsula Medical Center
RECRUITING
Burlingame
City of Hope Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Duarte
UC San Diego Health System - Encinitas
RECRUITING
Encinitas
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING
Irvine
UC San Diego Moores Cancer Center
RECRUITING
La Jolla
Memorial Medical Center
RECRUITING
Modesto
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Sutter Cancer Centers Radiation Oncology Services-Roseville
RECRUITING
Roseville
Sutter Roseville Medical Center
RECRUITING
Roseville
Sutter Medical Center Sacramento
RECRUITING
Sacramento
UC San Diego Medical Center - Hillcrest
RECRUITING
San Diego
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Pacific Central Coast Health Center-San Luis Obispo
ACTIVE_NOT_RECRUITING
San Luis Obispo
Mills Health Center
RECRUITING
San Mateo
Ridley-Tree Cancer Center
RECRUITING
Santa Barbara
Sutter Pacific Medical Foundation
RECRUITING
Santa Rosa
Colorado
UCHealth University of Colorado Hospital
RECRUITING
Aurora
UCHealth - Cherry Creek
RECRUITING
Denver
Cancer Care and Hematology-Fort Collins
RECRUITING
Fort Collins
Poudre Valley Hospital
RECRUITING
Fort Collins
UCHealth Greeley Hospital
RECRUITING
Greeley
UCHealth Highlands Ranch Hospital
RECRUITING
Highlands Ranch
UCHealth Lone Tree Health Center
RECRUITING
Lone Tree
Medical Center of the Rockies
RECRUITING
Loveland
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Mayo Clinic in Florida
RECRUITING
Jacksonville
Miami Cancer Institute
RECRUITING
Miami
Mount Sinai Medical Center
RECRUITING
Miami Beach
Memorial Hospital West
RECRUITING
Pembroke Pines
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Iowa Methodist Medical Center
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Illinois
Alton Memorial Hospital
RECRUITING
Alton
Centralia Oncology Clinic
RECRUITING
Centralia
Northwestern University
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING
Dekalb
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Northwestern Medicine Cancer Center Delnor
RECRUITING
Geneva
Northwestern Medicine Glenview Outpatient Center
RECRUITING
Glenview
Northwestern Medicine Grayslake Outpatient Center
RECRUITING
Grayslake
Northwestern Medicine Lake Forest Hospital
RECRUITING
Lake Forest
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
UW Health Carbone Cancer Center Rockford
RECRUITING
Rockford
Memorial Hospital East
RECRUITING
Shiloh
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
The Carle Foundation Hospital
RECRUITING
Urbana
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Louisiana
Louisiana Hematology Oncology Associates LLC
RECRUITING
Baton Rouge
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
East Jefferson General Hospital
ACTIVE_NOT_RECRUITING
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
ACTIVE_NOT_RECRUITING
Metairie
Mary Bird Perkins Cancer Center - Metairie
RECRUITING
Metairie
Louisiana State University Health Science Center
ACTIVE_NOT_RECRUITING
New Orleans
Touro Infirmary
ACTIVE_NOT_RECRUITING
New Orleans
University Medical Center New Orleans
ACTIVE_NOT_RECRUITING
New Orleans
Massachusetts
Beverly Hospital
RECRUITING
Beverly
Brigham and Women's Hospital
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Lahey Hospital and Medical Center
RECRUITING
Burlington
Addison Gilbert Hospital
RECRUITING
Gloucester
Lahey Medical Center-Peabody
RECRUITING
Peabody
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
ACTIVE_NOT_RECRUITING
Winchester
Maryland
University of Maryland/Greenebaum Cancer Center
ACTIVE_NOT_RECRUITING
Baltimore
Central Maryland Radiation Oncology in Howard County
ACTIVE_NOT_RECRUITING
Columbia
UM Baltimore Washington Medical Center/Tate Cancer Center
ACTIVE_NOT_RECRUITING
Glen Burnie
Maine
MaineHealth Coastal Cancer Treatment Center
ACTIVE_NOT_RECRUITING
Bath
MaineHealth Maine Medical Center - Biddeford
ACTIVE_NOT_RECRUITING
Biddeford
MaineHealth Maine Medical Center - Portland
ACTIVE_NOT_RECRUITING
Portland
MaineHealth Cancer Care and IV Therapy - Sanford
ACTIVE_NOT_RECRUITING
Sanford
MaineHealth Cancer Care Center of York County
ACTIVE_NOT_RECRUITING
Sanford
MaineHealth Maine Medical Center- Scarborough
ACTIVE_NOT_RECRUITING
Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland
ACTIVE_NOT_RECRUITING
South Portland
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
University of Michigan Comprehensive Cancer Center
RECRUITING
Ann Arbor
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Corewell Health Dearborn Hospital
RECRUITING
Dearborn
Corewell Health Farmington Hills Hospital
RECRUITING
Farmington Hills
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Corewell Health William Beaumont University Hospital
RECRUITING
Royal Oak
Corewell Health Beaumont Troy Hospital
RECRUITING
Troy
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Saint Mary's Medical Center
RECRUITING
Duluth
Miller-Dwan Hospital
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Hennepin County Medical Center
RECRUITING
Minneapolis
Mayo Clinic in Rochester
RECRUITING
Rochester
Regions Hospital
RECRUITING
Saint Paul
Essentia Health Sandstone
RECRUITING
Sandstone
Lakeview Hospital
RECRUITING
Stillwater
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
City Of Saint Peters
MU Health - University Hospital/Ellis Fischel Cancer Center
RECRUITING
Columbia
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
Mercy Hospital Springfield
RECRUITING
Springfield
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
RECRUITING
St Louis
Siteman Cancer Center-South County
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Atrium Health Pineville/LCI-Pineville
RECRUITING
Charlotte
Atrium Health University City/LCI-University
RECRUITING
Charlotte
Carolinas Medical Center/Levine Cancer Institute
RECRUITING
Charlotte
Levine Cancer Institute-Ballantyne
RECRUITING
Charlotte
Wake Forest University at Clemmons
RECRUITING
Clemmons
Atrium Health Cabarrus/LCI-Concord
RECRUITING
Concord
Duke University Medical Center
RECRUITING
Durham
Levine Cancer Institute-Gaston
RECRUITING
Gastonia
Hayworth Cancer Center
RECRUITING
High Point
Atrium Health Union/LCI-Union
RECRUITING
Monroe
Wake Forest Baptist Health - Wilkes Medical Center
RECRUITING
Wilkesboro
Wake Forest University Health Sciences
RECRUITING
Winston-salem
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
Nebraska
Nebraska Medicine-Bellevue
RECRUITING
Bellevue
Nebraska Medicine-Village Pointe
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Cooper Hospital University Medical Center
RECRUITING
Camden
Monmouth Medical Center Southern Campus
RECRUITING
Lakewood
Monmouth Medical Center
RECRUITING
Long Branch
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
Cooper CyberKnife Center
RECRUITING
Mount Laurel
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Rutgers New Jersey Medical School
RECRUITING
Newark
Community Medical Center
RECRUITING
Toms River
New Mexico
Lovelace Medical Center-Saint Joseph Square
RECRUITING
Albuquerque
Lovelace Radiation Oncology
RECRUITING
Albuquerque
New York
Memorial Sloan Kettering Commack
RECRUITING
Commack
Glens Falls Hospital
RECRUITING
Glens Falls
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Stony Brook University Medical Center
ACTIVE_NOT_RECRUITING
Stony Brook
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Ohio
UH Seidman Cancer Center at UH Avon Health Center
RECRUITING
Avon
UHHS-Chagrin Highlands Medical Center
RECRUITING
Beachwood
Dayton Physicians LLC-Miami Valley South
RECRUITING
Centerville
Miami Valley Hospital South
RECRUITING
Centerville
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING
Cincinnati
Case Western Reserve University
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Dayton Physician LLC - Englewood
RECRUITING
Dayton
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Dayton Physicians LLC-Atrium
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
UH Seidman Cancer Center at Lake Health Mentor Campus
RECRUITING
Mentor
University Hospitals Parma Medical Center
RECRUITING
Parma
University Hospitals Portage Medical Center
RECRUITING
Ravenna
Upper Valley Medical Center
RECRUITING
Troy
University of Cincinnati Cancer Center-West Chester
RECRUITING
West Chester
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oklahoma Cancer Specialists and Research Institute-Tulsa
RECRUITING
Tulsa
Pennsylvania
Lehigh Valley Hospital-Cedar Crest
RECRUITING
Allentown
