AzTrials
AzTrials

Metastatic Renal Cell CarcinomaPhase 2SAMURAINCT05327686

Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial

A Phase 2 study testing Avelumab, Axitinib and Biospecimen Collection in people with Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v8, run by NRG Oncology at 348 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Avelumab, Axitinib and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
348 sitesin 4 countries
Study dates
1 Feb 2023to 15 Jun 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • Patients with planned treatment of all metastatic disease with definitive therapy including either surgery, ablative (non-palliative) doses of radiation, or intervention of some type (definitive interventional radiology techniques) to ALL metastatic sites rendering the patient without extra-renal measurable disease. Patients NOT planned for definitive treatment of all metastatic sites are eligible. Lesions radiated palliatively are not eligible for response assessment
  • Patients with untreated or unstable brain metastases or cranial epidural disease
  • Note: Patients who have been adequately treated with radiotherapy, radiosurgery, or surgery and stable for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator are eligible. Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 4 weeks prior to registration as documented by MRI or CT imaging or deemed stable by clinical investigator
  • Prior radiotherapy to the kidney that would result in overlap of radiation therapy fields treatment of the primary tumor
  • Any systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before registration, note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
  • Severe, active comorbidity defined as follows:
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  • Active autoimmune disease requiring ongoing therapy including systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications daily. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies
  • Active tuberculosis (purified protein derivative [PPD] response without active tuberculosis [TB] is allowed)
  • Uncontrolled hypertension (systolic blood pressure [BP] >= 190 mmHg or diastolic BP > 110 mmHg)
  • Major surgery requiring hospital admission =< 28 days prior to registration
  • Any serious (requiring hospital stay or long term rehab) non-healing wound, ulcer, or bone fracture within 45 days prior to registration
  • Any arterial thrombotic (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial infarction [NSTEMI], cerebrovascular accident [CVA], etc) events within 180 days prior to registration
  • Active New York (NY) Heart Association class 3-4 heart failure symptoms
  • Moderate or severe hepatic impairment (Child-Pugh B or C)
  • Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) within 180 days prior to registration. (Any asymptomatic or treated pulmonary embolism or asymptomatic treated deep venous thrombosis > 30 days prior to registration is allowed)
  • Unstable cardiac arrhythmia within 180 days prior to registration
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration
  • History of or active inflammatory bowel disease
  • Malabsorption syndrome within 45 days prior to registration
  • Pregnancy and individuals unwilling to discontinue nursing. For women of child bearing potential must have a negative pregnancy test =< 45 days prior to registration

Trial locations and contacts

348 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

306 sites in 4 countries

United States300 sites, 265 recruiting

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

    Site Public Contact, 505-272-0530, ZPollock@salud.unm.edu

    Thomas M. Schroeder

    Recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Thomas M. Schroeder

    Recruiting

  • Lovelace Radiation Oncology

    Albuquerque, New Mexico, 87109

    Site Public Contact, 505-272-0530, AYost@nmcca.org

    Thomas M. Schroeder

    Recruiting

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

    Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org

    Daniel W. Kim

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Samir Narayan

    Recruiting

  • Alton Memorial Hospital

    Alton, Illinois, 62002

    Site Public Contact, 618-463-7323

    Hiram A. Gay

    Recruiting

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu

    William C. Jackson

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • PCR Oncology

    Arroyo Grande, California, 93420

    Suspended

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Corbin Eule

    Recruiting

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

    Site Public Contact, 305-674-2625, yenrique@msmc.com

    Debra L. Linzer

    Recruiting

  • UH Seidman Cancer Center at UH Avon Health Center

    Avon, Ohio, 44011

    Site Public Contact, 800-641-2422

    Pedro Barata

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Active, not recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

    Active, not recruiting

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

    Site Public Contact, 225-215-1353, clinicalresearch@marybird.com

    Victor T. Lin

    Recruiting

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

    Site Public Contact, 516-734-8896

    Clary Evans

    Recruiting

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pedro Barata

    Recruiting

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam Olson

    Recruiting

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Harshraj Leuva

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Nataniel H. Lester-Coll

    Recruiting

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Samir Narayan

    Recruiting

  • Beverly Hospital

    Beverly, Massachusetts, 01915

    Active, not recruiting

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

    Site Public Contact, towercancerresearch@toweroncology.com

    Leslie Ballas

    Recruiting

  • MaineHealth Maine Medical Center - Biddeford

    Biddeford, Maine, 04005

    Active, not recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Site Public Contact, 877-726-5130

    Sophia C. Kamran

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Site Public Contact, 617-724-5200

    Bradley A. McGregor

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Bradley A. McGregor

    Recruiting

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Lahey Clinic

    Burlington, Massachusetts, 01805

    Active, not recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Nataniel H. Lester-Coll

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Nataniel H. Lester-Coll

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

    Site Public Contact, 856-325-6757

    Gary Eastwick

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • Duke Cancer Center Cary

    Cary, North Carolina, 27518

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Ryan E. Fecteau

    Recruiting

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Tracy L. Rose

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Harriet B. Eldredge-Hindy

    Recruiting

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

    Active, not recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Claud M. Grigg

    Recruiting

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

    Site Public Contact, 980-442-2000

    Claud M. Grigg

    Recruiting

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

    Site Public Contact, 800-804-9376

    Claud M. Grigg

    Recruiting

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

    Site Public Contact, 800-804-9376

    Claud M. Grigg

    Recruiting

  • Minnesota Oncology Hematology PA-Chaska

    Chaska, Minnesota, 55318

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Sean Sachdev

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Stanley L. Liauw

    Recruiting

  • Northwestern Medicine Cancer Center Old Irving Park

    Chicago, Illinois, 60641

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Sean Sachdev

    Recruiting

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

    Site Public Contact, 513-584-7698, cancer@uchealth.com

    Timothy D. Struve

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Hiram A. Gay

    Recruiting

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

    Site Public Contact, 888-716-9259

    Michael McCormack

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pedro Barata

    Recruiting

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

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

    Active, not recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Gregory B. Biedermann

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Shang-Jui Wang

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

    Site Public Contact, 800-804-9376

    Claud M. Grigg

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Hiram A. Gay

    Recruiting

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Site Public Contact, 855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Stanley L. Liauw

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    Raquibul Hannan

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Raquibul Hannan

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Raquibul Hannan

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Daniel H. Barnett

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • Miami Valley Hospital

    Dayton, Ohio, 45409

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

    Site Public Contact, 248-551-7695

    Daniel J. Krauss

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Sean Sachdev

    Recruiting

  • UCHealth - Cherry Creek

    Denver, Colorado, 80206

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Corbin Eule

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

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

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

    Site Public Contact, 877-204-6081, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Active, not recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Ryan E. Fecteau

    Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • UC San Diego Health System - Encinitas

    Encinitas, California, 92024

    Site Public Contact, 760-536-7700

    Tyler M. Seibert

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Adam Olson

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Site Public Contact, 814-452-5000

    Alexander Helfand

    Recruiting

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Daniel W. Kim

    Recruiting

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

    Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org

    Daniel W. Kim

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

    Suspended

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • Highlands Oncology Group - Fayetteville

    Fayetteville, Arkansas, 72703

    Site Public Contact, 479-872-8100, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

    Site Public Contact, 970-297-6150

    Corbin Eule

    Recruiting

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Corbin Eule

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Raquibul Hannan

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Active, not recruiting

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

    Site Public Contact, 800-804-9376

    Claud M. Grigg

    Recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Sean Sachdev

    Recruiting

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Active, not recruiting

  • Glens Falls Hospital

    Glens Falls, New York, 12801

    Site Public Contact, 518-926-6700

    Nataniel H. Lester-Coll

    Recruiting

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

    Site Public Contact, 312-695-1102

    Sean Sachdev

    Recruiting

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

    Active, not recruiting

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

    Site Public Contact, 312-695-1102

    Sean Sachdev

    Recruiting

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Corbin Eule

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Northwell Health Cancer Institute at Huntington

    Greenlawn, New York, 11740

    Site Public Contact, 516-734-8896

    Clary Evans

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Adam Olson

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

    Site Public Contact, 864-725-4771, nmcgaha@selfregional.org

    Harriet B. Eldredge-Hindy

    Recruiting

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

    Site Public Contact, 717-724-6765, klitchfield@PINNACLEHEALTH.org

    Adam Olson

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

    Site Public Contact, 708-915-4673, clinicaltrials@ingalls.org

    James A. Wallace

    Recruiting

  • Essentia Health-Hayward Clinic

    Hayward, Wisconsin, 54843

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

    Site Public Contact, 570-459-2901, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

    Site Public Contact, 717-531-3779, CTO@hmc.psu.edu

    Joseph A. Miccio

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • Hayworth Cancer Center

    High Point, North Carolina, 27262

    Site Public Contact, 336-802-2500

    Michael McCormack

    Recruiting

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129

    Site Public Contact, 720-848-0650

    Corbin Eule

    Recruiting

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

    Site Public Contact, 954-265-1847, OHR@mhs.net

    Brian A. Pico

    Recruiting

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

    Site Public Contact, 304-399-6566, Christina.Cole@chhi.org

    Toni O. Pacioles

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam Olson

    Recruiting

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

    Site Public Contact, 317-528-7060

    Craig Schneider

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shera Feinstein

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Mark Waddle

    Recruiting

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Alexander Helfand

    Recruiting

  • Kingman Regional Medical Center

    Kingman, Arizona, 86401

    Suspended

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

    Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org

    Collin D. Driscoll

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Tyler M. Seibert

    Recruiting

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848

    Active, not recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Site Public Contact, cancertrials@northwestern.edu

    Sean Sachdev

    Recruiting

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

    Site Public Contact, 516-734-8896

    Clary Evans

    Recruiting

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

    Active, not recruiting

  • Moffitt Cancer Center at Speros

    Land O' Lakes, Florida, 34638

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kareem Rayn

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Samir Narayan

    Recruiting

  • Beebe Medical Center

    Lewes, Delaware, 19958

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Sanjay Maraboyina

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Samir Narayan

    Recruiting

  • UCHealth Lone Tree Health Center

    Lone Tree, Colorado, 80124

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Corbin Eule

    Recruiting

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

    Active, not recruiting

  • The Angeles Clinic and Research Institute - West Los Angeles Office

    Los Angeles, California, 90025

    Site Public Contact, 888-823-5923, ctsucontact@westat.com

    Leslie Ballas

    Recruiting

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu

    Lauren A. Lukas

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451

    Lauren A. Lukas

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Leslie Ballas

    Recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Site Public Contact, 970-203-7083

    Corbin Eule

    Recruiting

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, 53718

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Amy K. Taylor

    Recruiting

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

    Site Public Contact, 800-622-8922, clinicaltrials@cancer.wisc.edu

    Amy K. Taylor

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Daniel H. Barnett

    Recruiting

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam Olson

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    William A. Hall

    Recruiting

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pedro Barata

    Recruiting

  • Mary Bird Perkins Cancer Center - Metairie

    Metairie, Louisiana, 70002

    Site Public Contact, 504-584-6990

    Victor T. Lin

    Recruiting

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

    Active, not recruiting

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

    Active, not recruiting

  • Miami Cancer Institute

    Miami, Florida, 33176

    Site Public Contact, 786-596-2000

    Adeel Kaiser

    Recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Site Public Contact, 305-674-2625, Yvonne.Enriquez@msmc.com

    Debra L. Linzer

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginia, 23114

    Site Public Contact, 804-893-8978, anne_carmellat@bshsi.org

    Joseph D. Pennington

    Recruiting

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    William A. Hall

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

    Site Public Contact, 612-624-2620

    Ian J. Okazaki

    Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • Memorial Medical Center

    Modesto, California, 95355

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Atrium Health Union/LCI-Union

    Monroe, North Carolina, 28112

    Site Public Contact, 980-442-2000

    Claud M. Grigg

    Recruiting

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-858-7746

    Alexander Helfand

    Recruiting

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Adam Olson

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Adam Olson

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • Franciscan Health Mooresville

    Mooresville, Indiana, 46158

    Site Public Contact, 317-834-3603

    Craig Schneider

    Recruiting

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

    Site Public Contact, 914-666-1366, AMellor@northwell.edu

    Clary Evans

    Recruiting

  • Cooper CyberKnife Center

    Mount Laurel, New Jersey, 08054

    Site Public Contact, 855-632-2667, research-cancer@cooperhealth.edu

    Gary Eastwick

    Recruiting

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

    Site Public Contact, research.institute@phci.org

    Timothy R. Wassenaar

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    Samir Narayan

    Recruiting

  • Marshfield Medical Center - Neillsville

    Neillsville, Wisconsin, 54456

    Active, not recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

    Active, not recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Adam Olson

    Recruiting

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Stanley L. Liauw

    Recruiting

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Active, not recruiting

  • Touro Infirmary

    New Orleans, Louisiana, 70115

    Active, not recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

    Site Public Contact, CancerTrials@nyulangone.org

    Anand Mahadevan

    Recruiting

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

    Site Public Contact, 212-434-4460

    Clary Evans

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Daniel Gorovets

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Site Public Contact, 516-734-8896

    Clary Evans

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

    Active, not recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Sean Sachdev

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    William A. Hall

    Recruiting

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

    Site Public Contact, 262-928-7878

    Timothy R. Wassenaar

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Tyler Gunter

    Recruiting

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

    Site Public Contact, 402-559-5600

    Harshraj Leuva

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Harshraj Leuva

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Shera Feinstein

    Recruiting

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Sean Sachdev

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Site Public Contact, 773-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Stanley L. Liauw

    Recruiting

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pedro Barata

    Recruiting

  • Lahey Clinic Peabody

    Peabody, Massachusetts, 01960

    Active, not recruiting

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

    Site Public Contact, 954-265-4325

    Brian A. Pico

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Site Public Contact, 855-776-0015

    Mark Waddle

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Alexander Helfand

    Recruiting

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Site Public Contact, 412-647-2811

    Adam Olson

    Recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Adam Olson

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-578-5000

    Alexander Helfand

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Adam Olson

    Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-621-2334

    Adam Olson

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Adam Olson

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Adam Olson

    Recruiting

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

    Active, not recruiting

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

    Site Public Contact, 800-275-6401, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

    Site Public Contact, NCTNStudyTeam@dm.duke.edu

    Ryan E. Fecteau

    Recruiting

  • University Hospitals Portage Medical Center

    Ravenna, Ohio, 44266

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Pedro Barata

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

    Site Public Contact, 302-291-6730, research@beebehealthcare.org

    Gregory A. Masters

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Site Public Contact, 775-982-5050, Renown-CRD@renown.org

    Suchit H. Patel

    Recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

    Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org

    Bevan Ly

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Raquibul Hannan

    Recruiting

  • Bon Secours Cancer Institute at Reynolds Crossing

    Richmond, Virginia, 23230

    Site Public Contact, 804-893-8978, Anne_caramella@bshsi.org

    Joseph D. Pennington

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    Alfredo I. Urdaneta

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Alfredo I. Urdaneta

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Mark Waddle

    Recruiting

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

    Site Public Contact, 779-696-9378, lkline@uwhealth.org

    Fahrettin Covut

    Recruiting

  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Sutter Roseville Medical Center

    Roseville, California, 95661

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Corewell Health William Beaumont University Hospital

    Royal Oak, Michigan, 48073

    Site Public Contact, 248-551-7695

    Daniel J. Krauss

    Recruiting

  • Moffitt Cancer Center at SouthShore

    Ruskin, Florida, 33570

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kareem Rayn

    Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Tyler M. Seibert

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Steven N. Seyedin

    Recruiting

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

    Active, not recruiting

  • Mills Health Center

    San Mateo, California, 94401

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - Sanford

    Sanford, Maine, 04073

    Active, not recruiting

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

    Active, not recruiting

  • Ridley-Tree Cancer Center

    Santa Barbara, California, 93105

    Site Public Contact, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • Sutter Pacific Medical Foundation

    Santa Rosa, California, 95403

    Site Public Contact, 415-209-2683, clinicalresearch@sutterhealth.org

    Christopher U. Jones

    Recruiting

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

    Active, not recruiting

  • Community Medical Center

    Scranton, Pennsylvania, 18510

    Site Public Contact, 570-703-4768, cancerresearch@geisinger.edu

    Fiori Alite

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Site Public Contact, 206-287-6275, cancerresearch@virginiamason.org

    Huong T. Pham

    Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Adam Olson

    Recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Charles Shideman

    Recruiting

  • Saint Vincent Hospital Cancer Center at Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Matthew L. Ryan

    Recruiting

  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Hiram A. Gay

    Recruiting

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting

  • Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

    Site Public Contact, 914-366-1600

    Clary Evans

    Recruiting

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

    Active, not recruiting

  • Essentia Health-Spooner Clinic

    Spooner, Wisconsin, 54801

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

    Site Public Contact, 479-872-8130, research@hogonc.com

    Joseph T. Beck

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Site Public Contact, 417-269-4520

    Jay W. Carlson

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Hiram A. Gay

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Hiram A. Gay

    Recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Hiram A. Gay

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

Other trials in United States

Ireland3 sites

  • Beacon Hospital

    Dublin, Co Dublin, 18

    Suspended

  • Saint Lukes Hospital

    Dublin, Co Dublin, 6

    Suspended

  • University College Hospital Galway

    Galway, Co Galway

    Suspended

Other trials in Ireland

Canada2 sites

  • CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

    Québec, Quebec, G1R 2J6

    Suspended

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

    Suspended

Other trials in Canada

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Suspended

Other trials in Australia

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine whether the addition of stereotactic ablative radiotherapy (SABR) to the primary tumor in combination with immunotherapy improves outcomes compared to immunotherapy alone in patients with metastatic, unresected, renal cell carcinoma (RCC). The primary endpoint is nephrectomy and radiographic progression-free survival (nrPFS) with progression determined as per iRECIST criteria.

SECONDARY OBJECTIVES:

  1. To assess the safety, toxicity and tolerability of the two treatment strategies as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5 in each treatment arm.

II. To assess the objective response rate (ORR) by Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in each treatment arm.

III. Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified indications (nephrectomy and radiographic progression-free survival [nrPFS]2).

IV. Radiographic progression-free survival (rPFS). V. To assess overall survival (OS) in each treatment arm. VI. To assess the time to subsequent second-line therapy or death in each treatment arm.

VII. To assess the rate of cytoreductive nephrectomy in each treatment arm. VIII. To assess treatment-free survival in patients who discontinue therapy for reason other than radiographic disease progression.

IX. To assess the ORR by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST in the primary renal mass.

EXPLORATORY OBJECTIVES:

  1. To assess composite nrPFS in the predefined histological subgroups below:

Ia. Clear cell versus non-clear cell histology; Ib. International Metastatic RCC database consortium (IMDC) intermediate versus poor risk group; Ic. Systemic treatment with immunotherapy-immunotherapy combination versus immunotherapy-vascular endothelial growth factor (VEGF) targeted therapy combination; Id. Sarcomatoid versus non sarcomatoid variant. II. To identify prognostic and predictive biomarkers of response to SABR in the context of immunotherapy based treatment via assessment of tissue and blood based biomarkers.

III. To evaluate the abscopal effect of SABR with systemic therapy. IIIa. Compare ORR in non-irradiated target lesions in the control arm patients undergoing immunotherapy alone to the experimental arm undergoing SABR + immunotherapy.

IV. To evaluate the impact of treatment on level of inferior vena cava (IVC) thrombus.

  1. To compare accruing center identified iRECIST progression and centrally identified iRECIST progression events on computed tomography (CT).

OUTLINE: Patients are randomized to 1 of 2 arms. Patients are randomized in a 2:1 ratio favoring the SABR arm.

ARM I: Patients receive one of the following immunotherapy regimens per physician discretion: nivolumab intravenously (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 orally (PO) twice daily (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 once daily (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 computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo a bone scan as clinically indicated and blood sample collection throughout the trial.

ARM II: 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.

After completion of study treatment, patients are followed up every 6 months for 5 years, and then annually for 3 years.

Being tested
Avelumab, Axitinib, Biospecimen Collection, Bone Scan, Cabozantinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • AvelumabBiological

    Also called Bavencio, MSB 0010718C, MSB-0010718C, MSB0010718C

    Given IV

  • AxitinibDrug

    Also called AG 013736, AG-013736, AG013736, Inlyta

    Given PO

  • Biospecimen CollectionProcedure or surgery

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

    Undergo collection of blood

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo bone scan

  • CabozantinibDrug

    Given PO

  • Computed TomographyProcedure or surgery

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

    Undergo CT

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • LenvatinibDrug

    Also called E 7080, E-7080, E7080, ER-203492-00

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

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

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Stereotactic Ablative RadiotherapyRadiation

    Also called SABER, SABR/SBRT

    42 Gy in 3 fractions

Study groups in NCT05327686
Study groupRoleWhat they receive
Arm I (standard of care immunotherapy)Active comparatorPatients 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.
Receives: Biological: Avelumab; Drug: Axitinib; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabozantinib; Procedure: Computed Tomography; Biological: Ipilimumab; Drug: Lenvatinib; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Biological: Pembrolizumab
Arm II (SABR, standard of care immunotherapy)ExperimentalPatients 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.
Receives: Biological: Avelumab; Drug: Axitinib; Procedure: Biospecimen Collection; Procedure: Bone Scan; Drug: Cabozantinib; Procedure: Computed Tomography; Biological: Ipilimumab; Drug: Lenvatinib; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Biological: Pembrolizumab; Radiation: Stereotactic Ablative Radiotherapy

What is being measured

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

  1. Nephrectomy and radiographic progression-free survival (nrPFS)

    Nephrectomy and radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, nephrectomy, death, or last negative evaluation (censored). nrPFS rates are estimated using the Kaplan-Meier method. Progression is determined by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria modified for immunotherapy trials (iRECIST).

    Measured: From randomization to last follow-up, up to 8 years

Secondary outcomes (9)

  1. Percentage of participants with complete or partial response

    Best overall response is determined by the iRECIST version 1.1.

    Measured: From randomization to disease progression

  2. Percentage of participants with complete or partial response in the primary renal mass

    Best overall response is determined by the iRECIST version 1.1.

    Measured: From randomization to disease progression

  3. Radiographic progression-free survival (rPFS)

    Radiographic progression-free survival time is defined as time from randomization to the date of first radiographic progression, death, or last negative evaluation (censored). rPFS rates are estimated using the Kaplan-Meier method. Radiographic progression is determined by the iRECIST version 1.1.

    Measured: From randomization to last follow-up, up to 8 years

  4. Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2)

    Nephrectomy and radiographic progression-free survival time (excluding nephrectomies that were performed for non-protocol specified reasons) is defined as time from randomization to the date of first radiographic progression, nephrectomy performed for protocol-stated reasons, death, or last negative evaluation (censored). nrPFS2 rates are estimated using the Kaplan-Meier method. Progression is determined by the iRECIST version 1.1.

    Measured: From randomization to last follow-up, up to 8 years

  5. Overall survival

    Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method.

    Measured: From randomization to last follow-up, up to 8 years

  6. Second-line therapy-free survival

    Second-line therapy-free survival time is defined as time from randomization to the date of the initiation of second-line therapy, death, or last known follow-up (censored). Second-line therapy-free survival rates are estimated using the Kaplan-Meier method.

    Measured: From randomization to last follow-up, up to 8 years

  7. Percentage of participants who undergo cytoreductive nephrectomy

    Measured: From randomization to last follow-up, up to 8 years

  8. Treatment-free survival

    Treatment-free survival time is defined as time from the discontinuation of protocol therapy to the date of death or last follow-up (censored). Treatment-free survival rates are estimated using the Kaplan-Meier method.

    Measured: From randomization to last follow-up, up to 8 years

  9. Percentage of participants with adverse events

    Common Terminology Criteria for Adverse Events 5.0 grades adverse event severity from 1=mild to 5=death.

    Measured: From randomization to last follow-up, up to 8 years

Timeline

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

  1. First posted14 Apr 2022
  2. Study start1 Feb 2023
  3. Primary completion15 Jun 2028 (estimated)
  4. Study completion15 Jun 2033 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327686
Sponsor's protocol ID
NRG-GU012
Other IDs
NCI-2022-02189, NRG-GU012, NRG-GU012, U10CA180868
Acronym
SAMURAI
Status last verified
Oct 2026
First submitted
7 Apr 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab, Axitinib and Biospecimen Collection in people with Metastatic Renal Cell Carcinoma and Stage III Renal Cell Cancer AJCC v8, run by NRG Oncology at 348 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 348 sites in United States, Ireland, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nephrectomy and radiographic progression-free survival (nrPFS) (time frame: From randomization to last follow-up, up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327686.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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