UPMC-Heritage Valley Health System Beaver
RECRUITING
Beaver
Lehigh Valley Hospital - Muhlenberg
RECRUITING
Bethlehem
Carlisle Regional Cancer Center
RECRUITING
Carlisle
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITING
Greensburg
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
RECRUITING
Harrisburg
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
RECRUITING
Mechanicsburg
UPMC Hillman Cancer Center - New Castle
RECRUITING
New Castle
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
UPMC-Magee Womens Hospital
RECRUITING
Pittsburgh
UPMC-Passavant Hospital
RECRUITING
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
RECRUITING
Pittsburgh
UPMC-Saint Margaret
RECRUITING
Pittsburgh
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
Reading Hospital
RECRUITING
West Reading
Divine Providence Hospital
RECRUITING
Williamsport
UPMC Memorial
RECRUITING
York
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Self Regional Healthcare
RECRUITING
Greenwood
South Dakota
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Texas
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Virginia
Bon Secours Saint Francis Medical Center
RECRUITING
Midlothian
Bon Secours Cancer Institute at Reynolds Crossing
RECRUITING
Richmond
Vermont
Central Vermont Medical Center/National Life Cancer Treatment
RECRUITING
Berlin Corners
University of Vermont and State Agricultural College
RECRUITING
Burlington
University of Vermont Medical Center
RECRUITING
Burlington
Washington
Virginia Mason Medical Center
RECRUITING
Seattle
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
Duluth Clinic Ashland
RECRUITING
Ashland
Northwest Wisconsin Cancer Center
RECRUITING
Ashland
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Essentia Health-Hayward Clinic
RECRUITING
Hayward
Marshfield Medical Center - Ladysmith
ACTIVE_NOT_RECRUITING
Ladysmith
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITING
Madison
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Froedtert Menomonee Falls Hospital
RECRUITING
Menomonee Falls
Medical College of Wisconsin
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
Marshfield Medical Center - Neillsville
ACTIVE_NOT_RECRUITING
Neillsville
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Drexel Town Square Health Center
RECRUITING
Oak Creek
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Essentia Health-Spooner Clinic
RECRUITING
Spooner
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Essentia Health Saint Mary's Hospital - Superior
RECRUITING
Superior
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
Aspirus Regional Cancer Center
RECRUITING
Wausau
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING
West Bend
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
ACTIVE_NOT_RECRUITING
Wisconsin Rapids
West Virginia
West Virginia University Charleston Division
RECRUITING
Charleston
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
Other Locations
Australia
Peter MacCallum Cancer Centre
RECRUITING
Melbourne
Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
SUSPENDED
Québec
University Health Network-Princess Margaret Hospital
SUSPENDED
Toronto
Ireland
Beacon Hospital
RECRUITING
Dublin
Saint Lukes Hospital
RECRUITING
Dublin
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 240
Treatments
Active_comparator: Arm I (standard of care immunotherapy)
Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes every 3 weeks for 4 doses followed by nivolumab IV over 30 minutes every 2 or 4 weeks; pembrolizumab IV over 30 minutes every 3 or 6 weeks and axitinib PO BID; avelumab IV over 60 minutes every 2 weeks and axitinib PO BID; nivolumab IV over 30 minutes every 2 or 4 weeks and cabozantinib PO QD; OR pembrolizumab IV over 30 minutes every 3 or 6 weeks and lenvatinib PO QD. Treatment with immunotherapy continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Experimental: Arm II (SABR, standard of care immunotherapy)
Patients undergo SABR on 3 different days over 1-3 weeks and receive immunotherapy as in Arm I. Patients also undergo CT scan or MRI throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.
Related Therapeutic Areas
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov