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631 Study Matches

Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma

ctrrecruit@vcu.edu

PHASE3
NCT05256225
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Inclusion Criteria:
* Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IVB, non-recurrent, chemotherapy (chemo)-naive, HER2-positive endometrial cancer. The following endometrial cancer types are eligible: * Serous * Other endometrial cancers (including clear cell, endometrioid, mixed epithelial, dedifferentiated/undifferentiated) * Carcinosarcoma * NOTE: Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible * Histologic confirmation of the original primary tumor is required. Submission of surgical pathology report (or endometrial biopsy pathology report in patients who never undergo hysterectomy) is required * Patients must be within 8 weeks of primary surgery (or endometrial biopsy in patients who never undergo hysterectomy) at the time of study registration * Patients may have measurable disease, non-measurable disease, or no measurable disease. In patients with measurable disease, lesions will be defined and monitored by RECIST v 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \>= 10 mm when measured by CT or magnetic resonance imaging (MRI). Lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI * For patients with uterine-confined (stage I) disease, the tumor must be invasive into the myometrium. Any amount of myoinvasion is acceptable for eligibility. Patients with non-invasive disease, endometrial intraepithelial carcinoma alone, or disease confined to a polyp will be excluded * All patients must have tumors that are HER2 positive as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 Breast Cancer guidelines (https://documents.cap.org/documents/algorithim-evaluation-her2.pdf.) IHC and ISH testing will be done locally, at each participating institution and interpreted by local pathologists. In general HER2 positivity is defined as any of the following: * 3+ immunohistochemistry (IHC), * 2+ IHC with positive in situ hybridization (ISH) Alternatively, patients could be eligible if next generation sequencing (NGS) demonstrates HER2 (ERBB2) amplification. NGS testing can be performed through any designated labs as per the National Cancer Institute (NCI) MATCH/NCI Combo-MATCH trial (https://ecog-acrin.org/nci-match-eay131-designated-labs). Pathology report showing results of institutional HER2 testing (or NGS testing results) must be submitted. Sites must submit all results available (IHC, ISH, and NGS) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Age \>= 18 * Platelets \>= 100,000/mcl (within 14 days prior to registration) * Absolute neutrophil count (ANC) \>= 1,500/mcl (within 14 days prior to registration) * Creatinine =\< 1.5 x institutional/laboratory upper limit of normal (ULN) or estimated Glomerular filtration rate (eGFR) \>= 50 mL/min using either the Cockcroft-Gault equation, the Modification of Diet in Renal Disease Study, or as reported in the comprehensive metabolic panel/basic metabolic panel (eGFR) (within 14 days prior to registration) * Total serum bilirubin level =\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\< 3 x ULN may be enrolled) (within 14 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN (within 14 days prior to registration) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * Although the uterus will have been removed in the vast majority of patients, for patients of child-bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. Patients will be considered of non-reproductive potential if they are either: * Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age, a high follicle stimulating hormone \[FSH\] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR * Have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion at least 6 weeks prior to registration * Have a congenital or acquired condition that prevents childbearing * 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 evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression * 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
Exclusion Criteria:
* Prior Therapy: * Patients must NOT have received prior chemotherapy, biologic therapy, or targeted therapy for treatment of endometrial carcinoma * Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy * NOTE: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration * Patients may have received prior hormonal therapy for treatment of endometrial carcinoma. All hormonal therapy must be discontinued at least one week prior to registration * Patients may not have a planned interval cytoreduction or hysterectomy, prior to documentation of progression, after study registration * Patients may not have planned external beam radiotherapy, prior to documentation of progression, after study registration * Significant cardiovascular disease including: * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg despite antihypertensive medications * Myocardial infarction or unstable angina within 6 months prior to registration * New York Heart Association functional classification II, III or IV * Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate * Significant lung disease: dyspnea at rest grade 2 or greater (resulting from extensive tumor involvement or other causes), pneumonitis grade 2 or greater, interstitial lung disease grade 2 or greater, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia) * Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), uncontrolled interstitial lung disease, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements * Treatment with strong CYP2C8 or CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to registration * Women who are unwilling to discontinue nursing
PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, RADIATION: High-Dose-Rate Vaginal Cuff Brachytherapy, DRUG: Hyaluronidase-zzxf/Pertuzumab/Trastuzumab, PROCEDURE: Multigated Acquisition Scan, DRUG: Paclitaxel, OTHER: Survey Administration, DRUG: Trastuzumab/Hyaluronidase-oysk
Endometrial Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Uterine Corpus Carcinosarcoma
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
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Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
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Aultman Health Foundation Canton, Ohio Site Public Contact - (ClinicalReserachDept@aultman.com)
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Legacy Meridian Park Hospital Tualatin, Oregon
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Saint Elizabeth Healthcare Edgewood Edgewood, Kentucky Site Public Contact - (Kristi.Curtsinger@stelizabeth.com)
Saint Joseph Hospital - Orange Orange, California
Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina Site Public Contact - (underberga@sjchs.org)
Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania
Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.org)
Saint Rita's Medical Center Lima, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Vincent Frontier Cancer Center Billings, Montana
Saint Vincent Hospital Erie, Pennsylvania
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Samsung Changwon Hospital Seoul, Gyeongsangnam-do
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Sarasota Memorial Hospital Sarasota, Florida
Sarasota Memorial Hospital-Venice N. Venice, Florida
Sheboygan Physicians Group Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sibley Memorial Hospital Washington D.C., District of Columbia Site Public Contact - (jquiver1@jhmi.edu)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
South Jordan Health Center South Jordan, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ohio Medical Center Portsmouth, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Springfield Regional Cancer Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Springfield Regional Medical Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Sudarshan K Sharma MD Limited-Gynecologic Oncology Hinsdale, Illinois
Sutter Auburn Faith Hospital Auburn, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Roseville Medical Center Roseville, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Tarrant County Hospital District/JPS Health Network Fort Worth, Texas Site Public Contact - (macosta02@jpshealth.org)
The Community Hospital Munster, Indiana
The Mark H Zangmeister Center Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
The West Clinic - Wolf River Germantown, Tennessee
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UCHealth - Cherry Creek Denver, Colorado Site Public Contact - (Roster@nrgoncology.org)
UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado
UCHealth University of Colorado Hospital Aurora, Colorado
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UH Seidman Cancer Center at Saint John Medical Center Westlake, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UHHS-Chagrin Highlands Medical Center Beachwood, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas
UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
UW Cancer Center at ProHealth Care Waukesha, Wisconsin Site Public Contact - (Chanda.miller@phci.org)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Site Public Contact - (tmyrick@uab.edu)
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of Arkansas for Medical Sciences Little Rock, Arkansas
University of California Davis Comprehensive Cancer Center Sacramento, California
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University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas at Austin Austin, Texas Site Public Contact - (irb@austin.utexas.edu)
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
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Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Virtua Samson Cancer Center Moorestown, New Jersey
Virtua Voorhees Voorhees Township, New Jersey
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Weisberg Cancer Treatment Center Farmington Hills, Michigan Site Public Contact - (ctoadmin@karmanos.org)
West Jefferson Medical Center Marrero, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Penn Hospital Pittsburgh, Pennsylvania
West Virginia University Charleston Division Charleston, West Virginia
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Wexford Health and Wellness Pavilion Wexford, Pennsylvania
William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland
Women and Infants Hospital Providence, Rhode Island
Women's Cancer Care Associates LLC Albany, New York Site Public Contact - (jbarlin@womenscancercareassociates.com)
Women's Cancer Center of Nevada Las Vegas, Nevada
Women's Diagnostic Center - Munster Munster, Indiana Site Public Contact - (mnicholson@comhs.org)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY_HCM)

BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com

Phase 3
NCT05582395
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Inclusion Criteria:

• Diagnosis of HCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines: unexplained left-ventricular hypertrophy with non-dilated ventricular chambers in the absence of other cardiac or systemic disease which can produce the required magnitude of hypertrophy of a maximal left ventricular (LV) wall thickness ≥ 15 millimeters (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy [HCM]) as determined by core laboratory interpretation
• Peak left ventricular outflow tract (LVOT) pressure gradient < 30 millimeters mercury (mm Hg) at rest and < 50 mm Hg with provocation (Valsalva maneuver and stress echocardiography)
• New York Heart Association (NYHA) Class II or III
Exclusion Criteria:

• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics non-obstructive hypertrophic cardiomyopathy (nHCM) such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy
• History of unexplained syncope within 6 months prior to screening
• History of sustained ventricular tachyarrhythmia (> 30 seconds) within 6 months prior to screening Additional inclusion and exclusion criteria apply.
Drug: Mavacamten, Other: Placebo
Cardiomyopathy, Hypertrophic
Mavacamten, non-obstructive HCM, non-obstructive hypertrophic cardiomyopathy (nHCM)
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Show 197 locations

Study Locations

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Location Contacts
Baylor Scott and White Research Institute Dallas, Texas Robert Gottlieb, Site 0089
Carolinas HealthCare System Charlotte, North Carolina John Symanski, Site 0094
Cedars-Sinai Heart Institute Los Angeles, California Florian Rader, Site 0010
Cleveland Clinic Ohio - 9500 Euclid Ave Cleveland, Ohio Milind Desai, Site 0083
Duke University Health System Durham, North Carolina Andrew Wang, Site 0065
Emory University Hospital Atlanta, Georgia Ozlem Bilen, Site 0092
Henry Ford Hospital Detroit, Michigan Karthikeyan Ananthasubramaniam, Site 0064
Indiana University School of Medicine-Indianapolis Indianapolis, Indiana Roopa Rao, Site 0424
Johns Hopkins University Baltimore, Maryland Jose Madrazo, Site 0127
Lancaster General Hospital Lancaster, Pennsylvania Robert Donovan, Site 0444
Local Institution - 0001 Lenexa, Kansas Site 0001
Local Institution - 0003 Oakland, California Site 0003
Local Institution - 0004 East Sussex, Brighton And Hove Site 0004
Local Institution - 0005 Leeds, Site 0005
Local Institution - 0006 São Paulo, Site 0006
Local Institution - 0008 Munster, Northwest Site 0008
Local Institution - 0009 Greenville, South Carolina Site 0009
Local Institution - 0011 Austin, Texas Site 0011
Local Institution - 0012 Lima, Site 0012
Local Institution - 0013 Tyler, Texas Site 0013
Local Institution - 0014 Antwerpen, VAN Site 0014
Local Institution - 0015 Boston, Massachusetts Site 0015
Local Institution - 0016 Lima, LIM Site 0016
Local Institution - 0017 Atlanta, Georgia Site 0017
Local Institution - 0018 Seattle, Washington Site 0018
Local Institution - 0019 Atlanta, Georgia Site 0019
Local Institution - 0021 La Jolla, California Site 0021
Local Institution - 0022 Lima, LIM Site 0022
Local Institution - 0023 Napoli, Site 0023
Local Institution - 0024 Boston, Massachusetts Site 0024
Local Institution - 0025 New York, New York Site 0025
Local Institution - 0026 New York, New York Site 0026
Local Institution - 0027 New Orleans, Louisiana Site 0027
Local Institution - 0028 Salt Lake City, Utah Site 0028
Local Institution - 0030 Córdoba, VER Site 0030
Local Institution - 0031 Guangzhou, Guangdong Site 0031
Local Institution - 0032 Pittsburgh, Pennsylvania Site 0032
Local Institution - 0033 Towson, Maryland Site 0033
Local Institution - 0034 Chicago, Illinois Site 0034
Local Institution - 0035 New York, New York Site 0035
Local Institution - 0037 Bruxelles, Pl-mz Site 0037
Local Institution - 0038 Leuven, Site 0038
Local Institution - 0039 Zuerich, Site 0039
Local Institution - 0040 Evanston, Illinois Site 0040
Local Institution - 0041 St.Gallen, HE Site 0041
Local Institution - 0042 Austin, Texas Site 0042
Local Institution - 0043 Changchun, Jilin Site 0043
Local Institution - 0044 Lima, Site 0044
Local Institution - 0045 Louisville, Kentucky Site 0045
Local Institution - 0046 Münster, Site 0046
Local Institution - 0048 Seattle, Washington Site 0048
Local Institution - 0049 Jackson, Mississippi Site 0049
Local Institution - 0050 Bedford Park, South Australia Site 0050
Local Institution - 0051 Sevilla, MZ Site 0051
Local Institution - 0052 Mainz, Rheinland-Pfalz Site 0052
Local Institution - 0053 Burlington, Ontario Site 0053
Local Institution - 0054 Tübingen, Site 0054
Local Institution - 0055 Lima, Site 0055
Local Institution - 0056 Berlin, Site 0056
Local Institution - 0057 Hannover, Site 0057
Local Institution - 0059 Los Angeles, California Site 0059
Local Institution - 0060 Gainesville, Florida Site 0060
Local Institution - 0061 Utrecht, Site 0061
Local Institution - 0062 Detroit, Michigan Site 0062
Local Institution - 0063 Brno, JM Site 0063
Local Institution - 0066 Massillon, Ohio Site 0066
Local Institution - 0067 Hackensack, New Jersey Site 0067
Local Institution - 0069 Boston, Massachusetts Site 0069
Local Institution - 0071 L'Hospitalet Del Llobregat, Barcelona [Barcelona] Site 0071
Local Institution - 0072 Madrid, Site 0072
Local Institution - 0073 Dallas, Texas Site 0073
Local Institution - 0074 Montpellier, Languedoc-Roussillon Site 0074
Local Institution - 0075 Chengdu, Sichuan Site 0075
Local Institution - 0076 Bedzin, Site 0076
Local Institution - 0077 New Brunswick, New Jersey Site 0077
Local Institution - 0078 Monterrey, Nuevo León Site 0078
Local Institution - 0080 Providencia, RM Site 0080
Local Institution - 0085 Washington D.C., District of Columbia Site 0085
Local Institution - 0086 Linz, Site 0086
Local Institution - 0087 Richmond, Virginia Site 0087
Local Institution - 0090 Brisbane, Queensland Site 0090
Local Institution - 0091 Nice, Site 0091
Local Institution - 0093 Salamanca, Site 0093
Local Institution - 0119 Tokyo, Site 0119
Local Institution - 0160 Budapest, Pest Site 0160
Local Institution - 0168 Kashiwa, Chiba Site 0168
Local Institution - 0171 Kumamoto, Site 0171
Local Institution - 0174 Chapel Hill, North Carolina Site 0174
Local Institution - 0188 Brno, Jihomoravský Kraj Site 0188
Local Institution - 0203 Exeter, South West Site 0203
Local Institution - 0208 Edmonton, Alberta Site 0208
Local Institution - 0213 Seattle, Washington Site 0213
Local Institution - 0217 Sherbrooke, Quebec Site 0217
Local Institution - 0221 Boulogne-Billancourt, Hauts-de-Seine Site 0221
Local Institution - 0224 Gümüşhane, Gümüşhane Province Site 0224
Local Institution - 0237 San Juan, Site 0237
Local Institution - 0253 Melbourne, Victoria Site 0253
Local Institution - 0258 Würzburg, Bayern Site 0258
Local Institution - 0273 Amagasaki, Hyōgo Site 0273
Local Institution - 0289 Tianjin, Tianjin Municipality Site 0289
Local Institution - 0299 Heidelberg,VIC, Victoria Site 0299
Local Institution - 0314 Donostia / San Sebastian, Gipuzkoa Site 0314
Local Institution - 0319 Fukuoka, Site 0319
Local Institution - 0330 Katowice, Silesian Voivodeship Site 0330
Local Institution - 0338 Amsterdam, Site 0338
Local Institution - 0357 Gosford, New South Wales Site 0357
Local Institution - 0369 New York, New York Site 0369
Local Institution - 0370 Essen, Site 0370
Local Institution - 0373 Firenze, Site 0373
Local Institution - 0381 London, LND Site 0381
Local Institution - 0403 Mersin, Site 0403
Local Institution - 0404 Ulm, Site 0404
Local Institution - 0407 Ahmedabad, Gujarat Site 0407
Local Institution - 0411 Mexico City, Mexico City Site 0411
Local Institution - 0412 A Coruña, A Coruña [La Coruña] Site 0412
Local Institution - 0413 Guadalajara, Site 0413
Local Institution - 0414 Nagpur, MH Site 0414
Local Institution - 0415 Zabrze, Slaskie Site 0415
Local Institution - 0416 Phoenix, Arizona Site 0416
Local Institution - 0417 Szeged, Site 0417
Local Institution - 0418 São Paulo, SAO Paulo Site 0418
Local Institution - 0419 Haifa, Site 0419
Local Institution - 0420 Sarıçam, Adana Site 0420
Local Institution - 0421 Buenos Aires, Buenos Aires F.D. Site 0421
Local Institution - 0422 Ankara, Site 0422
Local Institution - 0423 Kitakyushu-shi, Fukuoka Site 0423
Local Institution - 0425 Belo Horizonte, Minas Gerais Site 0425
Local Institution - 0427 Singapore, Central Singapore Site 0427
Local Institution - 0428 Chiang Mai, Site 0428
Local Institution - 0429 Srinagar, Jammu and Kashmir Site 0429
Local Institution - 0430 Kochi, Kerala Site 0430
Local Institution - 0433 New Delhi, Delhi Site 0433
Local Institution - 0434 Bangkok, Bangkok Site 0434
Local Institution - 0436 Edgewood, Kentucky Site 0436
Local Institution - 0437 Kansas City, Missouri Site 0437
Local Institution - 0438 Jeddah, Site 0438
Local Institution - 0439 Boston, Massachusetts Site 0439
Local Institution - 0440 Osijek, Site 0440
Local Institution - 0441 Indianapolis, Indiana Site 0441
Local Institution - 0442 Daegu, Taegu-Kwangyǒkshi Site 0442
Local Institution - 0443 Box Hill, Victoria Site 0443
Local Institution - 0445 Guadalajara, Jalisco Site 0445
Local Institution - 0446 Buenos Aires, Site 0446
Local Institution - 0447 Santiago, Site 0447
Local Institution - 0448 Guadalajara, Jalisco Site 0448
Local Institution - 0450 Heraklion, Iraklio Kritis Site 0450
Local Institution - 0451 Keçiören/Ankara, Site 0451
Local Institution - 0452 Atlanta, Georgia Site 0452
Local Institution - 0453 Lembah Pantai, Kuala Lumpur Site 0453
Local Institution - 0454 Pilea Chortiatis, Thessaloniki Site 0454
Local Institution - 0456 Pasaport, Site 0456
Local Institution - 0457 Nagpur, Maharashtra Site 0457
Local Institution - 0459 Goiânia, Goias Site 0459
Local Institution - 0460 Graz, Styria Site 0460
Local Institution - 0462 Auckland, Site 0462
Local Institution - 0463 Hermosillo, Sonora Site 0463
Local Institution - 0466 Pittsburgh, Pennsylvania Site 0466
Local Institution - 0467 Darlinghurst, New South Wales Site 0467
Local Institution - 0470 Santa Cruz de Tenerife, Site 0470
Local Institution - 0471 Coimbatore, Tamil Nadu Site 0471
Local Institution - 0472 London, Middlesex Site 0472
Local Institution - 0473 Graz, Styria Site 0473
Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui Site 0475
Local Institution - 0476 Engenho Velho da Federação, Salvador Site 0476
Local Institution - 0477 Lucknow, Uttar Pradesh Site 0477
Local Institution - 0480 Hackensack, New Jersey Site 0480
Massachusetts General Hospital Boston, Massachusetts Albree Tower-Rader, Site 0479
Mayo Clinic - PPDS Rochester, Minnesota Jeffrey B. Geske, Site 0431
Mayo Clinic Arizona - PPDS Phoenix, Arizona Said Alsidawi, Site 0458
Medical University of South Carolina - PPDS Charleston, South Carolina Jessica Atkins, Site 0058
North Shore University Hospital-300 Community Dr Manhasset, New York Ronald Wharton, Site 0449
Oregon Health and Science University Portland, Oregon Ahmad Masri, Site0084
Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania Eric Popjes, Site 0047
Spectrum Health Grand Rapids, Michigan David Fermin, Site 0455
St. Luke's University Health Network Allentown, Pennsylvania Jamshid Shirani, Site 0020
Stanford University Palo Alto, California Matthew Wheeler, Site 0079
Stern Cardiovascular Foundation Inc Southaven, Mississippi Frank McGrew, Site 0207
Stony Brook Heart Institute Stony Brook, New York Michael Gavalas, Site 0007
UCSF School of Medicine San Francisco, California Theodore Abraham, Site 0406
University of Alabama at Birmingham: The Kirklin Clinic Birmingham, Alabama Jose Tallaj, Site 0082
University of California San Diego La Jolla, California Eric Adler, Site 0409
University of Florida Gainesville, Florida Mohammad Al-Ani, Site 0468
University of Iowa Hospitals and Clinics Iowa City, Iowa Ernesto Ruiz Duque, Site 0070
University of Kansas Medical Center Kansas City, Kansas Loren Berenbom, Site 0410
University of Michigan Comprehensive Cancer Center UMCCC-Gastrointestinal Cancer Clinic Ann Arbor, Michigan Sara Saberi, Site 0464
University of Nebraska Medical Center Omaha, Nebraska Douglas Stoller, Site 0435
University of Pennsylvania Philadelphia, Pennsylvania Anjali Owens, Site 0263
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Timothy Wang, Site 0081
University of Texam Houston Medical School Houston, Texas Ali Marian, Site0002
University of Texas Southwestern Medical Center Dallas, Texas James MacNamara, Site 0365
University of Utah - PPDS Salt Lake City, Utah Omar Wever-Pinzon, Site 0402
University of Virginia Health System Charlottesville, Virginia Christopher Kramer, Site 0478
University of Washington Medical Center Seattle, Washington David Owens, Site 0342
Usf Health South Tampa Center For Advanced Healthcare Tampa, Florida Thomas McDonald, Site 0281
Virginia Commonwealth University Medical Center Richmond, Virginia Mohammed Makkiya, Site 0095
Washington University School of Medicine St Louis, Missouri Richard Bach, Site 0461
Westchester Medical Center Valhalla, New York Srihari Naidu, Site 0426

Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury (NEUTRALIZE-AKI)

Mohamed Zidan, MD - mzidan@seastarmed.com

NA
NCT05758077
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Inclusion Criteria:
* Admitted to an ICU requiring CKRT:
• Must have AKI stage 2 or greater at the time of CKRT initiation.
• Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment. * At least 18 years of age but not older than 80 at the time of enrollment. * One additional life-threatening organ dysfunction present. * Acceptable vascular access for CKRT to include adequate lumen size and length of catheters. * Initial (non-binding) commitment to maintaining current level of care for at least 96 hours. * C-Reactive Protein \>3.5 mg/dl.
Exclusion Criteria:
* Not expected to survive next 24 hours. * Anticipated transition to comfort measures or hospice in next 4 days. * Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI. * Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation. * ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening. * Active COVID-19 infection with a primary admission diagnosis of COVID-19. * Chronic use of ventricular assist devices. * ESRD requiring chronic kidney replacement therapy. * History of CKD (greater than Stage 3). * AKI stage 0 or stage 1 at the time of CKRT initiation. * Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial. * Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization. * Active hemorrhage requiring blood transfusions at the time of screening. * Acute on Chronic Liver Failure. * Suspicion of hepato-renal syndrome. * Presence of any solid organ transplant at any time prior to admission. * Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury). * Bone marrow transplant within the last year. * Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission. * Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS. * Dry weight of \>150kg. * Platelet count \<15,000/mm3. * Patient is a prisoner or member of a vulnerable population. * Patient is pregnant or breast feeding. * Concurrent enrollment in another interventional clinical trial for an investigational drug or device. * Need for plasmapheresis.
DEVICE: Selective Cytopheretic Device, OTHER: Standard of Care
Acute Kidney Injury
continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis, acute tubular necrosis
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Show 29 locations

Study Locations

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Location Contacts
Brooke Army Medical Center Fort Sam Houston, Texas
Central Arkansas Veterans Healthcare Little Rock, Arkansas
Cleveland Clinic Cleveland, Ohio
Henry Ford Medical Center Detroit, Michigan
JMS Burn Center Augusta, Georgia
Mayo Clinic Rochester, Minnesota
Methodist Hospital San Antonio, Texas
Methodist Hospital Metropolitan San Antonio, Texas
Nazareth Hospital Philadelphia, Pennsylvania
Ochsner LSU Health Academic Medical Center Shreveport, Louisiana
Orlando Regional Medical Center Orlando, Florida
Ronald Reagan UCLA Medical Center Los Angeles, California
Saint Mary Medical Center Hobart, Indiana
Samaritan Health Corvallis, Oregon
Sentara Health Norfolk, Virginia
St Luke's University Hospital Bethlehem, Pennsylvania
Stanford University Palo Alto, California
UNLV Health Las Vegas, Nevada
United States Army Institute of Surgical Research JBSA Fort Sam Houston, Texas
University of Alabama Birmingham Hospital Birmingham, Alabama
University of Cincinnati Cincinnati, Ohio
University of Colorado Hospital Anschutz Medical Campus Aurora, Colorado
University of Iowa Hospital Iowa City, Iowa
University of Kentucky Healthcare Lexington, Kentucky
University of Michigan Ann Arbor, Michigan
University of Texas Health San Antonio San Antonio, Texas
University of Texas Southwestern Medical Center Dallas, Texas
Unversity of Rochester Rochester, New York
Virginia Commonwealth University Richmond, Virginia

Pediatric Obesity Weight Evaluation Registry (POWER) Study (POWER)

Shelley Kirk, PhD, RD, LD - Shelley.Kirk@cchmc.org

NCT02121132
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Inclusion Criteria:

• age 18 years or younger
• overweight or obese patient
• initial medical evaluation in a pediatric weight management program between March 1, 2014-April 30, 2020.
Exclusion Criteria:

• no exclusion criteria
Overweight, Obesity
Overweight, Obesity
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Study Locations

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Location Contacts
AdventHealth Orlando, Florida Mary Beth Vance - (mary.vance@adventhealth.com)
Advocate Children's Hospital Park Ridge, Illinois Susan Panek - (susan.panek@aah.org)
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois
Arkansas Children's Hospital Little Rock, Arkansas
Children's Healthcare of Atlanta Atlanta, Georgia
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital and Medical Center Omaha Omaha, Nebraska Leslie Turner - (lturner@childrensomaha.org)
Children's Hospital of San Antonio San Antonio, Texas
Children's Medical Center at UT Southwestern Dallas, Texas
Children's Mercy Hospital Kansas City, Missouri
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cleveland Clinic Cleveland, Ohio Roy Kim - (kimr@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas
Dell Children's Medical Center Austin, Texas
Duke Children's Hospital & Health Center Durham, North Carolina
Eastern Maine Medical Center Bangor, Maine
Fit Kids of Arizona at Northern Arizona Healthcare Cottonwood, Arizona Dirk de Heer - (dirk.deheer@nau.edu)
Helen DeVos Children's Hospital Grand Rapids, Michigan
Maine Medical Center - Barbara Bush Children's Hospital Portland, Maine
Marshfield Clinic Marshfield, Wisconsin
Mayo Clinic in Minnesota Rochester, Minnesota
OSF Saint Francis Medical Center Peoria, Illinois
Our Lady of The Lake Baton Rouge, Louisiana Micah Klumpp - (micah.klumpp@fmolhs.org)
Penn State Hershey Children's Hospital Hershey, Pennsylvania
Riley Children's Hospital - IU Health Indianapolis, Indiana Emily Ragozzino - (emragozz@iu.edu)
Seattle Children's Hospital Seattle, Washington
St. Luke's Children's Hospital Boise, Idaho
The Medical University of South Carolina Charleston, South Carolina Christine San Giovanni - (sangiova@musc.edu)
UCSF Benioff Children's Hospital Oakland Oakland, California
University of California Los Angeles Los Angeles, California Jennifer Yee - (jyee@lundquist.org)
University of Florida Health Science Center Jacksonville, Florida
University of Michigan C.S. Mott Children's Hospital Ann Arbor, Michigan
University of Minnesota Amplatz Children's Hospital Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of New Mexico Children's Hospital Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
VCU Health Richmond, Virginia Sarah Farthing - (sarah.malone@vcuhealth.org)

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN (SPRINKLE)

AstraZeneca Clinical Study Information Center - information.center@astrazeneca.com

Phase 1/Phase 2
NCT05309668
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Inclusion Criteria:

• Male and female participants aged ≥ 1 to < 7 years of age at the time their legally authorised representative (parent or guardian) signs the informed consent.
• All study participants must be diagnosed with NF1 with symptomatic inoperable PN as defined in protocol.
• Participants must have at least one measurable PN, defined as a PN of at least 3 cm measured in one dimension, which can be seen on at least 3 imaging slices and have a reasonably well-defined contour. Participants who have undergone surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable. The target PN will be defined as the clinically most relevant PN, which is symptomatic, inoperable and measurable by volumetric MRI analysis.
• Performance status: Participants must have a Lansky performance of ≥ 70 except in participants who are wheelchair bound or have limited mobility secondary to a need for mechanical breathing support (such as an airway PN requiring tracheostomy or continuous positive airway pressure) who must have a Lansky performance of ≥ 40.
• Participants must have a BSA ≥ 0.4 and ≤ 1.09 m2 at study entry (date of ICF signature).
• Mandatory provision of consent for the study signed and dated by a participant's legally authorised representative (parent or guardian) along with the paediatric assent form, if applicable.
Exclusion Criteria:

• Participants with confirmed or suspected malignant glioma or MPNST. Participants with low grade glioma (including optic glioma) not requiring systemic therapy are permitted.
• History of malignancy except for malignancy treatment with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk of recurrence.
• Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of selumetinib.
• A life-threatening illness, medical condition, organ system dysfunction or laboratory finding which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of selumetinib, or put the study outcomes at undue risk.
• Participants with clinically significant cardiovascular disease as defined in the protocol.
• Liver function tests: Bilirubin > 1.5 × the ULN for age with the exception of those with Gilbert syndrome (≥ 3 × ULN) or AST/ALT > 2 × ULN.
• Renal Function: Creatinine clearance or radioisotope glomerular filtration rate < 60 mL/min/1.73 m2 or Serum creatinine > 0.8 mg/dL (for participants aged ≥ 1 to < 4 years) or > 1.0 mg/dL (for participants aged ≥ 4 years).
• Participants with ophthalmological findings/condition as listed in the protocol.
• Have any unresolved chronic toxicity with CTCAE Grade ≥ 2 which are associated with previous therapy for NF1-PN (except hair changes such as alopecia or hair lightening)
• Participants who have previously been treated with a MEKi (including selumetinib) and have had disease progression, or due to toxicity have either discontinued treatment and/or required a dose reduction.
• Have inadequate haematological function defined as: An absolute neutrophil count < 1500/μL or Haemoglobin < 9g/dL or Platelets <100,000/μL or Have had a transfusion (of red cells or other blood derived products) within the 28 days prior to study entry (date of ICF signature).
• Have received or are receiving an IMP or other systemic NF1-PN target treatment (including MEKi) within 4 weeks prior to the first dose of study intervention, or within a period during which the IMP or systemic PN target treatment has not been cleared from the body (eg, a period of 5 'half-lives'), whichever is longer.
• Has received radiotherapy in the 6 weeks prior to start of study intervention or any prior radiotherapy directed at the target or non-target PN.
• Receiving herbal supplements or medications known to be strong or moderate inhibitors of the CYP3A4 and CYP2C19 enzymes or inducers of the CYP3A4 enzyme unless such products can be safely discontinued at least 14 days or 5 half-lives (whichever is longer) before the first dose of study medication.
• Inability to undergo MRI and/or contraindication for MRI examinations. Prosthesis or orthopaedic or dental braces that would interfere with volumetric analysis of target PN on MRI.
Drug: Selumetinib granule formulation, Drug: Selumetinib capsule formulation
Neurofibromatosis Type 1
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Show 20 locations

Study Locations

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Location Contacts
Children's Hospital of Philadelphia Philadelphia, Pennsylvania
Children's Hospital of Richmond at VCU Richmond, Virginia
Childrens Hospital Medical Center - Akron Akron, Ohio
Erasmus University Medical Center Rotterdam Rotterdam,
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Milano,
Hospital Sant Joan de Deu Barcelona,
Nagoya University Hospital Showa-Ku Nagoya,
National Center for Child Health and Development Setagaya-Ku, Tokyo
Oita University Hospital Oita, Yufu,
Ospedale Infantile Regina Margherita Torino,
Ospedale Pediatrico Bambino Gesu' di Roma Roma,
Phoenix Children's Hospital Phoenix, Arizona
Research Site Moscow,
Research Site Moscow,
Research Site Moscow,
Research Site Moscow,
Research Site Moscow,
Research Site Moscow,
Texas Children's Hospital Houston, Texas
University of Indiana (IU) Health - Riley Hospital for Children Indianapolis, Indiana

Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy (REMOTE-CIPN)

Noah A Kolb, MD - noah.kolb@uvmhealth.org

NA
NCT04763356
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Age ≥ 18.
• Completion of taxane, platinum, vinca alkaloid-based chemotherapy, bortezomib, thalidomide, lenalidomide, ixazomib, or brentuximab vedotin for cancer in the last 540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide or ixazomib for \> 90 days.
• Development of CIPN during or within 3 months of the most recently completed chemotherapy or previous neurotoxic chemotherapy for the same malignancy. For patients on ongoing maintenance therapy: Development of CIPN during current neurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomib brentuximab vendotin or vincristine. CIPN diagnosis will be based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy including the upper and lower extremities. The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as a combination of symptoms and signs of neuropathy including:
• At least 1 (one) of the following neuropathic symptoms: "asleep numbness", prickling or stabbing, burning or aching pain AND
• At least 1 (one) of the following: decreased distal sensation, or unequivocally decreased or absent ankle reflexes. (59) Clinical Diagnosis: a. Confirmation of CIPN diagnosis by CIPN expert (investigator/co-infestigator based on chart review +/- inperson/virtual interview with examination).
• Presence of at least one positive neuropathic sensory symptom on the NTSS-6 ranked as moderate or severe on the day of screening or in the preceding week based on recall.
• The ability to speak/ read sufficient English to be able to communicate with study NP over the phone, utilize the App, website and phone tree (all of which are only available in English).
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
• Expected treatment with another neurotoxic chemotherapy within the 13 week overall study duration (For example, platinum, taxane, vinca alkaloid, thalidomide, brentuximab vedotin or related drug, or arsenic trioxide. This exclusion does not apply to continuation of treatment for patients on maintenance therapy as described in the inclusion criteria).
• Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes).
• Currently receiving treatment at a pain clinic specifically for CIPN pain.
• Concurrent participation in a different CIPN or pain treatment trial.
• For women of childbearing potential: Current pregnancy
• For women of childbearing potential: Unwillingness to use and acceptable form of birth control for the duration of the study. Acceptable forms of birth control include long acting implantable contraception (ie IUDs, Nexplanon), Oral contraception pills, contraception injections, or strict abstinence if it is part of the subject's current lifestyle.
OTHER: Symptom Care at Home with NP follow up
Chemotherapy-induced Peripheral Neuropathy
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Study Locations

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Location Contacts
University of Utah Salt Lake City, Utah Samantha Stebleton - (samantha.stebleton@nurs.utah.edu) Christina Echeverria, MA - (christina.echeverria@nurs.utah.edu)
University of Vermont Burlington, Vermont Hannah Taylor, BA - (hannah.taylor@uvmhealth.org) Mary Healey, BA - (mary.healey@uvmhealth.org)
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia Melanie Crabtree - (crabtreemb@vcu.edu) Tyler Phillips - (phillipst5@vcu.edu)

Exploring the Familial Reach of Adolescent Obesity Treatment

Sarah M Farthing, MS - sarah.malone@vcuhealth.org

NCT05780970
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Inclusion Criteria:

• Untreated children: must be between 8-17 years of age and primarily living in the same household as the TEENS+ participants.
• Untreated caregiver: must be 18 years of age or older and primarily living in the same household as the TEENS+ participants.
• Treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver.
Exclusion Criteria:

• temporarily (<1yr) living in the home
• children with a BMI<5th%ile or caregivers with a BMI<18.5 kg/m2
• non-English speaking
• medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, Prader-Willi, G-tube placement, or malignancy
• clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa)
• following a medically-supervised/prescribed diet
• psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.
Other: No intervention
Pediatric Obesity
Pediatric Obesity, Lifestyle Intervention, Family-Level Change, Family-based Intervention
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Study Locations

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Location Contacts
Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, Ph.D. - (melanie.bean@vcuhealth.org)

Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial

ctrrecruit@vcu.edu

PHASE2
NCT05411081
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Inclusion Criteria:
* Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component * Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration) * Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling * Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS * Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage * Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment * Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease * Participants, if needed, must receive a stable dose of anti-convulsant therapy * Participants must not have cavitating pulmonary lesions * Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX \[registered trademark\]) are allowed * Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration * Participants must not have evidence of tumor invading or encasing any major blood vessels * Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery * Participants must not have had prior treatment with cabozantinib for any reason * Participants must not have had prior treatment or adjuvant therapy with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months * Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC * Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers * Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers * Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to =\< grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not clinically significant by the registering investigator * Participants must not be receiving or planning to receive any other investigational agents at time of registration * Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed. Other non-clinically significant autoimmune diseases are allowed if approved by the registering investigator * Participants must not be on steroid doses \> 10 mg prednisone equivalent. Replacement steroid doses for adrenal insufficiency will be allowed. Also, short duration steroid therapy to prevent allergic reactions are acceptable (e.g. prior to CT imaging) * Participants must be \>= 18 years of age * Participants must have a complete physical examination and medical history within 28 days prior to registration * Participants must have a Zubrod performance status of 0-2 * White blood count (WBC) \>= 2 x 10\^3/uL (within 28 days prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/uL (within 28 days prior to registration) * Platelet count \>= 100 x 10\^3/uL (within 28 days prior to registration) * Lymphocyte count \>= 0.5 x 10\^3/uL (within 28 days prior to registration) * Hemoglobin (\>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion * Total serum bilirubin =\< 1.5 x the institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration). Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN * Aspartate aminotransferase (AST) must be =\< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT) must be =\< 5 x the institutional ULN (within 28 days prior to registration) * Alanine aminotransferase (ALT), must be =\< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGPT) must be =\< 5 x the institutional ULN (within 28 days prior to registration) * Participants must have serum creatinine =\< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) \> 30 mL/min and obtained within 28 days prior to registration * Participants must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association \[NYHA\] class III \[moderate\] or class IV \[severe\]) at the time of registration * Participants must not have known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack \[TIA\] or other ischemic event) within 90 days prior to registration * Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days of registration, unless clinically stable with ongoing medical management * Participants must have urine protein \< 3+ within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24-hour collection must show less than 3 grams of protein * Participants must have documented blood pressure of systolic blood pressure (SBP) \< 150 mm Hg or diastolic blood pressure (DBP) \< 100 mm Hg within 14 days prior to registration * Participants with known human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy at registration and have undetectable viral load within 6 months of registration * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy within 6 months prior to registration, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load within 6 months prior to registration * Participants must be able to take oral medications (i.e., swallow pills whole). Participants must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease. Participants with intractable nausea or vomiting are not eligible * Participants must not have had any clinically-significant GI bleeding within 3 months prior to registration and participants must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula (e.g. Crohn's disease) * Participants must not have had hemoptysis of \>= (2.5 mL) of red blood, and do not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior registration * Participants 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 * Participants must not be pregnant or nursing, due to VEGF therapy being toxic to embryogenesis. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines * NOTE: For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations * As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
BIOLOGICAL: Atezolizumab, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging
Metastatic Papillary Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Banner MD Anderson Cancer Center Gilbert, Arizona
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan
Case Western Reserve University Cleveland, Ohio
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC - Englewood Dayton, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Duke Cancer Center Cary Cary, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke Cancer Center Raleigh Raleigh, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke University Medical Center Durham, North Carolina
East Jefferson General Hospital Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Farmington Health Center Farmington, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Hackensack University Medical Center Hackensack, New Jersey
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente - Panorama City Panorama City, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California
Kaiser Permanente South Bay Harbor City, California
Kaiser Permanente West Los Angeles Los Angeles, California
Kaiser Permanente-Anaheim Anaheim, California
Kaiser Permanente-Baldwin Park Baldwin Park, California
Kaiser Permanente-Bellflower Bellflower, California
Kaiser Permanente-Fontana Fontana, California
Kaiser Permanente-Irvine Irvine, California
Kaiser Permanente-Ontario Ontario, California
Kaiser Permanente-Riverside Riverside, California
Kaiser Permanente-San Diego Zion San Diego, California
Kaiser Permanente-San Marcos San Marcos, California
Kaiser Permanente-Woodland Hills Woodland Hills, California
Kettering Medical Center Kettering, Ohio
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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West Virginia University Charleston Division Charleston, West Virginia

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-US)

Judy Langer, MD, MS - langerj@nrgoncology.org

PHASE2
NCT05174169
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Inclusion Criteria:
The patient must have an ECOG performance status of 0 or 1. Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage III colon adenocarcinoma with R0 resection according to AJCC 8th edition criteria. No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis). The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible. The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, or Stage III colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera (after Step 1/Study entry and before Step2/Randomization). Patient must have sufficient tissue to meet protocol requirements. This blood specimen for the Signatera assay must be collected after surgery (and recommended at least 14 days post surgery). Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded. The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan). The interval between surgery (post-operative Day 7) and Step 1/Study entry must be no more than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7, but it cannot occur beyond 60 days from the actual date of the patient's surgery. Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling. Adequate hematologic function within 28 days before Step 1/Study entry defined as follows: * Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; * Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. * BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. * Platelet count must be greater than or equal to 100,000/mm3; and * Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before Step 1/Study entry defined as follows: * total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and * alkaline phosphatase must be less than 2.5 x ULN for the lab; and * AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before Step 1/Study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patients that have BMI greater than or equal to 28 (less than or equal to 30% above IBW). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Pregnancy test (urine or serum according to institutional standard) done within 14 days before Step 1/Study entry must be negative (for women of childbearing potential only). Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine. Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization Patient must have developed a ctDNA +ve assay during serial monitoring. Patient's willingness to be re-randomized affirmed. The patient must continue to have an ECOG performance status of 0 or 1. No radiographic evidence of overt metastatic disease. Pregnancy test (urine or serum according to institutional standard) done within 14 days before second randomization must be negative (for women of childbearing potential only). Adequate hematologic function within 28 days before second randomization defined as follows: * Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; * Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible. * BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups. * Platelet count must be greater than or equal to 100,000/mm3; and * Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before second randomization defined as follows: * total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and * alkaline phosphatase must be less than 2.5 x ULN for the lab; and * AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before second randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)
Exclusion Criteria:
Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.). Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected. Tumor-related bowel perforation. History of prior invasive colon malignancy, regardless of disease-free interval. History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary. Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians' discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but not required after consent. The optional cycle of chemotherapy should be started greater than or equal to 4 weeks from surgery and while awaiting Step 2 randomization. Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ. Synchronous primary rectal and/ or colon cancers. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0. Blood transfusion within two weeks before collection of blood for central ctDNA testing. Active seizure disorder uncontrolled by medication. Active or chronic infection requiring systemic therapy. Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency. Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1\*28 polymorphism. Pregnancy or lactation at the time of Step 1/Study entry. Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up). Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization Pregnancy or lactation at the time of randomization. No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.
DEVICE: Signatera test, DRUG: mFOLFOX6 3-6 month, DRUG: CAPOX 3 month, DRUG: mFOLFIRINOX, DRUG: mFOLFOX6 6 month, DRUG: CAPOX 6 month
Stage III Colon Cancer
ctDNA positive, ctDNA negative, Adjuvant Chemotherapy, Natera, Signatera, mFOLFOX6, Stage III, CAPOX, mFOLFIRINOX, Oxaliplatin, 5-Fluorouracil (5-FU), Capecitabine, Leucovorin, Irinotecan, Stage II
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Study Locations

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Location Contacts
AIS Cancer Center at San Joaquin Community Hospital Bakersfield, California
AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Addison Gilbert Hospital Gloucester, Massachusetts
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Littleton Littleton, Colorado
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois Site Public Contact - (ncorp@aah.org)
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Mercy Hospital Council Bluffs, Iowa
Allan Blair Cancer Centre Regina, Saskatchewan
Allegheny General Hospital Pittsburgh, Pennsylvania
Allegheny Valley Hospital Natrona Heights, Pennsylvania Site Public Contact - (Dawnmarie.DeFazio@ahn.org)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Altru Cancer Center Grand Forks, North Dakota
American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah Site Public Contact - (officeofresearch@imail.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Arnold Palmer Cancer Center Medical Oncology Norwin N. Huntingdon, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta Site Public Contact - (Roster@nrgoncology.org)
Ascension All Saints Hospital Racine, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital Chilton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Via Christi Hospitals Wichita Wichita, Kansas Site Public Contact - (research@viachristi.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
AtlantiCare Health Park-Cape May Court House Cape May Court House, New Jersey
AtlantiCare Surgery Center Egg Harbor, New Jersey
Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina
Atrium Health Union/LCI-Union Monroe, North Carolina
Atrium Health University City/LCI-University Charlotte, North Carolina
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Aultman Alliance Community Hospital Alliance, Ohio
Aultman Health Foundation Canton, Ohio Site Public Contact - (ClinicalReserachDept@aultman.com)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute - Mitchell Mitchell, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Pierre Pierre, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Yankton Yankton, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute-Aberdeen Aberdeen, South Dakota Site Public Contact - (oncregulatory@avera.org)
BASS Medical Group - Lennon Walnut Creek, California Site Public Contact - (brenna.lindsey@bassmedicalgroup.com)
BCCA-Cancer Centre for the North Prince George, British Columbia
BCCA-Vancouver Cancer Centre Vancouver, British Columbia
BCCA-Vancouver Island Cancer Centre Victoria, British Columbia
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Health Hamburg Lexington, Kentucky
Baptist Health Lexington Lexington, Kentucky
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Tumor Institute Oakland, California
Bayhealth Hospital Kent Campus Dover, Delaware
Bayhealth Hospital Sussex Campus Milford, Delaware
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Ben Taub General Hospital Houston, Texas
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Beverly Hospital Beverly, Massachusetts
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Blanchard Valley Hospital Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Boston Medical Center Boston, Massachusetts
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec Site Public Contact - (rechclinique@crchuq.ulaval.ca)
CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec
CSSS Champlain-Charles Le Moyne Greenfield Park, Quebec
CTCA at Southeastern Regional Medical Center Newnan, Georgia
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Cambridge Medical Center Cambridge, Minnesota
Cambridge Memorial Hospital Cambridge, Ontario
Camden Clark Medical Center Parkersburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Cancer Care Associates of York York, Pennsylvania
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (Roster@nrgoncology.org)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Kansas-Wichita Medical Arts Tower Wichita, Kansas Site Public Contact - (research@viachristi.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer Partners of Nebraska Lincoln, Nebraska Site Public Contact - (research@cancerpartners.com)
Cancer Specialists of Tidewater Limited Chesapeake, Virginia Site Public Contact - (casey.morris@rivhs.com)
Cancer Specialists of Tidewater-Suffolk Suffolk, Virginia Site Public Contact - (casey.morris@rivhs.com)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Caro Cancer Center Caro, Michigan
CaroMont Regional Medical Center Gastonia, North Carolina Site Public Contact - (tammy.cozad@caromonthealth.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Case Western Reserve University Cleveland, Ohio
Cedars Sinai Medical Center Los Angeles, California
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia Site Public Contact - (Kevin.Patel@centrahealth.com)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Chester County Hospital West Chester, Pennsylvania Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu)
City of Hope Antelope Valley Lancaster, California
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope South Bay Torrance, California
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Akron General Akron, Ohio Site Public Contact - (CancerAnswer@ccf.org)
Cleveland Clinic Cancer Center Independence Independence, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Mercy Hospital Canton, Ohio
Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic-Weston Weston, Florida
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Columbus Oncology and Hematology Associates Dublin, Ohio
Columbus Oncology and Hematology Associates Inc Columbus, Ohio
CommonSpirit Cancer Center Mercy Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (HemonCCTrials@geisinger.edu)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Cone Health Cancer Center Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana Farber-Merrimack Valley Methuen, Massachusetts
Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts
Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts
Dartmouth Cancer Center - North Saint Johnsbury, Vermont Site Public Contact - (cancer.research.nurse@hitchcock.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Physician LLC - Englewood Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC - Troy Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Miami Valley South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Wayne Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio
Dell Seton Medical Center at The University of Texas Austin, Texas
Denver Health Medical Center Denver, Colorado Site Public Contact - (ccrp@co-cancerresearch.org)
Dillon Health Center/Shaw Cancer Center Dillon, Colorado
Divine Providence Hospital Williamsport, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Doctors Hospital Columbus, Ohio
Drexel Town Square Health Center Oak Creek, Wisconsin
Dublin Methodist Hospital Dublin, Ohio
Duke Cancer Center Cary Cary, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke Cancer Center Raleigh Raleigh, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke University Medical Center Durham, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Eden Hospital Medical Center Castro Valley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Edward Hines Jr VA Hospital Hines, Illinois
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Eisenhower Army Medical Center Fort Eisenhower, Georgia
Eisenhower Medical Center Rancho Mirage, California
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Ephrata Cancer Center Ephrata, Pennsylvania
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Exeter Hospital Exeter, New Hampshire
FHCC Overlake Bellevue, Washington
FHCC at EvergreenHealth Kirkland, Washington
FHCC at Northwest Hospital Seattle, Washington
FMH James M Stockman Cancer Institute Frederick, Maryland
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Farmington Health Center Farmington, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Forbes Hospital Monroeville, Pennsylvania
Fox Chase Cancer Center Philadelphia, Pennsylvania
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Fred Hutchinson Cancer Center Seattle, Washington
Frederick Memorial Hospital Frederick, Maryland
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Fremont - Rideout Cancer Center Marysville, California
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Garnet Health Medical Center Middletown, New York Site Public Contact - (jgerlach@garnethealth.org)
Geauga Hospital Chardon, Ohio
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
George Washington University Medical Center Washington D.C., District of Columbia
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Grady Memorial Hospital Atlanta, Georgia
Grand View Hospital Sellersville, Pennsylvania
Grant Medical Center Columbus, Ohio
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Greater Baltimore Medical Center Baltimore, Maryland
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
Harold Alfond Center for Cancer Care Augusta, Maine
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Health Providence Novi Hospital Novi, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Health Providence Southfield Hospital Southfield, Michigan Site Public Contact - (kfife3@hfhs.org)
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford River District Hospital East China Township, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - GLCMS Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Highline Medical Center-Main Campus Burien, Washington
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hopital du Sacre-Coeur de Montreal Montreal, Quebec
Hotel-Dieu de Levis Lévis, Quebec
Humber River Hospital Toronto, Ontario Site Public Contact - (research@hrh.ca)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
IRMC Cancer Center Indiana, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Integris Cancer Institute of Oklahoma Oklahoma City, Oklahoma
Integris Southwest Medical Center Oklahoma City, Oklahoma Site Public Contact - (Roster@nrgoncology.org)
Intermountain Health Platte Valley Hospital Brighton, Colorado Site Public Contact - (peaksresearch@imail.org)
Intermountain Medical Center Murray, Utah Site Public Contact - (officeofresearch@imail.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Cherry Hill Hospital Cherry Hill, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Jefferson Hospital Jefferson Hills, Pennsylvania Site Public Contact - (ddefazio@wpahs.org)
Jefferson Methodist Hospital Philadelphia, Pennsylvania
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Jersey City Medical Center Jersey City, New Jersey Site Public Contact - (Roster@nrgoncology.org)
Jewish General Hospital Montreal, Quebec
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
John Muir Medical Center-Walnut Creek Walnut Creek, California Site Public Contact - (clinicalresearch@johnmuirhealth.com)
Jupiter Medical Center Jupiter, Florida
Juravinski Cancer Centre at Hamilton Health Sciences Hamilton, Ontario
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kaiser Permanente - Largo Medical Center Largo, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Lutherville - Timonium Medical Center Lutherville, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Medical Center-Vacaville Vacaville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente Northwest Portland, Oregon Site Public Contact - (information@kpchr.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Tysons Corner Medical Center McLean, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente- Marshall Medical Offices Redwood City, California
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Burke Medical Center Burke, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Capitol Hill Medical Center Washington D.C., District of Columbia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Caton Hill Medical Center Woodbridge, Virginia Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Deer Valley Medical Center Antioch, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Franklin Denver, Colorado
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Gaithersburg Medical Center Gaithersburg, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Lone Tree Lone Tree, Colorado
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Rock Creek Lafayette, Colorado
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Stockton Stockton, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Woodlawn Medical Center Baltimore, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Keck Medicine of USC Koreatown Los Angeles, California
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Kingston Health Sciences Centre Kingston, Ontario Site Public Contact - (cc-clinicaltrials@kgh.kari.net)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LDS Hospital Salt Lake City, Utah Site Public Contact - (officeofresearch@imail.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lahey Hospital and Medical Center Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Medical Center-Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lakeridge Health Oshawa Oshawa, Ontario
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania
Lancaster General Hospital Lancaster, Pennsylvania
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lenox Hill Hospital New York, New York
Levine Cancer Institute-Ballantyne Charlotte, North Carolina
Levine Cancer Institute-SouthPark Charlotte, North Carolina
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Logan Regional Hospital Logan, Utah Site Public Contact - (officeofresearch@imail.org)
Loma Linda University Medical Center Loma Linda, California
London Regional Cancer Program London, Ontario
Long Beach Memorial Medical Center-Todd Cancer Institute Long Beach, California
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Loyola University Medical Center Maywood, Illinois
Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado Site Public Contact - (peaksresearch@imail.org)
Lyndon Baines Johnson General Hospital Houston, Texas
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
MaineHealth Cancer Care Center of York County Sanford, Maine
MaineHealth Cancer Care and IV Therapy - Sanford Sanford, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Biddeford Biddeford, Maine
Manhattan Eye Ear and Throat Hospital New York, New York
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina Site Public Contact - (pardeecancerresearch@unchealth.unc.edu)
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marshall Cancer Center Cameron Park, California Site Public Contact - (cancerservices@marshallmedical.org)
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Wausau Center Wausau, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Neillsville Neillsville, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
McKay-Dee Hospital Center Ogden, Utah Site Public Contact - (officeofresearch@imail.org)
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland
MedStar Georgetown University Hospital Washington D.C., District of Columbia
MedStar Good Samaritan Hospital Baltimore, Maryland Site Public Contact - (Barbara.rector@medstar.net)
Medical Center of Baton Rouge Baton Rouge, Louisiana Site Public Contact - (Camille.Beck@Ochsner.org)
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Memorial Hospital West Pembroke Pines, Florida
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Modesto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Memorial Medical Center-Las Cruces Las Cruces, New Mexico Site Public Contact - (Deborah.Brown@LPNT.net)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center-West Lakes Clive, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Vincent Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health Sylvania Radiation Oncology Center Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Coon Rapids, Minnesota
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Medical Center Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Medical Center-West Lakes West Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
MetroHealth Medical Center Cleveland, Ohio Site Public Contact - (ababal@metrohealth.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Midlands Community Hospital Papillion, Nebraska
Mills Health Center San Mateo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Mills-Peninsula Medical Center Burlingame, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Mobile Infirmary Medical Center Mobile, Alabama
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monmouth Medical Center Southern Campus Lakewood, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Morristown Medical Center Morristown, New Jersey
Mount Carmel East Hospital Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Grove City Hospital Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Health Center West Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel New Albany Surgical Hospital New Albany, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital Medical Center Chicago, Illinois Site Public Contact - (suhi@sinai.org)
Mount Sinai South Nassau Valley Stream, New York Site Public Contact - (surgical.oncology@snch.org)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas Site Public Contact - (Emily.Carvell@bmhcc.org)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York
National Jewish Health-Western Hematology Oncology Golden, Colorado Site Public Contact - (glicht@co-cancerresearch.org)
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York Site Public Contact - (Adg9003@nyp.org)
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Newark Radiation Oncology Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Niagara Health System-Saint Catharines General St. Catharines, Ontario
North Coast Cancer Care Sandusky, Ohio Site Public Contact - (TaussigResearch@ccf.org)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
North York General Hospital Toronto, Ontario
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northern Westchester Hospital Mount Kisco, New York Site Public Contact - (AMellor@northwell.edu)
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northside Hospital - Duluth Duluth, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northside Hospital - Gwinnett Lawrenceville, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northwell Health Cancer Institute at Huntington Greenlawn, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Main Campus Crown Point, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Audubon Hospital and Medical Campus Louisville, Kentucky
Norton Brownsboro Hospital and Medical Campus Louisville, Kentucky Site Public Contact - (Roster@nrgoncology.org)
Norton Hospital Pavilion and Medical Campus Louisville, Kentucky Site Public Contact - (cancerresearch@nortonhealthcare.org)
OSF Saint Anthony's Health Center Alton, Illinois
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (WI_research_admin@hshs.org)
Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana Site Public Contact - (Cheryl.kesler@ochsner.org)
Ochsner High Grove Baton Rouge, Louisiana Site Public Contact - (Camielle.beck@ochsner.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio
OhioHealth Marion General Hospital Marion, Ohio
Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Orange Coast Memorial Medical Center Fountain Valley, California
Orion Cancer Care Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Orlando Health Cancer Institute Orlando, Florida Site Public Contact - (CancerClinicalTrials@orlandohealth.com)
Orlando Health Cancer Institute - Lake Mary Lake Mary, Florida Site Public Contact - (r-adultoncnewops@orlandohealth.com)
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Overlook Hospital Summit, New Jersey
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Pali Momi Medical Center ‘Aiea, Hawaii
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Camino Division Mountain View, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Gynecologic Oncology Mountain View, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Santa Cruz Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Pan American Center for Oncology Trials LLC San Juan, PR Site Public Contact - (ctsucontact@westat.com)
Pan American Center for Oncology Trials LLC - Cayey Cayey, Site Public Contact - (info@panoncologytrials.com)
Pan American Center for Oncology Trials LLC - Ciudadela San Juan, Site Public Contact - (info@panoncologytrials.com)
Pan American Center for Oncology Trials LLC - Dorado Dorado, Site Public Contact - (info@panoncologytrials.com)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
Parkview Regional Medical Center Fort Wayne, Indiana
Peninsula Cancer Institute-Cancer Specialists of Tidewater Virginia Beach, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Gloucester Gloucester, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Newport News Newport News, Virginia Site Public Contact - (casey.morris@rivhs.com)
Peninsula Cancer Institute-Williamsburg Williamsburg, Virginia Site Public Contact - (casey.morris@rivhs.com)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Pennsylvania Hospital Philadelphia, Pennsylvania Site Public Contact - (PennCancerTrials@careboxhealth.com)
Penrose-Saint Francis Healthcare Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Phelps Memorial Hospital Center Sleepy Hollow, New York
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
Piedmont Fayette Hospital Fayetteville, Georgia Site Public Contact - (Roster@nrgoncology.org)
Piedmont Henry Hospital Stockbridge, Georgia
Piedmont Hospital Atlanta, Georgia Site Public Contact - (ORS@piedmont.org)
Piedmont Newnan Hospital Newnan, Georgia Site Public Contact - (ors@piedmont.org)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
Presbyterian Kaseman Hospital Albuquerque, New Mexico Site Public Contact - (WBurman@phs.org)
Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico Site Public Contact - (WBurman@phs.org)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Medical Center Honolulu, Hawaii
Queens Cancer Center Rego Park, New York
Rapid City Regional Hospital Rapid City, South Dakota Site Public Contact - (research@monument.health)
Reading Hospital West Reading, Pennsylvania
Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rex Hematology Oncology Associates-Cary Cary, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
Rex Hematology Oncology Associates-Garner Garner, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridley-Tree Cancer Center Santa Barbara, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Riverside Methodist Hospital Columbus, Ohio
Riverton Hospital Riverton, Utah Site Public Contact - (officeofresearch@imail.org)
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rochester General Hospital Rochester, New York Site Public Contact - (tia.derosa@rochestergeneral.org)
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado Site Public Contact - (ResearchTracking@Centura.Org)
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Roger Williams Medical Center Providence, Rhode Island Site Public Contact - (fdallesandro@chartercare.org)
Royal Victoria Regional Health Centre Barrie, Ontario
Rush University Medical Center Chicago, Illinois Site Public Contact - (clinical_trials@rush.edu)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers New Jersey Medical School Newark, New Jersey
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
SMC Center for Hematology Oncology Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
SSM Health Good Samaritan Mount Vernon, Illinois Site Public Contact - (gayla.hall@ssmhealth.com)
STCC at DHR Health Institute for Research and Development Edinburg, Texas Site Public Contact - (dhrresearch@dhr-rgv.com)
Saddleback Memorial Medical Center Laguna Hills, California
Saint Agnes Hospital Baltimore, Maryland
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Ann's Hospital Westerville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Anthony Hospital Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
Saint Catherine Hospital Indianapolis, Indiana Site Public Contact - (Roster@nrgoncology.org)
Saint Clare Hospital Lakewood, Washington
Saint Elizabeth Boardman Hospital Boardman, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Elizabeth Hospital Enumclaw, Washington
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Francis Hospital Greenville, South Carolina
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint George Regional Medical Center St. George, Utah Site Public Contact - (officeofresearch@imail.org)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado
Saint Joseph Hospital - Orange Orange, California
Saint Joseph Hospital East Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph London London, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Regional Cancer Center Bryan, Texas
Saint Joseph Warren Hospital Warren, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Luke's East - Lee's Summit Lee's Summit, Missouri Site Public Contact - (aroland@kccop.org)
Saint Luke's Hospital of Kansas City Kansas City, Missouri Site Public Contact - (aroland@kccop.org)
Saint Luke's South Hospital Overland Park, Kansas Site Public Contact - (aroland@kccop.org)
Saint Mary Corwin Medical Center Pueblo, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado Site Public Contact - (ccrp@co-cancerresearch.org)
Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Michael Cancer Center Silverdale, Washington Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Michael's Hospital Toronto, Ontario
Saint Rita's Medical Center Lima, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Vincent Frontier Cancer Center Billings, Montana
Saint Vincent Hospital Erie, Pennsylvania
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Saints Mary and Elizabeth Hospital Louisville, Kentucky
Salinas Valley Memorial Salinas, California Site Public Contact - (tnielsen2@svmh.com)
Sandra L Maxwell Cancer Center Cedar City, Utah Site Public Contact - (officeofresearch@imail.org)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Cancer Center Worthington Worthington, Minnesota
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Thief River Falls Medical Center Thief River Falls, Minnesota
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Santa Cruz Radiation Oncology Medical Group Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Scott and White Memorial Hospital Temple, Texas
Sechler Family Cancer Center Lebanon, Pennsylvania Site Public Contact - (doxenberg@wellspan.org)
Shaw Cancer Center Edwards, Colorado
Sheboygan Physicians Group Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
Siouxland Regional Cancer Center Sioux City, Iowa
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Orange Care Center Orange, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Solinsky Center for Cancer Care Manchester, New Hampshire
South Jordan Health Center South Jordan, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
South Pointe Hospital Warrensville Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Southeastern Medical Oncology Center-Clinton Clinton, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Goldsboro Goldsboro, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southeastern Medical Oncology Center-Jacksonville Jacksonville, North Carolina Site Public Contact - (jfields@cancersmoc.com)
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ohio Medical Center Portsmouth, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
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Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

ctrrecruit@vcu.edu

PHASE2
NCT05111574
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Inclusion Criteria:
* STEP 0 INCLUSION CRITERIA * Histologically proven mucosal melanoma by local pathology * Central PD-L1 tumor tissue submission * STEP 1 INCLUSION CRITERIA * Receipt of the central PD-L1 testing results available * Report is required for randomization of resection R0 or R1 patients * Testing must be started in Step 0 but results can be reported after registration for resection R2 patients * Disease status-Resected R0 or R1 disease patients. Patients eligible for randomization have resected R0 or R1 disease (with negative margins or positive microscopic margins) that must meet one of the following 4 criteria as defined below: * Regional lymph node (LN) involvement; OR * In-transit metastases/satellite primary disease; OR * Single localized, primary disease meeting one of the following site-specific requirements: * Head/neck - Sinonasal (including nasopharynx): any primary lesion; Nasal or oral cavity; pT4a or above, given slightly improved OS * NOTE: Conjunctival: does not meet the qualification for eligibility * Anorectal - any primary lesion * Vaginal/cervical - any primary, as they have 5 year OS rates of 5-25% * Urinary tract - any primary urethral or bladder tumor * Penile * Vulvar- American Joint Committee on Cancer (AJCC) cutaneous stage IIB or higher * Esophageal/gallbladder - any primary * Locoregionally recurrent following prior resection, meeting at least one of the above criteria * In addition, patients must have undergone cross-sectional imaging of the brain, chest, abdomen and pelvis with no evidence of distant metastatic disease * Disease status-Non-resected R2 or metastatic disease patients * Non-resected R2 or metastatic disease that is assessable and measurable radiographically or by physical examination * Prior Treatment: * No prior systemic checkpoint inhibitor therapy of mucosal melanoma, including in the adjuvant setting, is allowed. Prior adjuvant chemotherapy or interferon is allowed. * No other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator. Exceptions may allow for adjuvant no evidence of disease (NED) cancers undergoing hormone based therapy may be eligible pending the other eligibility criteria are met and the principal investigator (PI) affirms the hormonal agent would not change the melanoma response. * Any radiation must have completed 28 days prior to randomization and the patient must have adequately recovered from its effects. * For resectable patients only: Surgery must have completed 28 days prior to randomization. * For resectable patients only: Surgery must have completed no more than 84 days prior to randomization. * Not pregnant and not nursing, because this study has an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Creatinine =\< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) \>= 50mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Albumin \>= 2.8 g/dL * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * No cardiovascular disease, including: * No history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry. * No history of current class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system. * No refractory hypertension defined as a blood pressure of systolic \> 140 mmHg and/or diastolic \> 90 mmHg despite adequate attempts at anti-hypertensive therapy. * No history of myocarditis. * No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months. * No corrected QT interval by Fridericia's formula (QTcF) \> 500 msec. Note: if initial QTcF is found to be \> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\< 500 ms, the subject meets eligibility in this regard. * No underlying hematologic issues, including: * Congenital bleeding diathesis * Gastrointestinal (GI) bleeding requiring intervention within the past 6 months, unless directly related to mucosal melanoma * Active hemoptysis within 42 days prior to study enrollment. * Active tumor lesions with cavitations or tumor lesions which invade, encase, or abut major blood vessels. The anatomic location and characteristics of primary tumors or metastases as well as the medical history should be carefully reviewed in the selection of subjects for treatment with cabozantinib/placebo. * Pulmonary emboli or deep vein thromboses (DVT) that require an active anticoagulation regimen. * No known or suspected history of cytopenia (low white blood cell \[WBC\], hemoglobin or platelet count) of greater than 3 months duration with an unknown cause, myelodysplastic syndrome, or hematologic malignancies. * No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of pre-registration (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics). * No known or suspected gastrointestinal disorder affecting absorption of oral medications. * Comorbid conditions: * No active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * No history of autoimmune motor neuropathy (e.g., Guillain-Barre syndrome, myasthenia gravis) or non-infectious pneumonitis. * No history of severe allergic reactions to an unknown allergen or any components of the study drugs or its excipients. * No history of gastrointestinal perforation or abdominal fistula. * No clinically suspected central nervous system (CNS) (leptomeningeal or parenchymal) metastases. Patients with a history of CNS metastasis(s) will be allowed as long as * The metastatic site(s) were adequately treated as demonstrated by clinical and radiographic improvement, AND * The patient has recovered from the intervention (no residual adverse events \> Common Terminology Criteria for Adverse Events \[CTCAE\] grade 1), AND * The patient has remained without occurrence of new or worsening CNS symptoms for a period of 28 days prior to enrollment. * No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma) within 2 years. * No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction. * No untreated spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression. Spinal metastases must have completed planned radiation or surgical therapy prior to registration. * Concomitant medications: * Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 5 days prior to the start of study treatment. * Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 5 days prior to the start of study treatment.
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, DRUG: Placebo Administration, PROCEDURE: Positron Emission Tomography
Anal Melanoma, Bladder Melanoma, Cervical Melanoma, Esophageal Melanoma, Gallbladder Melanoma, Head and Neck Mucosal Melanoma, Mucosal Melanoma, Nasopharyngeal Mucosal Melanoma, Oral Cavity Mucosal Melanoma, Penile Mucosal Melanoma, Rectal Melanoma, Recurrent Mucosal Melanoma, Sinonasal Mucosal Melanoma, Urethral Melanoma, Urinary System Mucosal Melanoma, Vaginal Melanoma, Vulvar Melanoma
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dayton Physician LLC - Englewood Dayton, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Jewish General Hospital Montreal, Quebec
Keck Medicine of USC Koreatown Los Angeles, California
Kettering Medical Center Kettering, Ohio
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Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
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Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Mills Health Center San Mateo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Palo Alto Medical Foundation Health Care Palo Alto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Palo Alto Medical Foundation-Fremont Fremont, California Site Public Contact - (clinicalresearch@sutterhealth.org)
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Palo Alto Medical Foundation-Sunnyvale Sunnyvale, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Premier Blood and Cancer Center Dayton, Ohio
Rapid City Regional Hospital Rapid City, South Dakota
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Southern Illinois University School of Medicine Springfield, Illinois
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Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
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UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
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VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases

ctrrecruit@vcu.edu

PHASE3
NCT05438212
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Inclusion Criteria:
* Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by magnetic resonance imaging (MRI) with contrast obtained within 14 days prior to registration * The maximum diameter of the lesion to be resected on the post-contrast MRI, as measured on any orthogonal plane (axial, sagittal, coronal), must measure \>= 2.0 cm and =\< 5.0 cm. * The maximum diameter of any lesions which will not be resected must be =\< 4.0 cm in maximum diameter * Known active or history of invasive non-central nervous system (CNS) primary cancer based on documented pathologic diagnosis within the past 3 years * All brain metastases must be located \>= 5 mm from the optic chiasm and outside the brainstem * Patient is able to medically tolerate surgery and SRS * Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon * History/physical examination within 14 days prior to registration * Age \>= 18 * Karnofsky performance status (KPS) \>= 60 within 14 days prior to registration * A negative urine or serum pregnancy test (in persons of childbearing potential) within =\< 14 days prior to registration. 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 * Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment on this study to prevent pregnancy * 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
Exclusion Criteria:
* Prior cranial radiotherapy, including whole brain radiotherapy, or SRS to the resection site * Note: The index lesion to be resected cannot have been previously treated with SRS (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol). Previous SRS to other lesions is allowed * Evidence of leptomeningeal disease (LMD) * Note: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion * Any medical conditions which would make this protocol unreasonably hazardous, including, but not limited to: contraindications to general endotracheal anesthesia; intracranial surgery; and stereotactic radiosurgery * Primary histology of germ cell tumor, small cell carcinoma or lymphoma * More than one brain metastasis planned for resection * Inability to undergo MRI with contrast * Planned administration of cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors within the 3 days prior to, the day of, or within 3 days after the completion of SRS * Note: chemotherapy and immunotherapy outside of this window are allowed
PROCEDURE: Brain Surgery, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Stereotactic Radiosurgery
Metastatic Malignant Neoplasm in the Brain
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Location Contacts
AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois Site Public Contact - (ncorp@aah.org)
Advocate South Suburban Hospital Hazel Crest, Illinois
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Regional Cancer Center Wausau, Wisconsin
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec Site Public Contact - (rechclinique@crchuq.ulaval.ca)
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec Site Public Contact - (info.cr.chum@ssss.gouv.qc.ca)
CJW Medical Center - Johnston-Willis Campus Richmond, Virginia
California Pacific Medical Center-Pacific Campus San Francisco, California
Cancer Care Center of O'Fallon O'Fallon, Illinois
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Capital Health Medical Center-Hopewell Pennington, New Jersey Site Public Contact - (clinicaltrials@capitalhealth.org)
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
CaroMont Regional Medical Center Gastonia, North Carolina Site Public Contact - (tammy.cozad@caromonthealth.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Castle Medical Center Kailua, Hawaii Site Public Contact - (Roster@nrgoncology.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Medical Center-Lakeside Lubbock, Texas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hospital/Cancer Center Naperville, Illinois
Elmhurst Memorial Hospital Elmhurst, Illinois
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Good Samaritan University Hospital West Islip, New York
Grady Health System Atlanta, Georgia
Grady Memorial Hospital Atlanta, Georgia Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Gunma University Hospital Gunma, Maebashi
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Henrico Doctor's Hospital Richmond, Virginia
Hokkaido University Hospital Sapporo, Hokkaido Site Public Contact - (hassi@med.hokudai.ac.jp)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jersey City Medical Center Jersey City, New Jersey Site Public Contact - (Roster@nrgoncology.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kyoto University Hospital Kyoto,
Lenox Hill Hospital New York, New York
Manhattan Eye Ear and Throat Hospital New York, New York
Mayo Clinic in Florida Jacksonville, Florida
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Medical Center Modesto, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Springfield Springfield, Missouri
Miami Cancer Institute Miami, Florida
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Sinai Chelsea New York, New York
Mount Sinai Hospital New York, New York
Mount Sinai West New York, New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
NYP/Weill Cornell Medical Center New York, New York
Nagoya University Hospital Showa-Ku Nagoya,
National Cancer Center Hospital Tokyo, Site Public Contact - (www-admin@ncc.go.jp)
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York Site Public Contact - (Adg9003@nyp.org)
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Northeast Radiation Oncology Center Dunmore, Pennsylvania
Northern Westchester Hospital Mount Kisco, New York Site Public Contact - (AMellor@northwell.edu)
Northwest Wisconsin Cancer Center Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Novant Health Cancer Institute Radiation Oncology - Wilmington Wilmington, North Carolina
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Pali Momi Medical Center ‘Aiea, Hawaii
Parkland Health Center - Farmington Farmington, Missouri
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Piedmont Hospital Atlanta, Georgia Site Public Contact - (ORS@piedmont.org)
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Medical Center Honolulu, Hawaii
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Roswell Park Cancer Institute Buffalo, New York
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SMC Center for Hematology Oncology Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Saint Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
Saint Joseph Hospital - Orange Orange, California
Saint Joseph's Hospital and Medical Center Phoenix, Arizona
Saint Luke's Hospital of Kansas City Kansas City, Missouri Site Public Contact - (aroland@kccop.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Southern Illinois University School of Medicine Springfield, Illinois
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Straub Clinic and Hospital Honolulu, Hawaii
Sutter Auburn Faith Hospital Auburn, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Pacific Medical Foundation Santa Rosa, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Roseville Medical Center Roseville, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Solano Medical Center/Cancer Center Vallejo, California Site Public Contact - (clinicalresearch@sutterhealth.org)
The Cancer Center of Hawaii-Liliha Honolulu, Hawaii
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The New York Hospital Medical Center of Queens Flushing, New York
The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii Site Public Contact - (rohta@queens.org)
The Research Institute of the McGill University Health Centre (MUHC) Montreal, Quebec Site Public Contact - (evelyn.ortega@muhc.mcgill.ca)
The Valley Hospital - Luckow Pavilion Paramus, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UCSF Medical Center-Parnassus San Francisco, California
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
UM Capital Region Medical Center Largo, Maryland Site Public Contact - (Sarah.Larson@umm.edu)
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UM Upper Chesapeake Medical Center Bel Air, Maryland
UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania
UPMC-Shadyside Hospital Pittsburgh, Pennsylvania
UW Cancer Center at ProHealth Care Waukesha, Wisconsin Site Public Contact - (Chanda.miller@phci.org)
University of Arizona Cancer Center-North Campus Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois
University of Hawaii Cancer Center Honolulu, Hawaii
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Health System Ridgewood Campus Ridgewood, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
Valley Health System-Hematology/Oncology Westwood, New Jersey
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Michael M. Dominello - (mdominel@med.wayne.edu)
Weisberg Cancer Treatment Center Farmington Hills, Michigan
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

ctrrecruit@vcu.edu

PHASE3
NCT04804644
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Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis); * Patients with de novo or recurrent small cell lung cancer are permitted. * Brain metastases =\< 4 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced magnetic resonance imaging (MRI) performed =\< 21 days prior to study entry. * The total tumor volume must be 30 cm\^3 or less. Lesion volume will be approximated by measuring the lesion's three perpendicular diameters on contrast enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g. xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumor volume. * Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer. * Brain metastases must be diagnosed on MRI, which will include the following elements: * REQUIRED MRI ELEMENTS * Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (Brain Volume Imaging) or 3D Fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm. * Pre-contrast T1 weighted imaging (3D imaging sequence strongly encouraged). * A minimum of one axial T2 FLAIR (preferred) or T2 sequence is required. This can be acquired as a two dimensional (2D) or 3D image. If 2D, the images should be obtained in the axial plane. * ADDITIONAL RECOMMENDATIONS * Recommendation is that an axial T2 FLAIR (preferred) sequence be performed instead of a T2 sequence. * Recommendation is that that pre-contrast 3D T1 be performed with the same parameters as the post-contrast 3D T1. * Recommendation is that imaging be performed on a 3 Tesla (3T) MRI. * Recommendation is that the study participants be scanned on the same MRI instrument at each time point. * Recommendation is that if additional sequences are obtained, these should meet the criteria outlined in Kaufmann et al., 2020. * If additional sequences are obtained, total imaging time should not exceed 60 minutes. * If additional metastases not known at the time of registration/randomization or seen in the MRI used for eligibility are subsequently found on the radiation therapy (RT) planning MRI such that the total intacranial volume exceeds 30 cm\^3, the patient is still considered eligible. * History/physical examination * Age \>= 18 * Karnofsky performance status of \>= 70 * Creatinine clearance \>= 30 ml/min * Following the diagnosis of brain metastases, patients can initiate and treat with systemic (chemotherapy and/or immunotherapy) before enrollment only if their brain metastases are asymptomatic and not located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex). However, within 21 days prior to enrollment, brain MRI must be repeated to confirm eligibility. * Patients with symptomatic brain metastases and/or brain metastases in eloquent locations (e.g., brainstem, pre-/post central gyrus, visual cortex) are eligible for enrollment on the trial; however, the specific treatment approach of starting with systemic therapy alone and delaying brain radiation is not recommended for these patients. * Concurrent immunotherapy with brain radiation (SRS or HA-WBRT) is permitted. * Negative urine or serum pregnancy test (in women of childbearing potential) within 14 days prior to registration. Women of childbearing potential and men who are sexually active must use contraception while on study. * Patients may have had prior intracranial surgical resection. * Because neurocognitive testing is the primary goal of this study, patients must be proficient in English or French Canadian. * The patient must provide study-specific informed consent prior to study entry. * Patients with impaired decision-making capacity are not permitted on study. * ELIGIBILITY CRITERIA PRIOR TO STEP 2 REGISTRATION * The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive test will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2. * NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration. * PRIOR TO STEP 2 REGISTRATION: The following baseline neurocognitive tests must be completed within 21 days prior to Step 2 registration: HVLT-R, TMT, and COWA. The neurocognitive tests will be uploaded into RAVE for evaluation by Dr. Wefel. Once the upload is complete, within 3 business days a notification will be sent via email to the RA to proceed to Step 2. NOTE: Completed baseline neurocognitive tests can be uploaded at the time of Step 1 registration.
Exclusion Criteria:
* Planned infusion of cytotoxic chemotherapy on the same day as SRS or HA-WBRT treatment. Patients may have had prior chemotherapy. Concurrent immunotherapy is permitted. * For patients receiving fractionated SRS on an every-other-day basis, planned infusion of cytotoxic chemotherapy is not permitted between SRS treatments. * Brainstem metastasis \> 10 cm\^3 * Prior allergic reaction to memantine. * Patients with definitive leptomeningeal metastases. * Known history of demyelinating disease such as multiple sclerosis. * Contraindication to MR imaging such as implanted metal devices that are MRI-incompatible, allergy to MRI contrast that cannot be adequately addressed with pre-contrast medications, or foreign bodies that preclude MRI imaging. (Questions regarding MRI compatibility of implanted objects should be reviewed with the Radiology Department performing the MRI). * Current use of (other N-methyl-D-aspartate \[NMDA\] antagonists) amantadine, ketamine, or dextromethorphan. * Radiographic evidence of hydrocephalus or other architectural change of the ventricular system resulting in significant anatomic distortion of the hippocampus, including placement of external ventricular drain or ventriculoperitoneal shunt. * Mild cases of hydrocephalus not resulting in significant anatomic distortion of the hippocampus are permitted. * Prior radiotherapy to the brain, including SRS, WBRT, or prophylactic cranial irradiation (PCI).
PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, DRUG: Memantine Hydrochloride, OTHER: Neurocognitive Assessment, RADIATION: Stereotactic Radiosurgery, OTHER: Survey Administration, RADIATION: Whole-Brain Radiotherapy
Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Lung Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
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Study Locations

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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Allan Blair Cancer Centre Regina, Saskatchewan
Allegheny General Hospital Pittsburgh, Pennsylvania
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Avera Cancer Institute Sioux Falls, South Dakota
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Health Lexington Lexington, Kentucky
Beebe Health Campus Rehoboth Beach, Delaware Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware Site Public Contact - (research@beebehealthcare.org)
Benefis Sletten Cancer Institute Great Falls, Montana
Billings Clinic Cancer Center Billings, Montana
Boston Medical Center Boston, Massachusetts
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec Site Public Contact - (rechclinique@crchuq.ulaval.ca)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Caro Cancer Center Caro, Michigan
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Central Maryland Radiation Oncology in Howard County Columbia, Maryland
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chambersburg Hospital Chambersburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Christiana Care Health System-Christiana Hospital Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware Site Public Contact - (lbarone@christianacare.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Cooper Hospital University Medical Center Camden, New Jersey
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Divine Providence Hospital Williamsport, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Drexel Town Square Health Center Oak Creek, Wisconsin
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Ephrata Cancer Center Ephrata, Pennsylvania
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina
Gibbs Cancer Center-Pelham Greer, South Carolina
Goshen Center for Cancer Care Goshen, Indiana Site Public Contact - (cccois@goshenhealth.com)
Grady Memorial Hospital Atlanta, Georgia Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Gundersen Lutheran Medical Center La Crosse, Wisconsin
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
IU Health Methodist Hospital Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
IU Health West Hospital Avon, Indiana Site Public Contact - (iutrials@iu.edu)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Jefferson Torresdale Hospital Philadelphia, Pennsylvania
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Logan Health Medical Center Kalispell, Montana
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
Luminis Health Anne Arundel Medical Center Annapolis, Maryland
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana Site Public Contact - (clinicalresearch@marybird.com)
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Hospital in Arizona Phoenix, Arizona
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McLaren Cancer Institute-Bay City Bay City, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Flint Flint, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Lapeer Region Lapeer, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Macomb Mount Clemens, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Northern Michigan Petoskey, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren-Port Huron Port Huron, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLeod Regional Medical Center Florence, South Carolina Site Public Contact - (dorie.sturgill@mcleodhealth.org)
MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore, Maryland
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital North Colorado Springs, Colorado
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Springfield Springfield, Missouri
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York
Montefiore Medical Center-Einstein Campus The Bronx, New York
Montefiore Medical Center-Weiler Hospital The Bronx, New York
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
Northern Westchester Hospital Mount Kisco, New York
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northside Hospital-Cherokee Canton, Georgia Site Public Contact - (clinical.trials@northside.com)
Northside Hospital-Forsyth Cumming, Georgia Site Public Contact - (clinicaltrials@northside.com)
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
OSF Saint Francis Medical Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Parkland Health Center - Farmington Farmington, Missouri
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Rush University Medical Center Chicago, Illinois
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
SMC Center for Hematology Oncology Union Union, South Carolina
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania
Saint Luke's Hospital - Monroe Campus Stroudsburg, Pennsylvania
Saint Luke's Hospital - Upper Bucks Campus Quakertown, Pennsylvania
Saint Luke's Hospital-Anderson Campus Easton, Pennsylvania
Saint Luke's Hospital-Quakertown Campus Quakertown, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania
Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Vincent Hospital Erie, Pennsylvania
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Sands Cancer Center Canandaigua, New York
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Sechler Family Cancer Center Lebanon, Pennsylvania Site Public Contact - (doxenberg@wellspan.org)
Self Regional Healthcare Greenwood, South Carolina Site Public Contact - (nmcgaha@selfregional.org)
Smilow Cancer Center/Yale-New Haven Hospital New Haven, Connecticut
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut
Spartanburg Medical Center Spartanburg, South Carolina
State University of New York Upstate Medical University Syracuse, New York
The Carle Foundation Hospital Urbana, Illinois Site Public Contact - (Research@carle.com)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
TidalHealth Peninsula Regional Salisbury, Maryland
TidalHealth Richard A Henson Cancer Institute Ocean Pines, Maryland
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UCHealth University of Colorado Hospital Aurora, Colorado
UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Upper Chesapeake Medical Center Bel Air, Maryland
UPMC Altoona Altoona, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
UPMC Cancer Center - Monroeville Monroeville, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania
UPMC Memorial York, Pennsylvania
UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania Site Public Contact - (klitchfield@PINNACLEHEALTH.org)
UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania
UPMC-Passavant Hospital Pittsburgh, Pennsylvania
UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania
UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania
UPMC-Saint Margaret Pittsburgh, Pennsylvania
UPMC-Shadyside Hospital Pittsburgh, Pennsylvania
USC / Norris Comprehensive Cancer Center Los Angeles, California
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Unity Hospital Fridley, Minnesota
University Health Network-Princess Margaret Hospital Toronto, Ontario
University of Chicago Comprehensive Cancer Center Chicago, Illinois
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Florida Health Science Center - Gainesville Gainesville, Florida
University of Maryland Shore Medical Center at Easton Easton, Maryland Site Public Contact - (Christina.weisenborn@umm.edu)
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York Site Public Contact - (BinghamE@upstate.edu)
Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York Site Public Contact - (BinghamE@upstate.edu)
Upstate Cancer Center at Verona Verona, New York
VCU Massey Comprehensive Cancer Center Richmond, Virginia
Wake Forest University Health Sciences Winston-Salem, North Carolina
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Weisberg Cancer Treatment Center Farmington Hills, Michigan Site Public Contact - (ctoadmin@karmanos.org)
WellSpan Health-York Cancer Center York, Pennsylvania
WellSpan Health-York Hospital York, Pennsylvania
Wilmot Cancer Institute Radiation Oncology at Greece Rochester, New York
Wilmot Cancer Institute at Webster Webster, New York
Yale University New Haven, Connecticut

A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma

ctrrecruit@vcu.edu

PHASE2
NCT05691478
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Inclusion Criteria:
* Patients must be \< 40 years of age at the time of enrollment. * Patients must have a body surface area of \>= 0.8 m\^2 at the time of enrollment. * Patients must have histologic diagnosis (by institutional pathologist) of newly diagnosed high grade osteosarcoma. Primary tumors of all extremity and axial sites are eligible as long as diagnosis of high-grade osteosarcoma is established. Osteosarcoma as a second malignancy is eligible if no prior exposure to systemic chemotherapies. * Feasibility Phase (NOTE: as of Amendment #2B, the feasibility phase has been completed) Patients must have metastatic disease and a resectable primary tumor. Designation of a primary tumor as resectable will be determined at the time of diagnosis by the institutional multidisciplinary team. For this study, metastatic disease is defined as one or more of the following: * Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases. * Lung metastases: defined as biopsy-proven metastasis or the presence of one or more pulmonary lesions \>= 5 mm, OR multiple pulmonary lesions \>= 3 mm or greater in size. * Bone metastases: Areas suspicious for bone metastasis based on fludeoxyglucose F-18 (18F-FDG)-positron emission tomography (PET) scan (or whole body technetium-99 bone scan if 18F-FDG-PET is unavailable at the treating institution) require confirmatory biopsy or supportive anatomic imaging of at least one suspicious site with either magnetic resonance imaging (MRI) or computed tomography (CT) (whole body 18F-FDG-PET/CT or 18F-FDG-PET/MR scans are acceptable). * Efficacy Phases (Phase 2/3) NOTE: as of Amendment #2B, the efficacy phase is open for enrollment. Patients with both localized and metastatic disease are eligible for the efficacy phase, regardless of resectability. Patients will be enrolled to two separate cohorts: * Cohort 1 (Standard Risk): Patients with non-pelvic primary osteosarcoma deemed to be resectable at the time of diagnosis by the institutional multidisciplinary team, without evidence of metastatic lesions. * Cohort 2 (High-Risk): Patients with a primary pelvic tumor, a primary tumor designated as unresectable by the institutional multidisciplinary team, AND/OR radiographic evidence of metastatic lesions. * A serum creatinine based on age/sex as follows (within 7 days prior to enrollment unless otherwise indicated): * (Age: Maximum Serum Creatinine \[mg/dL\]; Sex) * 1 month to \< 6 months: 0.4 (male); 0.4 (female) * 6 months to \< 1 year: 0.5 (male); 0.5 (female) * 1 to \< 2 years: 0.6 (male); 0.6 (female) * 2 to \< 6 years: 0.8 (male); 0.8 (female) * 6 to \< 10 years: 1 (male); 1 (female) * 10 to \< 13 years: 1.2 (male); 1.2 (female) * 13 to \< 16 years: 1.5 (male); 1.4 (female) * \>= 16 years: 1.7 (male); 1.4 (female) * OR - a 24 hour urine creatinine clearance \>= 70 mL/min/1.73 m\^2 * OR - a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment unless otherwise indicated) * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment unless otherwise indicated) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) Class III or IV congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias * Shortening fraction of \>= 27%, or * Ejection fraction of \>= 50% * Corrected QT interval by Fridericia (QTcF) \< 480 msec on electrocardiogram. Patients with Grade 1 prolonged QTc (450-480 msec) at time of study enrollment should have correctable causes of prolonged QTc addressed if possible (i.e., electrolytes, medications). * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment unless otherwise indicated) * Platelet count \>= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment) (within 7 days prior to enrollment unless otherwise indicated) * Hemoglobin \>= 8.0 g/dL (within 7 days prior to enrollment unless otherwise indicated) * International normalized ratio (INR) =\< 1.5 (within 7 days prior to enrollment unless otherwise indicated) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible as long as they are NOT receiving anti-retroviral agents that are strong inhibitors or inducers of CYP3A4, CYP2D6, and/or MRP2 transporter protein. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* Patients who have received previous systemic therapy for osteosarcoma or a prior oncologic diagnosis. * Patients who have central nervous system metastases. * Patients with central cavitating pulmonary lesions invading or encasing any major blood vessels in the lung. * Patients who are unable to swallow tablets. Tablets cannot be crushed or chewed. * Patients with gastrointestinal disorders including active disorders associated with a high risk of perforation or fistula formation. Specifically, no clinically significant gastrointestinal (GI) bleeding, GI perforation, bowel obstruction, intra-abdominal abscess or fistula for 6 months prior to enrollment, no hemoptysis or other signs of pulmonary hemorrhage for 3 months prior to enrollment. * Patients with active bleeding or bleeding diathesis. No clinically significant hematuria, hematemesis, or hemoptysis or other history of significant bleeding within 3 months prior to enrollment. * Patients with uncompensated or symptomatic hypothyroidism. Patients who have hypothyroidism controlled with thyroid replacement hormone are eligible. * Patients with moderate to severe hepatic impairment (Child-Pugh B or C). * Patients who have had primary tumor resection or attempted curative resection of metastases prior to enrollment. * Patients who have undergone other major surgical procedure (eg, laparotomy) within 14 days prior to enrollment. Thoracoscopic procedures for diagnostic purposes (biopsy of lung nodule) and central access such as port-a-cath placement are allowed. * Patients with a history of serious or non-healing wound or bone fracture (pathologic fracture of primary tumor is not considered exclusion). * Patients with any medical or surgical conditions that would interfere with gastrointestinal absorption of cabozantinib. * Patients with previously identify allergy or hypersensitivity to components of the study treatment formulations. * Patients who are receiving any other investigational agent not defined within this protocol are not eligible. * Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible. * Patients who received enzyme-inducing anticonvulsants within 14 days prior to enrollment. * Patients with a prior history of hypertension (\> 95th percentile for age, height, and sex for patients \< 18 years and \> 140/90 mmHg for patients \>= 18 years requiring medication for blood pressure control. * Patients who are receiving drugs that prolong QTc. * Patients receiving anticoagulation with oral coumarin agents (eg warfarin), direct thrombin inhibitors (eg dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines) and low dose, low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH and direct factor Xa inhibitors rivaroxaban or apixaban are allowed in subjects who are on a stable dose for at least 6 weeks before the first dose of study treatment, and who have had no complications from a thromboembolic event or the anticoagulation regimen. * Patients receiving strong CYP3A4 inducers or strong CYP3A4 inhibitors. * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Lactating females who plan to breastfeed their infants. * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of protocol therapy.
PROCEDURE: Bone Scan, DRUG: Cabozantinib S-malate, DRUG: Cisplatin, PROCEDURE: Computed Tomography, DRUG: Doxorubicin Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Methotrexate, PROCEDURE: Surgical Procedure, PROCEDURE: X-Ray Imaging
High Grade Osteosarcoma, Localized Osteosarcoma, Metastatic Osteosarcoma, Secondary Osteosarcoma
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Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec,
CancerCare Manitoba Winnipeg, Manitoba
Cardinal Glennon Children's Medical Center St Louis, Missouri
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (rryan@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Christchurch Hospital Christchurch,
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Children's Royal Oak, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Hackensack University Medical Center Hackensack, New Jersey
Hospital for Sick Children Toronto, Ontario
IWK Health Centre Halifax, Nova Scotia
Jim Pattison Children's Hospital Saskatoon, Saskatchewan
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Loma Linda University Medical Center Loma Linda, California
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mattel Children's Hospital UCLA Los Angeles, California
Medical City Dallas Hospital Dallas, Texas
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Miller Children's and Women's Hospital Long Beach Long Beach, California
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Starship Children's Hospital Grafton, Auckland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sydney Children's Hospital Randwick, New South Wales
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (cogbchoak@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UMC Cancer Center / UMC Health System Lubbock, Texas
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Florida Health Science Center - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan Site Public Contact - (slusserb@med.umich.edu)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Virginia University Charleston Division Charleston, West Virginia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Collection of Research Data and Samples From Patients Who Experience Immunotherapy Side Effects

David Kozono, MD, PhD - dkozono@bwh.harvard.edu

NCT04242095
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Inclusion Criteria:
* Received a regimen containing one or more immuno-oncology therapeutics * Must have experienced one or more of the following: * One or more serious (Grade 3-4) AEs that are likely immune-related * One or more Grade 2 dermatologic or rheumatologic AEs that are likely immune-related * Diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting IO treatment \*\* Note: Diagnosis of SARS-CoV-2 (COVID-19) is excluded * Hyperprogression. Image submission for patients experiencing hyperprogression is required. For assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review * Has not previously been registered to this study
PROCEDURE: Biospecimen Collection, OTHER: Medical Chart Review
Malignancy
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois Site Public Contact - (ncorp@aah.org)
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska
Alegent Health Immanuel Medical Center Omaha, Nebraska
Alegent Health Lakeside Hospital Omaha, Nebraska
Alegent Health Mercy Hospital Council Bluffs, Iowa
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska
Anchorage Radiation Therapy Center Anchorage, Alaska
Ann M Wierman MD LTD Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Ascension All Saints Hospital Racine, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital Chilton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin Site Public Contact - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Saint Francis Hospital Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee, Wisconsin Site Public Contact - (AWRI.Inquiry@Ascension.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Audie L Murphy VA Hospital San Antonio, Texas
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
BASS Medical Group - Lennon Walnut Creek, California Site Public Contact - (brenna.lindsey@bassmedicalgroup.com)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Bay Area Tumor Institute Oakland, California
Beebe Health Campus Rehoboth Beach, Delaware Site Public Contact - (research@beebehealthcare.org)
Beebe Medical Center Lewes, Delaware Site Public Contact - (research@beebehealthcare.org)
Beebe South Coastal Health Campus Millville, Delaware Site Public Contact - (research@beebehealthcare.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts
Bethesda North Hospital Cincinnati, Ohio
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming Site Public Contact - (research@billingsclinic.org)
Blanchard Valley Hospital Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Boulder Community Foothills Hospital Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Brigham and Women's Hospital Boston, Massachusetts
Broadlawns Medical Center Des Moines, Iowa
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska
CHI Health Saint Francis Grand Island, Nebraska
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Camden Clark Medical Center Parkersburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Cancer Care Associates of York York, Pennsylvania
Cancer Care Center of O'Fallon O'Fallon, Illinois
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Blood Specialists-Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Cancer and Blood Specialists-Shadow Las Vegas, Nevada
Cancer and Blood Specialists-Tenaya Las Vegas, Nevada
Carle BroMenn Medical Center Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois Site Public Contact - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan
CaroMont Regional Medical Center Gastonia, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Central Ohio Breast and Endocrine Surgery Gahanna, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Chambersburg Hospital Chambersburg, Pennsylvania Site Public Contact - (protocols@AllianceNCTN.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Christiana Care - Union Hospital Elkton, Maryland Site Public Contact - (frank.crum@christianacare.org)
Christiana Care Health System-Christiana Hospital Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania Site Public Contact - (lbarone@christianacare.org)
Christiana Care Health System-Wilmington Hospital Wilmington, Delaware Site Public Contact - (lbarone@christianacare.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Colorado Blood Cancer Institute Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Columbus Oncology and Hematology Associates Dublin, Ohio
Columbus Oncology and Hematology Associates Inc Columbus, Ohio
CommonSpirit Cancer Center Mercy Durango, Colorado
Commonwealth Cancer Center-Corbin Corbin, Kentucky
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dayton Physician LLC - Englewood Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC - Troy Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Miami Valley South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Wayne Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Clinical and Laboratory Physicians PA Newark, Delaware
Delaware Health Center-Grady Cancer Center Delaware, Ohio
Desert West Surgery Las Vegas, Nevada
Doctors Hospital Columbus, Ohio
Dublin Methodist Hospital Dublin, Ohio
Duke Cancer Center Cary Cary, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke Cancer Center Raleigh Raleigh, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, North Carolina
ECU Health Oncology Kenansville Kenansville, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina Site Public Contact - (research@ecuhealth.org)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Ephrata Cancer Center Ephrata, Pennsylvania
Ephrata Community Hospital Ephrata, Pennsylvania Site Public Contact - (protocols@AllianceNCTN.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Ridges Hospital Burnsville, Minnesota
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
First Dayton Cancer Care Kettering, Ohio
Flaget Memorial Hospital Bardstown, Kentucky
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Fred Hutchinson Cancer Center Seattle, Washington
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
GenesisCare USA - Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Las Vegas Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
GenesisCare USA - Vegas Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio
Grady Memorial Hospital Atlanta, Georgia
Grand Valley Oncology Grand Junction, Colorado Site Public Contact - (gvoclinicaltrials@gjhosp.org)
Grant Medical Center Columbus, Ohio
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo, Washington
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas, Nevada
HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas, Nevada
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-Auburn Auburn, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Henry Ford Health Providence Novi Hospital Novi, Michigan
Henry Ford Health Providence Southfield Hospital Southfield, Michigan
Henry Ford Health Saint John Hospital Detroit, Michigan Site Public Contact - (Kkeenan1@hfhs.org)
Henry Ford Health Warren Hospital Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Madison Heights Hospital - Breast Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford River District Hospital East China Township, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Rochester Hospital Rochester Hills, Michigan
Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Saint John Hospital - Van Elslander Grosse Pointe Woods, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Warren Hospital - GLCMS Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (protocols@AllianceNCTN.org)
Highline Medical Center-Main Campus Burien, Washington
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Care of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada Site Public Contact - (research@sncrf.org)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hope Cancer Clinic Livonia, Michigan
Hunterdon Medical Center Flemington, New Jersey
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Idaho Urologic Institute-Meridian Meridian, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Iowa Cancer Specialists Davenport, Iowa
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Healthcare Port Townsend, Washington
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Las Vegas Prostate Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pebble Henderson, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Pecos Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada Site Public Contact - (research@smcrf.org)
Las Vegas Urology - Sunset Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia
Lewistown Hospital Lewistown, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Longmont United Hospital Longmont, Colorado
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Lourdes Hospital Binghamton, New York
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Macomb Hematology Oncology PC Warren, Michigan
Margaret R Pardee Memorial Hospital Hendersonville, North Carolina Site Public Contact - (pardeecancerresearch@unchealth.unc.edu)
Marietta Memorial Hospital Marietta, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington, North Carolina Site Public Contact - (research@ecuhealth.org)
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin
Marshfield Clinic-Wausau Center Wausau, Wisconsin
Marshfield Medical Center - Ladysmith Ladysmith, Wisconsin
Marshfield Medical Center - Minocqua Minocqua, Wisconsin
Marshfield Medical Center - Weston Weston, Wisconsin
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin
Marshfield Medical Center-Marshfield Marshfield, Wisconsin
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin
Mary Greeley Medical Center Ames, Iowa
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
McFarland Clinic - Ames Ames, Iowa
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Memorial Hospital Marysville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Hospital of South Bend South Bend, Indiana
Mercy Cancer Center Merced, California
Mercy Cancer Center - Cape Girardeau Cape Girardeau, Missouri
Mercy Cancer Center - Carmichael Carmichael, California
Mercy Cancer Center - Elk Grove Elk Grove, California
Mercy Cancer Center - Rocklin Rocklin, California
Mercy Cancer Center - Sacramento Sacramento, California
Mercy Cancer Center-West Lakes Clive, Iowa
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Paducah Cancer Center Paducah, Kentucky Site Public Contact - (BJWarner@mercy.com)
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Vincent Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Hospital Washington Washington, Missouri
Mercy Infusion Center - Chippewa St Louis, Missouri
Mercy Medical Center Durango, Colorado
Mercy Medical Center Durango, Colorado
Mercy Medical Center - Des Moines Des Moines, Iowa
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California
MercyOne Genesis Davenport Cancer Center Davenport, Iowa
MercyOne Genesis Davenport Medical Center Davenport, Iowa
MercyOne Genesis Silvis Cancer Center Silvis, Illinois
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Methodist West Hospital West Des Moines, Iowa
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Midlands Community Hospital Papillion, Nebraska
Minneapolis VA Medical Center Minneapolis, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California
Mission Hope Medical Oncology - Santa Maria Santa Maria, California
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mount Carmel East Hospital Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Grove City Hospital Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Carmel Health Center West Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
MyMichigan Medical Center Alpena Alpena, Michigan Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Gladwin Gladwin, Michigan Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Gratiot Alma, Michigan Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Midland Midland, Michigan Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Mount Pleasant Mount Pleasant, Michigan Site Public Contact - (CVResearch@mymichigan.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Newark Radiation Oncology Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Newland Medical Associates-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
North Shore Medical Center Skokie, Illinois Site Public Contact - (ctsucontact@westat.com)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwest Medical Specialties PLLC Tacoma, Washington
OSF Saint Anthony Medical Center Rockford, Illinois
OSF Saint Anthony's Health Center Alton, Illinois
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio
OhioHealth Marion General Hospital Marion, Ohio
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at MountainView Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Orion Cancer Care Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Our Lady of the Lake Medical Oncology Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California
Pacific Gynecology Specialists Seattle, Washington
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington
PeaceHealth Southwest Medical Center Vancouver, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (rcrompton@peacehealth.org)
Penrose-Saint Francis Healthcare Colorado Springs, Colorado
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Portland VA Medical Center Portland, Oregon
Pottstown Hospital Pottstown, Pennsylvania
Premier Blood and Cancer Center Dayton, Ohio
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Princeton Community Hospital Princeton, West Virginia
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon
Providence Hood River Memorial Hospital Hood River, Oregon Site Public Contact - (canrsrchstudies@provdience.org)
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Regional Cancer Partnership Everett, Washington Site Public Contact - (marilyn.birchman@providence.org)
Providence Regional Cancer System-Aberdeen Aberdeen, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Centralia Centralia, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Lacey Lacey, Washington Site Public Contact - (deidre.dillon@providence.org)
Providence Regional Cancer System-Shelton Shelton, Washington
Providence Regional Cancer System-Yelm Yelm, Washington
Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank, California Site Public Contact - (Najee.Boucher@providence.org)
Providence Saint Mary Regional Cancer Center Walla Walla, Washington Site Public Contact - (Cheryl.Dodd@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Veterans Administration Hospital Providence, Rhode Island
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Radiation Oncology Associates Reno, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Redeemer Health Meadowbrook, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverside Methodist Hospital Columbus, Ohio
Rocky Mountain Cancer Centers - Centennial Centennial, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers - Swedish Englewood, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Aurora Aurora, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Boulder Boulder, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Littleton Littleton, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado Site Public Contact - (ResearchTracking@Centura.Org)
Rocky Mountain Cancer Centers-Midtown Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado
Rocky Mountain Cancer Centers-Rose Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado Site Public Contact - (info@westernstatesncorp.org)
Rocky Mountain Cancer Centers-Thornton Thornton, Colorado Site Public Contact - (info@westernstatesncorp.org)
Roger Williams Medical Center Providence, Rhode Island Site Public Contact - (fdallesandro@chartercare.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
SSM Health Good Samaritan Mount Vernon, Illinois Site Public Contact - (gayla.hall@ssmhealth.com)
SUNY Upstate Medical Center-Community Campus Syracuse, New York
Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Ann's Hospital Westerville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Saint Anthony Hospital Lakewood, Colorado
Saint Anthony North Hospital Westminster, Colorado
Saint Charles Health System Bend, Oregon Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Charles Health System-Redmond Redmond, Oregon
Saint Clare Hospital Lakewood, Washington
Saint Elizabeth Boardman Hospital Boardman, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Elizabeth Hospital Enumclaw, Washington
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Francis Cancer Center Greenville, South Carolina
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Greenville, South Carolina
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Helena Hospital St. Helena, California
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital Lexington, Kentucky
Saint Joseph Hospital East Lexington, Kentucky
Saint Joseph London London, Kentucky
Saint Joseph Mount Sterling Mount Sterling, Kentucky
Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky
Saint Joseph Regional Cancer Center Bryan, Texas
Saint Joseph Warren Hospital Warren, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Saint Joseph's Medical Center Stockton, California
Saint Joseph's/Candler - Bluffton Campus Bluffton, South Carolina
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary Corwin Medical Center Pueblo, Colorado
Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Michael Cancer Center Silverdale, Washington
Saint Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.org)
Saint Peter's Community Hospital Helena, Montana
Saint Rita's Medical Center Lima, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Saints Mary and Elizabeth Hospital Louisville, Kentucky
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Cancer Center Worthington Worthington, Minnesota
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Medical Center Fargo Fargo, North Dakota
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford South University Medical Center Fargo, North Dakota
Sanford Thief River Falls Medical Center Thief River Falls, Minnesota
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Sechler Family Cancer Center Lebanon, Pennsylvania Site Public Contact - (doxenberg@wellspan.org)
Singing River Hospital Pascagoula, Mississippi
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Skagit Regional Health Cancer Care Center Mount Vernon, Washington Site Public Contact - (rcccclinicalresearch@skagitvalleyhospital.org)
South Carolina Cancer Specialists PC Hilton Head Island, South Carolina
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ohio Medical Center Portsmouth, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Southpointe-Sanford Medical Center Fargo Fargo, North Dakota
Southwest Illinois Health Services LLP Swansea, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Springfield Regional Cancer Center Springfield, Ohio
Springfield Regional Medical Center Springfield, Ohio
State University of New York Upstate Medical University Syracuse, New York
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Cancer Institute-Issaquah Issaquah, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Covenant Hospital Chicago, Illinois
Swedish Medical Center-Ballard Campus Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-Cherry Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
Swedish Medical Center-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The Carle Foundation Hospital Urbana, Illinois Site Public Contact - (Research@carle.com)
The Don and Sybil Harrington Cancer Center Amarillo, Texas Site Public Contact - (Gina.Cravey@bsahs.org)
The Mark H Zangmeister Center Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
The Melanoma and Skin Cancer Institute Englewood, Colorado Site Public Contact - (ryan.weight@theskincancerinstitute.com)
The Women's Imaging Center Denver, Colorado Site Public Contact - (info@westernstatesncorp.org)
TidalHealth Nanticoke / Allen Cancer Center Seaford, Delaware
TriHealth Cancer Institute-Anderson Cincinnati, Ohio
TriHealth Cancer Institute-Westside Cincinnati, Ohio
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Medical Center - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
UM Saint Joseph Medical Center Towson, Maryland Site Public Contact - (Jeanmarie.downing@umm.edu)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
United Hospital Center Bridgeport, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Unity Hospital Fridley, Minnesota
University Cancer Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University Medical Center of Southern Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio
University of Cincinnati Cancer Center-West Chester West Chester, Ohio
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico
University of Washington Medical Center - Montlake Seattle, Washington
UofL Health Medical Center Northeast Louisville, Kentucky
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Upstate Cancer Center at Oswego Oswego, New York Site Public Contact - (McDowelE@upstate.edu)
Upstate Cancer Center at Verona Verona, New York Site Public Contact - (McDowelE@upstate.edu)
Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Green Valley Henderson, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Northwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Urology Specialists of Nevada - Southwest Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Valley Radiation Oncology Peru, Illinois
Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut
Veterans Affairs Loma Linda Healthcare System Loma Linda, California
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin Site Public Contact - (ncorp@aurora.org)
WVUH-Berkely Medical Center Martinsburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Walter Knox Memorial Hospital Emmett, Idaho
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne Hospital Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Welch Cancer Center Sheridan, Wyoming
WellSpan Health-York Cancer Center York, Pennsylvania
WellSpan Health-York Hospital York, Pennsylvania
WellSpan Medical Oncology and Hematology Chambersburg, Pennsylvania
WellSpan Medical Oncology and Hematology Chambersburg, Pennsylvania
West Jefferson Medical Center Marrero, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
West Suburban Medical Center River Forest, Illinois
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Western Illinois Cancer Treatment Center Galesburg, Illinois
Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia
Woodland Memorial Hospital Woodland, California
Zuckerberg San Francisco General Hospital San Francisco, California Site Public Contact - (Paul.Couey@ucsf.edu)

Neuroscience-informed Treatment to Remotely Target Reward Mechanisms in Post-acute Anorexia Nervosa

Kira Venables - venableskg@vcu.edu

NA
NCT05799872
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Inclusion Criteria:

• Age \> or = 18 years old
• Ability to read and speak in English
• DSM-5 diagnosis of AN or atypical AN at admission to higher-level care
• In higher-level care discharging to outpatient care or discharged to outpatient care within the past 3 months
• Current BMI \> or = 18.5 kg/m2 (or will be by time of discharge)
• BMI increase of \> or = 0.5 kg/m2 while in higher-level care
• Ability to designate and sign a release of information for a primary physical or mental health provider for study duration
• Willingness to participate in weekly assessments (e.g., weight monitoring) and audio or video recording of study therapy sessions for study duration
• Access to a smartphone and/or computer permitting engagement in remote therapy and assessment.
Exclusion Criteria:

• Medical instability for outpatient care;
• Pregnancy
• Lifetime DSM-5 primary psychotic or bipolar-I disorder
• Current DSM-5 substance use disorder
• Enrollment in outpatient therapy with highly overlapping content to PAT-AN
BEHAVIORAL: Positive Affect Treatment for Anorexia Nervosa (PAT-AN):, BEHAVIORAL: Psychoeducational and Behavioral Therapy (PBT)
Anorexia Nervosa
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Virginia Commonwealth University Richmond, Virginia

Comprehensive Tobacco Cessation for Cancer Patients and Survivors

Antonice Wall - walla2@vcu.edu

NA
NCT05805722
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Inclusion Criteria:
* Provision of signed and dated informed consent form * Stated willingness to comply with study procedures and availability for the duration of the study * Have a documented history of cancer of any type, whether active or in remission * Identify as a current or recently-quit tobacco user
Exclusion Criteria:
* Not a VCUHealth patient * Non English-speaking
BEHAVIORAL: Behavioral counseling for tobacco cessation
Tobacco Use Cessation, Cancer
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Virginia Commonwealth University Richmond, Virginia Massey CPC Team - (masseycpc@vcu.edu)

Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS)

Fran L Balamuth, MD PhD MSCE - BalamuthF@chop.edu

PHASE3
NCT04102371
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Inclusion Criteria:

• Males or females age \>2 months to \<18 years
• Clinician concern for septic shock, operationalized as:
• a "positive" ED sepsis alert confirmed by a physician OR
• physician decision to treat for septic shock OR
• a physician diagnosis of septic shock requiring parenteral antibiotics and fluid resuscitation
• Administration of at least one IV/Intraosseous (IO) fluid bolus for resuscitation and additional fluid deemed likely to be necessary to treat poor perfusion, or clinician judgment that \>1 fluid bolus is highly likely to be required. Poor perfusion is defined as physician's judgement of hypotension or abnormal (either "flash" or "prolonged") capillary refill.
• Receipt of ≤40 mL/kg IV/IO total crystalloid fluid prior to randomization
• Parental/guardian permission (informed consent) if time permits; otherwise, Exception from informed consent (EFIC) criteria met
Exclusion Criteria:

• Treating physician judges that patient's condition deems it unsafe to administer either NS or BF (since patients will be equally likely to receive NS or BF at time of study enrollment), including:
• Clinical suspicion for impending brain herniation
• Known hyperkalemia, defined as non-hemolyzed whole blood or plasma/serum potassium \> 6 mEq/L, based on data available at or before patient meets criteria for study enrollment
• Known hypercalcemia, defined as plasma/serum total calcium \>12 mg/dL or whole blood ionized calcium \>1.35 mmol/L, based on data available at or before patient meets criteria for study enrollment
• Known acute fulminant hepatic failure, defined as plasma/serum alanine aminotransferase (ALT) \>10,000 U/L or total bilirubin \>12.0 mg/dL, based on data available at or before patient meets criteria for study enrollment
• Known history of severe hepatic impairment, defined as cirrhosis, "liver failure", or awaiting transplant
• Known history of severe renal impairment, defined as peritoneal dialysis or hemodialysis
• Known metabolic/mitochondrial disorder, inborn error of metabolism, or primary mineralocorticoid deficiency as reported by participant, legally authorized representative (LAR) or accompanying caregiver, or as listed in the medical record
• Other concern for which the treating clinician deems it unsafe to administer either NS or LR
• Known pregnancy determined by routine history disclosed by patient and/or accompanying acquaintance.
• Known prisoner
• Known allergy to a crystalloid fluid
• Indication of declined consent to participate based on presence of an opt-out bracelet with appropriate messaging embossed into the bracelet, the presence of the patient's name on an opt-out list that will be kept up-to-date and checked prior to randomization, or verbal "opt-out" prior to enrollment.
DRUG: Lactated Ringer, DRUG: Normal Saline, DRUG: Plasma-lyte
Shock, Septic
Sepsis, Septic Shock, Fluid resuscitation, Saline, Balanced Fluid, Mortality, Crystalloid, PlasmaLyte, Lactated Ringer's, Kidney injury
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Boston Children's Hospital Boston, Massachusetts Matt Eisenberg, MD - (Matthew.Eisenberg@childrens.harvard.edu)
CHLA: Children's Hospital Los Angeles Los Angeles, California Ara Festekjian, MD - (afestekjian@chla.usc.edu)
CS Mott Children's Hospital Ann Arbor, Michigan Alex Rogers, MD - (alexroge@umich.edu) Allison Cator, MD - (acator@med.umich.edu)
Children's Colorado: University of Colorado Denver, Colorado Lilliam Ambroggio, PhD - (lilliam.ambroggio@cuanschutz.edu)
Children's Hospital of Atlanta Atlanta, Georgia Claudia Morris, MD - (Claudia.r.morris@emory.edu)
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Bob Hickey, MD - (robert.hickey@chp.edu)
Children's Hospital of Richmond at VCU Richmond, Virginia Nikki Miller Ferguson, MD - (nikki.millerferguson@vcuhealth.org)
Children's National Medical Center Washington D.C., District of Columbia Ioannis Koutroulis, MD - (IKOUTROULI@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Michelle Eckerle, MD - (Michelle.Eckerle@cchmc.org)
Columbia: New York-Presbyterian Hospital New York, New York Maria Kwok, MD - (myk2102@cumc.columbia.edu)
Dallas Children's: Children's Medical Center Dallas/UT southwestern Dallas, Texas Mohamed Badawy, MD - (Mohamed.Badawy@UTSouthwestern.edu)
Hasbro Children's Hospital Providence, Rhode Island Susan Duffy, MD - (SDuffy@Lifespan.org)
Lurie Children's: Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Elizabeth Alpern, MD - (EAlpern@luriechildrens.org)
Milwaukee (MCW): Medical College of Wisconsin Milwaukee, Wisconsin Shannon Baumer-Mouradian, MD - (sbaumer@mcw.edu)
NYU Langone New York, New York
Nationwide Children's Hospital Columbus, Ohio Julia Lloyd, MD - (Julia.Lloyd@nationwidechildrens.org)
Primary Children's: University of Utah Salt Lake City, Utah Roni Lane, MD - (roni.lane@hsc.utah.edu)
Seattle Children's Hospital Seattle, Washington Neil Uspal, MD - (neil.uspal@seattlechildrens.org)
Texas Children's Hospital Houston, Texas Julie McManemy, MD - (jkmcmane@texaschildrens.org)
The Children's Hospital of Philadelphia Philadelphia, Pennsylvania Fran Balamuth, MD PhD MSCE - (balamuthf@chop.edu) Scott Weiss, MD MSCE - (scott.weiss@nemours.org)
UC Davis: University of California, Davis Davis, California Cheryl Vance, MD - (cpvance@ucdavis.edu) Nathan Kupperman, MD - (nkuppermann@ucdavis.edu)
UCSF Benioff Children's Hospital San Francisco, California Karim Mansour, MD - (Karim.Mansour@ucsf.edu)
Universtity of Texas MD Anderson Houston, Texas
Washington University St Louis, Missouri Lindsay Clukies, MD - (lindsayedavidson@wustl.edu)

Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

Phase 1
NCT05206357
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Inclusion Criteria:

• Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
• Disease pathologically confirmed (tumor tissue) by local testing.
• Relapsed or primary refractory disease meeting any of the following criteria:
• Progressive disease at any time during second-line chemoimmunotherapy (CIT).
• Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
• Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
• Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
• Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
• Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
• Recovery from toxic effects of prior chemoimmunotherapy.
• Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
• Adequate bone marrow, hepatic, and renal function.
Exclusion Criteria:

• Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
• Other malignancy requiring therapy.
• Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.
Drug: Epcoritamab
Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma, ABBV-GMAB-3013, Epcoritamab, Burkitt's or Burkitt-like Lymphoma/Leukemia, Diffuse Large B-cell Lymphoma, Aggressive Mature (CD20+) B-cell Lymphoma, Cancer, Relapsed/Refractory Aggressive Mature B-cell Neoplasms
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Azienda Ospedaliero Universitaria Meyer /ID# 240049 Florence, Firenze
CHU Bordeaux - Hopital Pellegrin /ID# 240832 Bordeaux,
CHU Sainte-Justine /ID# 240766 Montreal, Quebec
CHU de Nantes, Hotel Dieu -HME /ID# 240831 Nantes, Pays-de-la-Loire
Children's Hospital at Westmead /ID# 240091 Westmead,
Children's Hospital of Philadelphia - Main /ID# 239294 Philadelphia, Pennsylvania
Children's Hospital of Richmond at VCU /ID# 242770 Richmond, Virginia
Cincinnati Childrens Hospital Medical Center /ID# 239823 Cincinnati, Ohio
Dokuz Eylul University Medical Faculty /ID# 239954 Izmir,
Fakultni Nemocnice Brno /ID# 239956 Brno,
Fakultni Nemocnice v Motole /ID# 239957 Praha,
Fondazione IRCCS San Gerardo dei Tintori /ID# 245592 Monza, Monza E Brianza
Hospices Civils de Lyon /ID# 240834 Lyon,
Hospital Infantil Universitario Nino Jesus /ID# 240717 Madrid,
Hospital Universitario Vall d'Hebron /ID# 240715 Barcelona,
Hospital for Sick Children /ID# 240767 Toronto, Ontario
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 240039 Rome, Lazio
Institut Gustave Roussy /ID# 240966 Villejuif Cedex, Val-de-Marne
Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 240026 Istanbul,
Kyoto University Hospital /ID# 246907 Kyoto-shi, Kyoto
Levine Children's Hospital /ID# 242765 Charlotte, North Carolina
Lucile Packard Children's Hospitals - Stanford /ID# 240854 Palo Alto, California
NHO Nagoya Medical Center /ID# 246680 Nagoya-shi, Aichi
National Cancer Center Hospital /ID# 246722 Chuo-ku, Tokyo
National Center for Child Health and Development /ID# 246658 Setagaya-ku, Tokyo
National Taiwan University Hospital /ID# 242890 Taipei City,
New York Medical College /ID# 239208 Valhalla, New York
Nicklaus Children's Hospital /ID# 241174 Miami, Florida
Osaka City General Hospital /ID# 246906 Osaka-shi, Osaka
Perth Children's Hospital /ID# 240382 Nedlands, Western Australia
Prinses Maxima Centrum /ID# 239815 Utrecht,
Rambam Health Care Campus /ID# 240037 Haifa,
Royal Children's Hospital /ID# 240384 Parkville, Victoria
Samsung Medical Center /ID# 239895 Seoul,
Schneider Children's Medical Center /ID# 240171 Petah Tikva,
Seoul National University Hospital /ID# 239894 Seoul,
St Jude Children's Research Hospital /ID# 239184 Memphis, Tennessee
The Chaim Sheba Medical Center /ID# 240670 Ramat Gan, Tel-Aviv
Universitaetsklinikum Erlangen /ID# 240861 Erlangen, Bayern
Universitaetsklinikum Giessen und Marburg /ID# 240787 Marburg,
Universitaetsklinikum Muenster /ID# 239970 Muenster, Nordrhein-Westfalen
Universitaetsmedizin Rostock /ID# 240891 Rostock,
Universitair Ziekenhuis Leuven /ID# 242384 Leuven, Vlaams-Brabant
University of Texas Southwestern Medical Center /ID# 240892 Dallas, Texas

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1) (cAMeLot-1)

Study Contact - Participate-In-This-Study1@its.jnj.com

PHASE1
NCT04811560
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Inclusion Criteria:
Phase 1: * Age 2 years and above (pediatric cohort only), all other cohorts 18 years and above * Relapsed or refractory (R/R) acute leukemia and has exhausted, or is ineligible for, available therapeutic options * Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations Phase: 2 * Participants greater than 18 years are eligible * Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed/refractory disease * AML harboring KMT2A-r (gene rearrangement/translocation) or NPM1 mutations only For Both Phase 1 and 2: * Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count less than or equal to (\<=) 20\*10\^9/liter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate greater than equal (\>=) 30 milliliter per minute (mL/min) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \>40 mL/min per the CKiD (Chronic Kidney Disease in Children) Schwartz formula * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \>=70 by Lansky scale (for participants less than \[\<\]16 years of age) or \>=70 Karnofsky scale (for participants \>=16 years of age) * A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment * Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment
Exclusion Criteria:
* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria * Active central nervous system (CNS) disease * Prior solid organ transplantation * QTc according to Fridericia's formula (QTcF) for males \>= 450 millisecond (msec) or for females \>= 470 msec. Participants with a family history of Long QT syndrome are excluded * Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \<=3 months before the first dose of study treatment; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \<=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \<=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement) * Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)
DRUG: Bleximenib
Acute Leukemias, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
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Asan Medical Center Seoul,
Baylor University Medical Center Dallas, Texas
CHRU Nancy Brabois Vandoeuvre les Nancy,
CHU Bretonneau Tours cedex,
CHU Lyon Sud Pierre Benite,
CHU de Nantes hotel Dieu Nantes,
Carmel Medical Center Haifa, Haifa District
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie Pessac,
China Medical University Hospital Taichung,
City of Hope Duarte, California
Clinica Univ. de Navarra Pamplona,
Dana Farber Cancer Institute Boston, Massachusetts
First Affiliated Hospital Medical School of Zhejiang University Hang Zhou,
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fukushima Medical University Hospital Fukushima,
Gold Coast University Hospital Southport,
Gunmaken Saiseikai Maebashi Hospital Maebashi,
Gustave Roussy Villejuif,
Guys and St Thomas NHS Foundation Trust London,
Hadassah University Hospita Ein Kerem Jerusalem,
Henan Cancer Hospital Zhengzhou, Henan
Hokkaido University Hospital Sapporo, Hokkaido
Hopital Jean Minjoz Besançon,
Hopital Maisonneuve Rosemont Montreal, Quebec
Hopital Saint Louis Paris,
Hopital trousseau- APHP Paris,
Hosp Clinic de Barcelona Barcelona,
Hosp Clinico Univ de Salamanca Salamanca,
Hosp Univ Fund Jimenez Diaz Madrid,
Hosp Univ Vall D Hebron Barcelona,
Hosp. Clinico Univ. de Valencia Valencia,
Hosp. Gral. Univ. Gregorio Marañon Madrid,
Hosp. Virgen Del Rocio Seville,
Houston Methodist Hospital Houston, Texas
Institut Paoli Calmettes Marseille,
Institut Universitaire du Cancer Toulouse Oncopole Toulouse,
Institut de Cancerologie Strasbourg Europe ICANS Strasbourg,
Institute of Hematology and Blood Diseases Hospital Tianjin,
Instituto D Or de Pesquisa e Ensino Salvador,
Instituto D Or de Pesquisa e Ensino IDOR São Paulo,
Kanazawa University Hospital Kanazawa,
Karmanos Cancer Institute Detroit, Michigan
Kobe City Medical Center General Hospital Kobe,
Kyushu University Hospital Fukuoka,
Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
MD Anderson Houston, Texas
Maine Health Providence, Rhode Island
Massachusetts General Hospital Boston, Massachusetts
Medical College of WI at Froedtert Milwaukee, Wisconsin
Ministerio da Saude Instituto Nacional do Cancer Rio de Janeiro,
Monash Medical Centre Clayton, Victoria
Montefiore Medical Center The Bronx, New York
NTT Medical Center Tokyo Tokyo,
NYU Langone Medical Center New York, New York
Nagoya University Hospital Showa-Ku Nagoya,
Nanfang Hospital of Southern Medical Hospital Guangzhou,
National Cancer Center Hospital East Kashiwa-shi, Chiba
National Cheng Kung University Hospital Tainan City,
National Taiwan University Hospital Taipei,
Norton Cancer Institute Louisville, Kentucky
Oregon Health and Science University Portland, Oregon
Oxford University Hospitals NHS Trust Oxfordshire,
Peking University First Hospital Beijing,
Princess Margaret Cancer Centre University Health Network Toronto, Ontario
Qilu Hospital of Shandong University Jinan, Shandong
Roswell Park Comprehensive Cancer Center Buffalo, New York
Royal Perth Hospital Perth, Western Australia
START Midwest Grand Rapids, Michigan
Samsung Medical Center Seoul,
San Antonio Methodist TX Transplant Physicians Group San Antonio, Texas
Seoul National University Hospital Seoul,
Sheba Medical Center Ramat Gan,
St Francis Hospital & Health Centers Indiana Blood and Marrow Transplantation Indianapolis, Indiana
Swedish Cancer Institute Seattle, Washington
Tel Aviv Sourasky Medical Center Tel Aviv,
The Christie NHS Foundation Trust Manchester,
The Clatterbridge Cancer Centre Liverpool,
The First Affiliated Hospital of NanChang University Nanchang, Jiangxi
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang
Union Hospital Tongji Medical College of Huazhong University of Science and Technology Wuhan,
University College London Hospitals London,
University Hospital of Wales Cardiff,
University Hospitals Plymouth NHS Trust Plymouth,
University of California Irvine Medical Center Orange, California
University of California San Francisco San Francisco, California
University of California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Fukui Hospital Yoshida-gun, Fukui
University of New Mexico Albuquerque, New Mexico
University of Tennessee Medical Center Knoxville, Tennessee
Vancouver Coastal Health Vancouver, British Columbia
Virginia Commonwealth University Richmond, Virginia
West China Hospital Si Chuan University Chengdu,
Yamagata University Hospital Yamagata, Yamagata
Zhongda Hospital Southeast University Nanjing, Jiangsu
the First Hospital of Jilin University Changchun,

Enhancing Oral Cancer Awareness Among Minorities

Tamas Gal, Ph.D - Tamas.Gal@vcuhealth.org

NA
NCT06682494
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Inclusion Criteria:
* Identify as African American as defined by the US Census * Participants must be able to read, speak, and write in English
Exclusion Criteria:
* Individuals who cannot physically or mentally participate in the research project will be excluded * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners
BEHAVIORAL: Traditional Education, BEHAVIORAL: AI-powered Chatbox
Oral Cancer, Chatbot, Patient Education, Prevention, Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Oropharyngeal Cancers
AI-powered Chatbox, Oral cancer prevention, Socio-economic barriers
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Virginia Commonwealth University Richmond, Virginia Tamas Gal, Ph.D - (Tamas.Gal@vcuhealth.org)

A Study to Test Whether BI 1356225 Improves Impulsive Behavior in Men With Opioid Use Disorder Who Are Taking Buprenorphine

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

PHASE1
NCT06628622
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Inclusion Criteria:

• Male participants, 18 to 65 years of age, both inclusively, at the time of consent
• Meet current diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria for opioid use disorder, of at least moderate severity within the 12 months prior to screening
• Currently engaged in medications for opioid use disorder (MOUD) treatment with one of the following regimens:
• buprenorphine/naloxone sublingual film total daily dose ranging from 8 mg/2 mg to 24 mg/6 mg for at least 2 weeks at screening OR
• buprenorphine/naloxone sublingual tablet from 5.7 mg/1.4 mg to 17.1 mg/4.3 mg total daily dose for at least 2 weeks at screening OR
• buprenorphine sublingual tablet from 8 mg to 24 mg total daily dose for at least 2 weeks at screening OR
• on a stable dose of depot injectable buprenorphine for at least 5 weeks at screening, with at least 1 week since last depot buprenorphine injection
• Have a current MOUD prescription in accordance with inclusion criterion 4 and a positive urine drug screen for buprenorphine during screening and upon presenting for randomization to document buprenorphine use
• Willingness to abstain from using alcohol for 24 hours (h) and all other drugs of abuse for 72 h prior to Day 1 and through discharge from the trial site on Day 9
• Further inclusion criteria apply
Exclusion Criteria:

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, or autism spectrum disorder as confirmed by the mini international neuropsychiatric interview (MINI) at the screening visit
• Moderate or severe substance use disorder other than opioid use disorder (OUD) within the 6 months prior to screening (excluding tobacco, caffeine, and moderate stimulant use)
• Severe stimulant use disorder within the 6 months prior to screening
• Any other psychiatric disorder that is not currently stable in symptoms and treatment. Stable is defined as having no significant changes in symptom acuity or treatment (medication or psychotherapy treatment) in the 8 weeks prior to randomization
• Score of ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
• Positive results on a urine drug screen for ≥3 drugs (not counting buprenorphine or TCAs) at screening. In the case of a positive drug screen for 1 or 2 agents, if the participant does not meet the exclusion criteria regarding substance use disorder for these compounds, they may be included if the investigator determines that use will not be an impediment to trial participation or accurate data collection
• Any positive result on a urine drug screen (not counting buprenorphine, TCAs, or cannabis) at admission to the trial site on Day -1
• Intoxication at screening or randomization, as determined by clinical exam and breathalyzer
• Further exclusion criteria apply
DRUG: BI 1356225, DRUG: Placebo
Opioid Use Disorder
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Collaborative Neuroscience Research, LLC, Los Alamitos Los Alamitos, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ERG Clinical Research - Houston Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hassman Research Institute-Marlton-66897 Marlton, New Jersey Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of California Los Angeles Los Angeles, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Virginia Commonwealth University Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
iResearch Atlanta Decatur, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003)

Toll Free Number - Trialsites@msd.com

PHASE3
NCT06136624
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Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology. * Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening * Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI). * Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA) * Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment * Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM) * Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment * Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment * Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment * If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment * Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization * Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening. * Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria:
* Has a gastrointestinal disorder that might affect absorption * Has a history of pituitary dysfunction * Has poorly controlled diabetes mellitus * Has clinically significant abnormal serum potassium or sodium level * Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events * Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization * Has a history of clinically significant ventricular arrhythmias * Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization * Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications * Participants who have not adequately recovered from major surgery or have ongoing surgical complications * Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization * Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization * Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization * Has received colony-stimulating factors within 28 days before the date of randomization * Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization * Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks * Has a "superscan" bone scan * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has an active infection requiring systemic therapy * Has concurrent active HBV or known active HCV infection * Has a history of long QTc syndrome * Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy) * Is unable to swallow capsules/tablets * Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures * Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention * Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\]) * Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention
DRUG: Opevesostat, DRUG: Abiraterone acetate, DRUG: Enzalutamide, DRUG: Hydrocortisone, DRUG: Fludrocortisone acetate, DRUG: Prednisone, DRUG: Dexamethasone
Prostate Cancer Metastatic
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Study Locations

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A. C. Camargo Cancer Center ( Site 0310) São Paulo, São Paulo
AHN Allegheny General Hospital ( Site 0001) Pittsburgh, Pennsylvania
Ad-Vance Medical Research-Research ( Site 1353) Ponce,
Addenbrooke's Hospital ( Site 1605) Cambridge, Cambridgeshire
Affiliated hospital of Jiangnan university ( Site 0434) Wuxi, Jiangsu
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477) Uppsala, Uppsala County
Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227) Lørenskog, Akershus
Akita University Hospital ( Site 0904) Akita,
Aliada-Oncologìa ( Site 1257) Lima,
Amsterdam UMC, locatie VUmc ( Site 1156) Amsterdam, North Holland
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552) Ankara,
Anschutz Cancer Pavilion ( Site 0046) Aurora, Colorado
Asahikawa Medical University Hospital ( Site 0901) Asahikawa, Hokkaido
Asan Medical Center-Oncology ( Site 1402) Songpagu, Seoul
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Buenos Aires, Buenos Aires F.D.
Atlantic Health System Morristown Medical Center ( Site 0115) Morristown, New Jersey
Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota
Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota
Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752) Kecskemét, Bács-Kiskun county
Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554) Adana,
Beijing Cancer hospital-Urinary Surgery ( Site 0395) Beijing, Beijing Municipality
Beijing Friendship Hospital Affiliate of Capital University ( Site 0396) Beijing, Beijing Municipality
Bell Land General Hospital ( Site 0913) Sakai, Osaka
Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia
Bradford Hill Norte ( Site 0357) Antofagasta,
Bradfordhill-Clinical Area ( Site 0351) Santiago, Region M. de Santiago
Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) Miami, Florida
CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103) Guadalajara, Jalisco
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632) Rennes, Ille-et-Vilaine
Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630) Nîmes, Gard
Centre Hospitalier de l'Université de Montréal ( Site 0326) Montreal, Quebec
Centre Hospitalier de la Côte Basque ( Site 0633) Bayonne, Pyrenees-Atlantiques
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328) Greenfield Park, Quebec
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629) Clermont-Ferrand, Puy-de-Dome
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327) Québec, Quebec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329) Sherbrooke, Quebec
Centro de Investigacion Clinica de Oaxaca ( Site 1109) Oaxaca City,
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302) Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504) Taoyuan District,
Charing Cross Hospital-Oncology Research ( Site 1606) London, Hammersmith and Fulham
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679) Berlin,
China Medical University Hospital-Department of Urology ( Site 1503) Taichung,
Chongqing Three Gorges Central Hospital's ( Site 0426) Chongqing, Chongqing Municipality
Chongqing University Cancer Hospital ( Site 0416) Chongqing, Chongqing Municipality
Chulalongkorn University ( Site 1530) Bangkok, Bangkok
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501) Bogotá, Bogota D.C.
Clinica Universidad Catolica del Maule-Oncology ( Site 0355) Talca, Maule Region
Clinical Research Chile SpA ( Site 0358) Valdivia, Los Ríos Region
Clínica Imbanaco S.A.S ( Site 0509) Santiago de Cali, Valle del Cauca Department
Clínica Sánchez Ferrer ( Site 1261) Trujillo, La Libertad
Clínica de Neoplasias Litoral ( Site 0305) Itajaí, Santa Catarina
Colorado Clinical Research ( Site 0067) Lakewood, Colorado
Complexo Hospitalario Universitario de Ourense ( Site 1426) Ourense, Orense
Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada
Cross Cancer Institute ( Site 0332) Edmonton, Alberta
Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758) Debrecen,
Dubbo Hospital ( Site 0235) Dubbo, New South Wales
Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203) Dunedin, Otago
ETZ Elisabeth-Internal Medicine ( Site 1160) Tilburg, North Brabant
Ehime University Hospital ( Site 0918) Tōon, Ehime
Emek Medical Center ( Site 0830) Afula,
FALP ( Site 0353) Santiago, Region M. de Santiago
Faculty of Medicine - Khon Kaen University ( Site 1526) Muang, Changwat Khon Kaen
Faculty of Medicine Siriraj Hospital ( Site 1531) Bangkok, Bangkok
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555) Olomouc, Olomoucký kraj
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554) Ostrava, Moravskoslezský kraj
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551) Prague, Praha 5
Filios Alta Medicina ( Site 1106) Monterrey, Nuevo León
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436) Huaian, Jiangsu
Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877) Milan, Lombardy
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151) Schiedam, South Holland
Fred Hutchinson Cancer Center ( Site 0013) Seattle, Washington
Fudan University Shanghai Cancer Center-Urology department ( Site 0376) Shanghai, Shanghai Municipality
Fukushima Medical University Hospital ( Site 0933) Fukushima,
Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204) Mendoza,
Fundación Cardiovascular de Colombia ( Site 0503) Piedecuesta, Santander Department
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430) Valencia, Valenciana, Comunitat
Fundación Valle del Lili ( Site 0505) Santiago de Cali, Valle del Cauca Department
Gifu University Hospital ( Site 0910) Gifu,
Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland
Gulhane Egitim Arastirma Hastanesi ( Site 1558) Ankara,
Gustave Roussy ( Site 0626) Villejuif, Val-de-Marne
HELIOS Kliniken Schwerin ( Site 0694) Schwerin, Mecklenburg-Vorpommern
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428) Seville,
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551) Ankara,
Hadassah Medical Center ( Site 0833) Jerusalem,
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164) The Hague, South Holland
Henry Ford Hospital ( Site 0015) Detroit, Michigan
Hiroshima University Hospital ( Site 0916) Hiroshima,
Hokkaido University Hospital ( Site 0931) Sapporo, Hokkaido
Hospital Aleman-Oncology ( Site 0207) Buenos Aires,
Hospital Británico de Buenos Aires-Oncology ( Site 0202) Ciudad Autónoma de Buenos Aires, Buenos Aires
Hospital Felicio Rocho ( Site 0317) Belo Horizonte, Minas Gerais
Hospital Jerez de la Frontera ( Site 1427) Jerez de la Frontera, Cadiz
Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078) Kuala Lumpur,
Hospital Lucus Augusti-Oncology ( Site 1432) Lugo,
Hospital Mario Penna ( Site 0309) Belo Horizonte, Minas Gerais
Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320) Vitória, Espírito Santo
Hospital Sultan Ismail ( Site 1081) Johor Bahru, Johor
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433) Madrid, Madrid, Comunidad de
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431) Madrid, Madrid, Comunidad de
Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314) Curitiba, Paraná
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308) Bragança Paulista, São Paulo
Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921) Kitakyushu, Fukuoka
Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388) Shanghai, Shanghai Municipality
Hubei Cancer Hospital-Urinary surgery ( Site 0406) Wuhan, Hubei
Hunan Cancer Hospital ( Site 0405) Changsha, Hunan
Hôpital Européen Georges Pompidou ( Site 0628) Paris,
IC La Serena Research ( Site 0356) La Serena, Coquimbo Region
IMAT S.A.S ( Site 0504) Montería, Departamento de Córdoba
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256) Lima,
IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254) Lima,
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879) Meldola, Emilia-Romagna
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627) Strasbourg, Alsace
Instituto Alexander Fleming-Alexander Fleming ( Site 0206) Buenos Aires, Buenos Aires F.D.
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258) Concepción, Departamento de Junín
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata, Buenos Aires
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555) Istanbul,
James J. Peters VA Medical Center ( Site 0088) The Bronx, New York
Jiangxi Cancer Hospital ( Site 0386) Nanchang, Jiangxi
Kagawa University Hospital ( Site 0917) Kita, Kagawa-ken
Kagoshima University Hospital ( Site 0929) Kagoshima,
Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California
Kanazawa Medical University Hospital ( Site 0909) Mukai-awagasaki, Ishikawa-ken
Kansai Medical University Hospital ( Site 0912) Hirakata, Osaka
Karolinska Universitetssjukhuset Solna ( Site 1478) Stockholm, Stockholm County
Klinikum Wels-Grieskirchen GmbH ( Site 0279) Wels, Upper Austria
Kobe University Hospital ( Site 0914) Kobe, Hyōgo
Kuopion Yliopistollinen Sairaala ( Site 0603) Kuopio, Northern Savonia
Kurume University Hospital ( Site 0920) Kurume, Fukuoka
Kyushu University Hospital ( Site 0919) Fukuoka,
M Health Fairview Clinics and Surgery Center ( Site 0019) Minneapolis, Minnesota
MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin
Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) Macquarie University, New South Wales
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553) Brno, Brno-mesto
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310) Siedlce, Masovian Voivodeship
Meander Medisch Centrum ( Site 1157) Amersfoort, Utrecht
Medical Care and Research SA de CV ( Site 1108) Mérida, Yucatán
Medische Centrum Leeuwarden ( Site 1172) Leeuwarden, Provincie Friesland
Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280) Graz, Styria
Meir Medical Center. ( Site 0832) Kfar Saba,
Memorial Ankara Hastanesi-Medical Oncology ( Site 1557) Ankara,
Metro-Minnesota Community Clinical Oncology ( Site 0014) Saint Louis Park, Minnesota
Miyazaki Prefectural Miyazaki Hospital ( Site 0927) Miyazaki,
Nagano Municipal Hospital ( Site 0932) Nagano,
Nanbu Tokushukai Hospital ( Site 0930) Shimajiri, Okinawa
Nanchong Central Hospital-urology ( Site 0422) Nanchong, Sichuan
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377) Nanjing, Jiangsu
Nara Medical University Hospital ( Site 0915) Kashihara, Nara
National Cancer Centre Singapore ( Site 1377) Singapore, Central Singapore
National Cancer Institute ( Site 1079) Putrajaya, Putrajaya
National Cheng Kung University Hospital-Urology ( Site 1502) Tainan City,
National Hospital Organization Kumamoto Medical Center ( Site 0924) Kumamoto,
National Hospital Organization Nagasaki Medical Center ( Site 0923) Ōmura, Nagasaki
National Hospital Organization Oita Medical Center ( Site 0925) Ōita,
National Taiwan University Hospital-Urology ( Site 1506) Taipei,
National University Hospital ( Site 1376) Singapore, Central Singapore
Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153) Amsterdam, North Holland
Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761) Salgótarján, Nógrád megye
Obras Sociais Irma Dulce ( Site 0302) Salvador, Estado de Bahia
Ochsner Clinic Foundation ( Site 0108) New Orleans, Louisiana
Odense Universitetshospital-Department of oncology ( Site 0579) Odense, Region Syddanmark
Oncosalud-Clinical Research ( Site 1260) Lima,
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276) Linz, Upper Austria
Oregon Health and Science University ( Site 0028) Portland, Oregon
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756) Budapest, Pest County
Ospedale San Raffaele-Oncologia Medica ( Site 0876) Milan,
Pan American Center for Oncology Trials - Ciudadela ( Site 1351) San Juan,
Peking University First Hospital-Urology ( Site 0390) Beijing, Beijing Municipality
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) Melbourne, Victoria
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354) Santiago, Region M. de Santiago
Prince of Wales Hospital ( Site 0730) Shatin,
Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) Brisbane, Queensland
Princess Margaret Cancer Centre ( Site 0330) Toronto, Ontario
Puerto Rico Medical Research Center LLC ( Site 1354) Hato Rey,
Queen Mary Hospital ( Site 0727) Hong Kong,
Quemex Medical and Research ( Site 1112) Mexico City, Mexico City
Rabin Medical Center ( Site 0828) Petah Tikva,
Radboudumc-Medical Oncology ( Site 1152) Nijmegen, Gelderland
Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina
Rambam Health Care Campus-Oncology Division ( Site 0826) Haifa,
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316) Grudziądz, Kuyavian-Pomeranian Voivodeship
Rigshospitalet ( Site 0576) Copenhagen, Capital Region
Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey
SCRI Oncology Partners ( Site 7000) Nashville, Tennessee
Saga-Ken Medical Centre Koseikan ( Site 0922) Saga, Saga-ken
Sahlgrenska Universitetssjukhuset ( Site 1479) Gothenburg, Västra Götaland County
Samsung Medical Center ( Site 1405) Seoul,
Sanatorio Parque ( Site 0208) Rosario, Santa Fe Province
Sapporo Medical University Hospital ( Site 0902) Sapporo, Hokkaido
Sarawak General Hospital-Radiotherapy Unit ( Site 1076) Kuching, Sarawak
Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408) Hefei, Anhui
Seoul National University Hospital-Oncology ( Site 1401) Seoul,
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404) Seoul,
Sheba Medical Center ( Site 0827) Ramat Gan,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502) Valledupar, Cesar Department
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klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696) Munich, Bavaria

Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

ctrrecruit@vcu.edu

PHASE3
NCT06096844
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Inclusion Criteria:
* STEP 1 REGISTRATION * Patient must be ≥ 70 years of age * Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49% * Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed * Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors * Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 * Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration) * Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration) * Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration) * Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration) * Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial * 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. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral * 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 * Patient must be English or Spanish speaking to be eligible for the QOL component of the study * NOTE: Sites cannot translate the associated GA or QOL forms * Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible * Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration * Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration * Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease * Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible * Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration * Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet) * STEP 2 RANDOMIZATION * Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization
DRUG: Carboplatin, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, DRUG: Pemetrexed, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
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Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
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Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
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Aspirus Regional Cancer Center Wausau, Wisconsin
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Aultman Health Foundation Canton, Ohio Site Public Contact - (ClinicalReserachDept@aultman.com)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
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Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
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Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
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Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
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Kansas City Veterans Affairs Medical Center Kansas City, Missouri
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania Site Public Contact - (nctn@pennmedicine.upenn.edu)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Lankenau Medical Center Wynnewood, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Malcom Randall Veterans Administration Medical Center Gainesville, Florida Site Public Contact - (trials@cancer.ufl.edu)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mayo Clinic Health System-Eau Claire Clinic Eau Claire, Wisconsin
Mayo Clinic Health Systems-Mankato Mankato, Minnesota
Medical University of South Carolina Charleston, South Carolina
Memorial Hospital Marysville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital East Shiloh, Illinois
Mercy Cancer Center-West Lakes Clive, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Coon Rapids, Minnesota
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Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
MetroHealth Medical Center Cleveland, Ohio Site Public Contact - (ababal@metrohealth.org)
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Carmel Grove City Hospital Grove City, Ohio Site Public Contact - (Jeffh@columbusccop.org)
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MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Northwest Cancer Center - Hobart Hobart, Indiana
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Northwest Cancer Center - Valparaiso Valparaiso, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Northwest Oncology LLC Dyer, Indiana
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
Paoli Memorial Hospital Paoli, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
Penn Medicine Princeton Health Plainsboro, New Jersey Site Public Contact - (PennCancerTrials@careboxhealth.com)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Premier Blood and Cancer Center Dayton, Ohio
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
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Reading Hospital West Reading, Pennsylvania
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Riddle Memorial Hospital Media, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
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SSM Health Good Samaritan Mount Vernon, Illinois
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Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Catherine Hospital Indianapolis, Indiana Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Mary Medical Center Hobart, Indiana Site Public Contact - (CancerResearch@COMHS.org)
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
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Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
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Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
Siteman Cancer Center at Christian Hospital St Louis, Missouri
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri
Siteman Cancer Center-South County St Louis, Missouri
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Springfield Regional Cancer Center Springfield, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Stamford Hospital/Bennett Cancer Center Stamford, Connecticut
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Strecker Cancer Center-Belpre Belpre, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
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The Community Hospital Munster, Indiana
The Dana-Farber Cancer Institute at Londonderry Londonderry, New Hampshire Site Public Contact - (ecog.rss@jimmy.harvard.edu)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
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The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
ThedaCare Cancer Care - Berlin Berlin, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - New London New London, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
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ThedaCare Cancer Care - Waupaca Waupaca, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Cancer Center Appleton, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Regional Medical Center - Neenah Neenah, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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Tufts Medical Center Boston, Massachusetts
UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio
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UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UMass Memorial Medical Center - University Campus Worcester, Massachusetts
UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas Site Public Contact - (Suzanne.cole@utsouthwestern.edu)
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University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
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University of Rochester Rochester, New York
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Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut
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Wilmot Cancer Institute at Webster Webster, New York Site Public Contact - (WCICTOresearch@urmc.rochester.edu)
Women's Diagnostic Center - Munster Munster, Indiana Site Public Contact - (mnicholson@comhs.org)

Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm

ctrrecruit@vcu.edu

PHASE2
NCT05600894
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Inclusion Criteria:
* A diagnosis of an MDS/MPN "overlap" syndrome with \>= 5% marrow blasts (including monocytic blast equivalent in case of CMML). Hydroxyurea may be used to control counts up until the start of therapy * White blood cell (WBC) \< 25,000/mm\^3. Treatment with hydroxyurea is permitted to lower the WBC to reach this criterion * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of ASTX727 in combination with venetoclax in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Total bilirubin =\< 1.5 x upper limit of normal (ULN) (unless considered due to Gilbert's syndrome) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN OR =\< 5.0 x institutional ULN for patients with liver metastases * Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * 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. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * 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. Hormonal therapy for prior or concurrent malignancy is allowed * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and/or family member available will also be eligible * Ability to swallow pills
Exclusion Criteria:
* Patients with need for emergent disease-directed therapy excluding hydroxyurea * More than one cycle of previous MDS/MPN-directed therapy, or MDS-directed therapy including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine, excluding hydroxyurea. Prior use of erythropoietin stimulating agents (ESA) and thrombopoietic agents is allowed, but must be discontinued 4 weeks prior to study treatment * Patients currently or previously receiving an investigational agent or device within 4 weeks of the first dose of treatment * Patients with symptomatic uncontrolled central nervous system (CNS) disease. Imaging to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days * Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment and are unwilling to discontinue consumption of these throughout the receipt of study drug * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 or venetoclax * Patients with uncontrolled intercurrent illness (e.g. requiring intravenous therapy) at the discretion of the investigator * Pregnant women are excluded from this study because venetoclax and ASTX727 have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. These potential risks may also apply to other agents used in this study. Patients must be post-menopausal or with evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1 * Post-menopausal is defined as: * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range for women under 50 years of age * Radiation-induced oophorectomy with last menses \> 1 year ago * Chemotherapy-induced menopause with \> 1 year interval since last menses * Surgical sterilization (bilateral oophorectomy or hysterectomy) * Women of child-bearing potential must agree to use adequate contraception (hormonal birth control or abstinence) prior to study entry and for the duration of study participation, and for 6 months following completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception (latex or synthetic condom or abstinence) prior to the study, for the duration of study participation, and 3 months after completion of venetoclax and ASTX727 administration * Patients with any other medical condition for which the expected survival is below 12 months * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or assessment of the investigational regimen * Patients with uncontrolled infection at the time of study entry
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Venetoclax
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Myelodysplastic/Myeloproliferative Neoplasm, Myeloproliferative Neoplasm
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Study Locations

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Location Contacts
Beth Israel Deaconess Medical Center Boston, Massachusetts
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Los Angeles General Medical Center Los Angeles, California
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
NYP/Weill Cornell Medical Center New York, New York
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UC Irvine Health Cancer Center-Newport Costa Mesa, California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UCI Health Laguna Hills Laguna Hills, California Site Public Contact - (ucstudy@uci.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USC / Norris Comprehensive Cancer Center Los Angeles, California
University Health Network-Princess Margaret Hospital Toronto, Ontario Site Public Contact - (clinical.trials@uhn.on.ca)
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Chicago Medicine-Orland Park Orland Park, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio Site Public Contact - (cancer@uchealth.com)
University of Cincinnati Cancer Center-West Chester West Chester, Ohio Site Public Contact - (cancer@uchealth.com)
University of Kansas Cancer Center Kansas City, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer

ctrrecruit@vcu.edu

PHASE2
NCT03606967
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Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and/or radiologic suspicion of metastatic TNBC can be consented prior to this confirmation. * Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor. * HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+. * PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions. * Patients may have measurable or evaluable disease. * Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed metastatic or locally advanced disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ- unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. * No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy. * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 60%). * Body weight \> 30 kg. * Must have a life expectancy of at least 12 weeks. * Absolute neutrophil count \>= 1,500/mcL. * Platelets \>= 100,000/mcL. * Hemoglobin \>= 9.0 g/dL. * Serum bilirubin =\< 1.5 x institutional upper limit of normal. * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\< 5 x institutional upper limit of normal. * Calculated creatinine clearance \> 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance. * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \> 250, and are on a stable antiretroviral regimen. * Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver/guardian.
Exclusion Criteria:
* Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible. * Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study. * Patients who have received prior immunotherapy for metastatic disease. * Patients who have not recovered from grade \>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. * Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician. * Patients with stable endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study. * Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days. * Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab. * Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment. * Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection) * Systemic corticosteroids at physiological doses which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid * Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication). * Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty. * Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 minutes apart). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry. * Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * History of pneumonitis or interstitial lung disease. * History of active primary immunodeficiency. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \[TB\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \[HBV\] surface antigen \[HBsAg\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). * The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: * Patient has undergone potentially curative therapy for all prior malignancies. * Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix). * Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered. * History of allogeneic organ transplantation.
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, PROCEDURE: Computed Tomography, BIOLOGICAL: Durvalumab, DRUG: Gemcitabine Hydrochloride, PROCEDURE: Magnetic Resonance Imaging, DRUG: Nab-paclitaxel, BIOLOGICAL: Personalized Synthetic Long Peptide Vaccine, DRUG: Poly ICLC, BIOLOGICAL: Sacituzumab Govitecan, BIOLOGICAL: Tremelimumab
Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
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Study Locations

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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center - McKinley Campus Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Moffitt Cancer Center-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
NYP/Weill Cornell Medical Center New York, New York
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCHealth University of Colorado Hospital Aurora, Colorado
UM Sylvester Comprehensive Cancer Center at Aventura Aventura, Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania
University of Texas Medical Branch Galveston, Texas Site Public Contact - (clinical.research@utmb.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Wake Forest University at Clemmons Clemmons, North Carolina
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Yale University New Haven, Connecticut

Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy (APPELHUS)

Novartis Pharmaceuticals - novartis.email@novartis.com

PHASE3
NCT04889430
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Main
Inclusion Criteria:
* Adult patients with evidence of active thrombotic microangiopathy (TMA), including thrombocytopenia, evidence of hemolysis, and acute kidney injury * Vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections are required prior to the start of study treatment. If the patient has not been previously vaccinated, or if a booster is required, vaccine should be given according to local regulations, at least 2 weeks prior to first study drug administration. If study treatment has to start earlier than 2 weeks post vaccination or before vaccination is given, prophylactic antibiotic treatment must be administered at the start of study treatment and for at least 2 weeks after vaccination Main
Exclusion Criteria:
* Treatment with complement inhibitors, including anti-C5 antibody * ADAMTS13 deficiency (\<10% activity or \<0.1U/ml), and/or Shiga toxin-related hemolytic uremic syndrome (STx-HUS), and/or Positive direct Coombs test * Identified drug exposure-related HUS or HUS related to known genetic defects of cobalamin C metabolism or known diacylglycerol kinase ε (DGKE) mediated aHUS * Receiving PE/PI, for 14 days or longer, prior to the start of screening for the current TMA * Bone marrow transplantation (BMT)/hematopoietic stem cell transplantation (HSCT), heart, lung, small bowel, pancreas, or liver transplantation * Patients with sepsis or active severe systemic bacterial, viral (including COVID-19) or fungal infection, systemic infection which confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease, active infection (or history of recurrent invasive infections) caused by encapsulated bacteria * Kidney disease suggestive of other disease than aHUS or of chronic kidney failure or family history of non-complement mediated genetic kidney disease * Liver disease or liver injury at screening * Systemic sclerosis (scleroderma), systemic lupus erythematosus (SLE), or antiphospholipid antibody positivity or syndrome * Chronic hemo- or peritoneal dialysis Other protocol-defined inclusion/exclusion criteria may apply
DRUG: Iptacopan
Atypical Hemolytic Uremic Syndrome
LNP023, iptacopan, aHUS, atypical hemolytic uremic syndrome, thrombotic microangiopathy
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Study Locations

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Baylor Scott and White Research Temple, Texas Rachel E DeSantis - (Rachel.DeSantis@BSWHealth.org)
Brigham and Womens Hospital Boston, Massachusetts
Cleveland Clinic Foundation Cleveland, Ohio Marina Markovic - (markovm@ccf.org)
Comprehensive Transplant Ctr at OSU Columbus, Ohio Dahlia Najjar - (Dahlia.Najjar@osumc.edu)
Duke University Medical Center Durham, North Carolina
Georgetown University Lombardi Cancer Center Washington, District of Columbia
Harbor-UCLA Medical Center . Torrance, California Katie LaBarbera - (katie.labarbera@lundquist.org)
Montefiore Medical Center . Bronx, New York
Novartis Investigative Site Ho Chi Minh City,
Novartis Investigative Site Ho Chi Minh City,
Novartis Investigative Site Ho Chi Minh City,
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Novartis Investigative Site Ho Chi Minh City,
Rut Univ for Translational Med Scie New Brunswick, New Jersey
USC Norris Cancer Center Newport Beach, California Hannah Trey - (hannah.trey@med.usc.edu)
UT Southwestern Medical Center Dallas, Texas Elaine Bonilla - (Elaine.Bonilla@UTSouthwestern.edu)
Uni Of Alabama At Birmingham Birmingham, Alabama Jennifer Newby - (jnewby@uabmc.edu)
Univ Cali Irvine ALS Neuromuscular Orange, California
Univ of California at Los Angeles Los Angeles, California Ahad Qureshi - (ahadqureshi@mednet.ucla.edu)
University of Cincinnati Cincinnati, Ohio Kyra Parker - (beckekd@ucmail.uc.edu)
University of Miami Miami, Florida
University of Minnesota Minneapolis, Minnesota
University of New Mexico Albuquerque, New Mexico
Virginia Commonwealth University Richmond, Virginia Tracy McMullin - (tlmcmullin@vcu.edu)
WA Uni School Of Med Saint Louis, Missouri Elizabeth Reimer - (reimer@wustl.edu)

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

PHASE3
NCT06003426
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Inclusion Criteria * Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. * Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. * If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening. * If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. * Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test. * Men who are sexually active with women of childbearing potential agree to use male barrier contraception. Exclusion Criteria * History of stroke or transient ischemic attack within 3 months prior to screening. * Participants who exhibit symptoms of heart failure at rest. * Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986278, DRUG: BMS-986278 Placebo
Idiopathic Pulmonary Fibrosis
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
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Study Locations

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"Corfu General Hospital ""St. IRINI""" Corfu,
"General Hospital of Thessaloniki ""G. Papanikolaou""" Pylaia-Chortiatis, B
"Ospedale ""Gian Battista Morgagni - Luigi Pierantoni"" di Forli" Forlì,
ACE Hospital & Research Center Pune, Maharashtra
AORN - Ospedali dei Colli Ospedale V. Monaldi Napoli,
Aarhus University Hospital Aarhus,
Accellacare US Inc. of Wilmington Wilmington, North Carolina
Ajou University Hospital Suwon,
All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi, National Capital Territory of Delhi
Alliance Pulmonary Group Guaynabo, PR
Amsterdam UMC - Locatie VUMC - Pulmonale Hypertensie (PH) Kenniscentrum Amsterdam,
AnMed Health Oglesby Center - AnMed Health Pulmonary and Sleep Medicine Anderson, South Carolina
Anhui Medical University - Anhui Chest Hospital Hefei, AH
Anhui Medical University - The Second Hospital - Hematological Research Center Hefei, Anhui
Anhui Provincial Hospital Hefei,
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara,
Asan Medical Center (AMC) Songpa-gu, Seoul
Aso Iizuka Hospital Iizuka-shi,
Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille,
Asst Papa Giovanni XXIII Bergamo, Bg
Asthma Bhawan Jaipur, Rajasthan
Athens Medical Center Marousi, Attica
Avanza Medical Research Center Pensacola, Florida
Azienda Ospedaliera San Paolo Milan,
Azienda Ospedaliera Universitaria - Universita di Sassari Sassari,
Azienda Ospedaliero - Universitaria di Modena Policlinico Modena, Emilia-Romagna
Azienda Ospedaliero Universitaria Pisana Pisa,
Azienda Ospedaliero Universitaria delle Marche Ancona, AN
Azienda Ospedaliero-Universitaria Careggi Florence, FI
Baylor College of Medicine Medical Center - Pulmonary, Critical Care, and Sleep Medicine Houston, Texas
Baylor University Medical Center at Dallas Dallas, Texas
Beijing Chaoyang Hospital, Capital Medical University Beijing, Beijing Municipality
Beijing Friendship Hospital, Capital Medical University Beijing, BJ
Bioreuma Concepción, Bio Bio
Brightshores Health System Owen Sound, Ontario
Burlington Lung Clinic Burlington, Ontario
C.I.C. Joliette Saint-Charles-Borromée, Quebec
C.I.C. Mauricie Inc. Trois-Rivières, Quebec
CEC Centros Estudios Clinicos Santiago, RM
CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo Do Campo/SP,
CENRESIN - Centro Respiratorio Integral Quillota, Región de Valparaíso
CHRU de Tours - Hôpital Bretonneau Tours,
CHU Dijon - Hôpital François Mitterrand Dijon,
CHU Hopitaux de Bordeaux - Hopital Haut-Leveque Pessac,
CHU UCL Namur - Mont-Godinne Yvoir, Namur
CHU de Brest - Hôpital Cavale Blanche Brest,
CHU de Nantes - Hôpital Nord Laennec Nantes, Pays de la Loire Region
Carmel Medical Center Haifa, Haifa District
Center Hospital of the National Center for Global Health and Medicine Shinjyu-Ku,
Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes) Grenoble, Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire d'Angers Angers, Pays de la Loire Region
Centre Hospitalier Universitaire de Liege - Sart Tilman Liège,
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Centro Medico Santa Maria Barra Mansa, Rio de Janeiro
Centro Medico de Enfermedades Respiratorias Florida, B
Centro Respiratorio Quilmes Quilmes, Provincia de Buenos Aires, B
Centro de Estudos de Pneumologia da Faculdade de Medicina do ABC (CEPFMABC) Santo André, São Paulo
Centro de Investigacion Clinica de Oaxaca (CICLO) Oaxaca City, Oaxaca
Centro de Investigacion Curico Curicó, Maule Region
Centro de Investigaciones Metabólicas (CINME) Buenos Aires,
Centro de Investigación Clínica Chapultepec S.A. de C.V. Morelia, Michoacán
Centro de Investigación del Maule Talca, Maule Region
Centrum Medycyny Oddechowej Bialystok, Podlaskie Voivodeship
Chang Gung Medical Foundation - Kaohsiung Branch Kaohsiung City, Kao-Hsiung
Changhua Christian Hospital Changhua,
Chiba University Hospital Chiba, Chiba
China Medical University Hospital Taichung,
Christiana Care Pulmonary Associates - Newark Newark, Delaware
Clinica 25 de Mayo Mar del Plata, B
Clinica Providencia San Miguel, LIM
Clinica Universidad de Navarra Pamplona, Navarre
Clinica Universidad de los Andes Santiago, RM
Clinical Research Specialists, LLC - Kissimmee Kissimmee, Florida
Cliniques Universitaires Saint-Luc Brussels,
Clínica Universidad de Navarra -Madrid Madrid,
Clínica de día Jockey Salud Lima, LIM
Coastal Pulmonary & Critical Care, P.L.C. St. Petersburg, Florida
Connolly Hospital Blanchardstown Dublin,
Consultorios Médicos del Buen Ayre Caba, B
David Geffen School of Medicine at UCLA Los Angeles, California
Diex Recherche - Trois-Rivieres Trois-Rivières, Quebec
Dokuz Eylul Universitesi Tip Fakultesi Pasaport,
Duke University Medical Center Durham, North Carolina
Ege Universitesi Tip Fakultesi Hastanesi (Ege University Medical Faculty Hospital) Izmir,
Erasmus MC - Centrum voor Interstitiele Longziekten Rotterdam, South Holland
Erciyes University School of Medicine Kayseri,
Escola Paulista de Medicina São Paulo,
Fachkrankenhaus Coswig GmbH Coswig,
Far Eastern Memorial Hospital New Taipei City,
Fiona Stanley Hospital Murdoch,
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan,
Fondazione IRCCS Policlinico San Matteo Pavia,
Fondazione IRCCS San Gerardo dei Tintori Monza, Monza and Brianza
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fortis Hospital Mohali Mohali, Punjab
Fundacion Enfisema - Instituto Ave Pulmo Mar del Plata, Buenos Aires
Fundacion Respirar Buenos Aires,
Fundacion Santa Fe de Bogota Bogotá,
Fundacion Scherbovsky Mendoza, M
Gachon University - Gil Medical Center Incheon,
Gallipoli Medical Research Centre - Clinical Trials Unit (CTU) Greenslopes, Queensland
Gentofte Hospital Hellerup,
Getwell Hospital and Research Institute - Lungs Care Nagpur, Maharashtra
Giromed Institute, SLP Barcelona,
Grant Medical Foundation - Ruby Hall Clinic Pune,
Green City Hospital Bhopal, Madhya Pradesh
Guy's and St Thomas' NHS Foundation Trust - Royal Brompton Hospital London, Greater London
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Győr,
HELIOS Klinikum Emil von Behring Berlin, State of Berlin
Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem Jerusalem,
Hamamatsu University Hospital Hamamatsu-shi, Shizuoka,
Hangzhou First People's Hospital Hangzhou, ZJ
Harmony Medical Research Institute, Inc Hialeah, Florida
Health SURA Calle 100 Bogotá, DC
Health SURA Chipichape Santiago de Cali, VAC
Helsinki University Hospital Heart and Lung Center Helsinki, Etelae-Suomen Laeaeni
Henan provincial people's hospital Zhengzhou, HA
Hiroshima Prefectural Hospital Hiroshima, Hirohima-ken
Hopital Avicenne Bobigny,
Hopitaux Universitaires de Geneve (HUG) Geneva, Canton of Geneva
Hospices Civils de Lyon Bron, Auvergne-Rhône-Alpes
Hospital Alemao Oswaldo Cruz (HAOC) - Centro de Oncologia (Oncology Center) São Paulo,
Hospital CUF Tejo Lisbon,
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico San Carlos Madrid,
Hospital Clinico Universitario Madrid,
Hospital Dia do Pulmão Blumenau, Santa Catarina
Hospital Ernesto Dornelles (HED) Porto Alegre, Rio Grande do Sul
Hospital Madre Teresa Belo Horizonte, Minas Gerais
Hospital Nacional Cayetano Heredia Lima,
Hospital Universitari de Bellvitge (IDIBELL) Barcelona,
Hospital Universitario Central de Asturias Oviedo, Principality of Asturias
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Puerta De Hierro - Majadahonda Majadahonda, M
Hospital Universitario de La Princesa Madrid,
Hospital das Clínicas da Universidade Federal de Minas Gerais (UFMG) Belo Horizonte, Minas Gerais
Hospital de Santa Marta Lisbon,
Huadong Hospital Affiliated to Fudan University Shanghai, Shanghai Municipality
Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital Cottingham, Yorkshire and the Humber
Hôpital Bichat - Claude-Bernard Paris, Île-de-France Region
Hôpital Larrey Toulouse,
Ibamedica Santa Fe,
Inje University Busan Paik Hospital Busan,
Inje University Haeundae Paik Hospital Busan,
Inje University Ilsan Paik Hospital Goyang-si,
Inselspital - Universitaetsklinik Bern für Pneumologie Bern, Canton of Bern
Inspiration Research Toronto, Ontario
Institute for Respiratory Health Nedlands, Western Australia
Institute of Science Tokyo Hospital Bunkyo-Ku, Tokyo
Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM) San Juan Bautista, Buenos Aires
Instituto Medico DAMIC Córdoba,
Instituto Medico INSARES SA Mendoza, M
Instituto Medico de la Fundacion de Estudios Clínicos Rosario, S
Instituto Neumologico del Oriente Floridablanca, Santander Department
Instituto de Seguridad Social del Estado de Mexico y Municipios (ISSEMYM) - Centro Medico Toluca Metepec, Edo De Mexico
Investigaciones en Patologias Respiratorias San Miguel de Tucuman, Tucumán, T
Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi Topkapı,
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Palermo,
Jehangir Clinical Development Center Pune, Maharashtra
Jichi Medical University Hospital Tochigi,
Jizankai Medical Foundation Tsuboi Cancer Center Hospital Koriyama-shi, Fukushima
Juntendo University Hospital Bunkyo-ku, Tokyo
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi, Karnataka
Kameda Medical Center - Kameda Clinic Kamogawa-shi, Chiba
Kanagawa Cardiovascular and Respiratory Center Yokohama,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Kaplan Medical Center Rehovot, Central District
Kepler Universitatsklinikum Linz, Upper Austria
Kindai University Hospital Osakasayama-shi, Osaka
King George's Medical University Lucknow, Uttar Pradesh
Klinikum der Universitat Munchen Munich, Bavaria
Kobe City Medical Center General Hospital Kobe,
Krankenhaus Hietzing Vienna,
Krankenhaus der Augustinerinnen- Klinik fuer Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Cologne, Northwest
Kurume University Hospital Kurume-shi, Fukuoka
Kyorin University Hospital Mitaka-shi, Tokyo-to
Kyushu University Hospital Fukuoka,
Lankenau Medical Center Wynnewood, Pennsylvania
Layrek Clinical Research Tulsa, Oklahoma
Leeds Teaching Hospitals NHS Trust Leeds, West Yorkshire
Local Institution - 0001 Lenexa, Kansas
Local Institution - 0006 São Paulo,
Local Institution - 0008 Munster, Northwest
Local Institution - 0014 Antwerpen, VAN
Local Institution - 0016 Lima, LIM
Local Institution - 0020 Badalona, Barcelona
Local Institution - 0032 Pittsburgh, Pennsylvania
Local Institution - 0043 Changchun, Jilin
Local Institution - 0055 Lima,
Local Institution - 0060 Gainesville, Florida
Local Institution - 0063 Brno, JM
Local Institution - 0070 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0071 L'Hospitalet Del Llobregat, Barcelona [Barcelona]
Local Institution - 0076 Bedzin,
Local Institution - 0078 Monterrey, Nuevo León
Local Institution - 0080 Providencia, RM
Local Institution - 0081 Rennes,
Local Institution - 0082 Vienna,
Local Institution - 0087 Richmond, Virginia
Local Institution - 0091 Nice,
Local Institution - 0094 Evanston, Illinois
Local Institution - 0100 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0104 Atlanta, Georgia
Local Institution - 0112 Toronto, Ontario
Local Institution - 0115 Trieste, TS
Local Institution - 0116 Deagu, Taegu-Kwangyǒkshi
Local Institution - 0133 Milano, MI
Local Institution - 0136 Guadalajara, JAL
Local Institution - 0141 Aguascalientes, AGU
Local Institution - 0148 Katowice,
Local Institution - 0156 Piura, PIU
Local Institution - 0157 Valencia, Comunidad Valencia
Local Institution - 0162 Monterrey, Nuevo Leon
Local Institution - 0163 Córdoba, VER
Local Institution - 0179 Jasper, Alabama
Local Institution - 0182 Chicago, Illinois
Local Institution - 0190 Buffalo, New York
Local Institution - 0192 Milwaukee, Wisconsin
Local Institution - 0195 Springfield, Massachusetts
Local Institution - 0203 Exeter, South West
Local Institution - 0208 Edmonton, Alberta
Local Institution - 0212 Talcahuano, BI
Local Institution - 0217 Sherbrooke, Quebec
Local Institution - 0219 Exeter, South West
Local Institution - 0223 Chongqing, Chongqing Municipality
Local Institution - 0234 Mérida, YUC
Local Institution - 0245 Nagpur, Maharashtra
Local Institution - 0248 Guadalajara, JAL
Local Institution - 0253 Melbourne, Victoria
Local Institution - 0277 Uppsala, Uppsala Län [se-03]
Local Institution - 0280 Helsinki,
Local Institution - 0281 Oulu, North Ostrobothnia
Local Institution - 0293 Darlinghurst, New South Wales
Local Institution - 0296 Zhengzhou Shi, Henan
Local Institution - 0303 Murdoch, Western Australia
Local Institution - 0308 Paris,
Local Institution - 0310 Milano, MI
Local Institution - 0311 Lille CEDEX,
Local Institution - 0312 Incheon,
Local Institution - 0315 Stuttgart, BW
Local Institution - 0316 Deogyang-Gu, Goyang-Si,
Local Institution - 0317 Kitakyushu-shi, Fukuoka-Ken
Local Institution - 0327 Sapporo, Hokkaido
Local Institution - 0329 Okayama,
Local Institution - 0340 Olomouc,
Local Institution - 0357 Gosford, New South Wales
Local Institution - 0376 Yinchuan,
Local Institution - 0381 London, LND
Local Institution - 0384 Koblenz, Rhineland-Palatinate
Local Institution - 0387 Linz,
Local Institution - 0390 Zagreb, City of Zagreb
Local Institution - 0392 Sofia,
Local Institution - 0397 Keçiören/Ankara,
Local Institution - 0399 Lima, LIM
Local Institution - 0401 Miami, Florida
Local Institution - 0412 A Coruña, A Coruña [La Coruña]
Local Institution - 0413 Guadalajara,
Local Institution - 0422 Ankara,
Local Institution - 0423 Kitakyushu-shi, Fukuoka
Local Institution - 0427 Singapore, Central Singapore
Local Institution - 0432 George Town, Pulau Pinang
Local Institution - 0435 Louisville, Kentucky
Local Institution - 0439 Boston, Massachusetts
Local Institution - 0443 Box Hill, Victoria
Local Institution - 0444 Hermosillo, Sonora
Local Institution - 0445 Guadalajara, Jalisco
Local Institution - 0446 Buenos Aires,
Local Institution - 0447 Santiago,
Local Institution - 0448 Guadalajara, Jalisco
Local Institution - 0449 Ampang, Selangor
Local Institution - 0450 Heraklion, Iraklio Kritis
Local Institution - 0451 Keçiören/Ankara,
Local Institution - 0452 Atlanta, Georgia
Local Institution - 0453 Lembah Pantai, Kuala Lumpur
Local Institution - 0454 Pilea Chortiatis, Thessaloniki
Local Institution - 0455 Seongnam,
Local Institution - 0460 Graz, Styria
Local Institution - 0462 Auckland,
Local Institution - 0463 Hermosillo, Sonora
Local Institution - 0464 Pilea Chortiatis, Thessaloniki
Local Institution - 0465 Tacoma, Washington
Local Institution - 0466 Pittsburgh, Pennsylvania
Local Institution - 0467 Darlinghurst, New South Wales
Local Institution - 0468 Santiago,
Local Institution - 0469 Rock Hill, South Carolina
Local Institution - 0471 Coimbatore, Tamil Nadu
Local Institution - 0474 Chermside, Queensland
Local Institution - 0475 Eiheiji-cho,Yoshida-gun, Fukui
Local Institution - 0476 Engenho Velho da Federação, Salvador
Local Institution - 0487 Solna, Stockholms Län [se-01]
Local Institution - 0489 Seville,
Local Institution - 0493 Chihuahua,
Local Institution - 0494 Guadalajara, Jalisco
Local Institution - 0499 Chermside, Queensland
Local Institution - 0500 Hyderabad, TG
Local Institution - 0501 Newport Beach, California
Local Institution - 0504 Halle, Saxony-Anhalt
Loyola University Health System Maywood, Illinois
Lungenfachklinik Immenhausen Immenhausen, Hesse
MICS Centrum Medyczne Bydgoszcz Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Marengo CIMS Hospital Ahmedabad, Gujarat
Massachusetts General Hospital Boston, Massachusetts
Mater Misericordiae Limited South Brisbane, Queensland
Matsusaka Municipal Hospital Matsusaka-shi, Mie-ken
Max Super Specialty Hospital, Saket - West Block - A Unit of Max Healthcare Institute Limited New Delhi, National Capital Territory of Delhi
McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location Houston, Texas
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical University of South Carolina- College of Medicine Charleston, South Carolina
Medicos Internistas de Caldas Manizales, CL
Mercy St. Vincent Medical Center Toledo, Ohio
Meris Clinical Research Brandon, Florida
Metroplex Pulmonary and Sleep Center McKinney, Texas
Midland Healthcare & Research Center Lucknow,
Monteregie Centre de Recherche Greenfield Park, Quebec
Myongji Hospital Goyang-si, Gyeonggi-do
NHS Lothian - Royal Infirmary of Edinburgh Edinburgh, EDH
NHS Tayside Dundee, DND
NZOZ Przychodnia Vitamed Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Nagasaki University Hospital Nagasaki,
Nagoya University Hospital Showa-Ku Nagoya,
Nanfang Hospital of Southern Medical University Guangzhou, Guangdong
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing, JS
National Hospital Organization - Okinawa National Hospital Ginowan-Shi, Okinawa
National Hospital Organization Himeji Medical Center Himeji-Shi, Hyōgo
National Hospital Organization Ibarakihigashi National Hospital Naka-gun, Gunma
National Hospital Organization Kinki-Chuo Chest Medical Center Sakai,
National Hospital Organization Kyushu Medical Center Fukuoka,
National Jewish Health Denver, Colorado
National Taiwan University Hospital - The National Center of Excellence for Clinical Trial Taipei,
National Taiwan University Hospital Yun-Lin Branch Douliu Shi, YUN
Nilratan Sircar (NRS) Medical College & Hospital Kolkata, West Bengal
Nippon Medical School Hospital Bunkyo-ku, Tokyo
North Bristol NHS Trust - Southmead Hospital Bristol Bristol, BST
Northern Westchester Hospital Mount Kisco, New York
Northwestern Memorial Hospital Chicago, Illinois
Norton Pulmonary Specialists Louisville, Kentucky
OSF Saint Francis Medical Center Peoria, Illinois
OU Health Sciences Center - OU Health Physicians - Cardiology, Pulmonary & Vascular Medicine Clinic Oklahoma City, Oklahoma
Ocala Lung & Critical Care Ocala, Florida
Odense Universitetshospital - Svendborg Sygehus Odense C, Region Syddanmark
Omega Research Consultants LLC DeBary, Florida
Oregon Health & Science University - Pulmonary Clinic Portland, Oregon
Ospedale Colonnello D'Avanzo Foggia Foggia,
Ospedale Policlinico di Siena Siena,
Our Lady of Lourdes Hospital - Drogheda Drogheda, LH
Oxford University Hospitals NHS Trust - Churchill Hospital Oxford, Oxfordshire
Papworth Hospital NHS Foundation Trust Cambridge, Cambridgeshire
Peking Union Medical College Hospital Beijing,
Peking University Shenzhen Hospital Shenzhen, Guangdong
Peninsula Health - Frankston Hospital Frankston, Victoria
Penn Medicine - Perelman Center for Advanced Medicine Philadelphia, Pennsylvania
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania
Peterborough City Hospital Peterborough,
Policlínica Piquet Carneiro, Universidade do Estado do Rio de Janeiro Rio de Janeiro, Rio de Janeiro
Praxis fur Pneumologie Marburg, HE
Pulmonary Group of Central Florida, LLC - Leesburg Leesburg, Florida
Pulmonary Specialists of the Palm Beaches Loxahatchee Groves, Florida
Pulmonology, Sleep, Asthma & Allergy Center of Dublin Dublin, Georgia
Qilu Hospital of Shandong University Jinan, Shandong
Quebec Heart and Lung Institute Quebec,
Rabin Medical Center - Hasharon Hospital Petah Tikva,
Rambam Health Care Campus - Pulmonology Haifa,
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - South Branch Shanghai, SH
Renmin Hospital of Wuhan University Wuhan,
Respira Salud Clinica Integral Godoy Cruz, M
Royal Adelaide Hospital Adelaide, South Australia
Royal Prince Alfred Hospital Camperdown, New South Wales
Rush University Medical Center - Rush Pulmonary and Critical Care Medicine - Professional Building Chicago, Illinois
SALK - Universitatsklinik Fur Pneumologie/ Lungenheilkunde Landeskrankenhaus Salzburg, Salzburger Land
Saiseikai Kumamoto Hospital Kumamoto,
Santa Casa de Misericórdia de Porto Alegre - Hospital Sao Jose Porto Alegre, Rio Grande do Sul
Santiago Clinic Hospital (Hospital Clínico Universitario de Santiago -CHUS) Santiago de Compostela, Galicia
Sapporo Medical University Hospital Sapporo, Hokkaido
Scripps Clinic Torrey Pines La Jolla, California
Semmelweis Egyetem Pulmonologiai Klinika Budapest,
Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do,
Seoul National University Hospital Seoul,
Servicios de Salud IPS Suramericana S.A.S - IPS Sura Industriales Medellín Medellín, ANT
Shanghai Jiao Tong University - Shanghai Chest Hospital Shanghai, SH
Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,
Shanghai Pulmonary Hospital Shanghai, Shanghai Municipality
Shengjing Hospital of China Medical University Shengyang,
Shenyang Chest Hospital Shenyang, Liaoning
Shenzhen People's Hospital Shenzhen,
Shimane University Hospital Izumo-Shi,
Shree Hospital and Critical Care Centre Nagpur, MH
Shri Guru Ram Rai (SGRR) Institute of Medical and Health Sciences - Shri Mahant Indiresh Hospital Dehradun, Uttarakhand
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital Chengdu,
SoonChunHyang University Bucheon Hospital Bucheon-si,
SoonChunHyang University Seoul Hospital Yongsan-gu, Seoul
South Texas Veterans Health Care System - Audie L. Murphy VA Hospital San Antonio, Texas
Southeastern Research Center Winston-Salem, North Carolina
St Francis Sleep Allergy & Lung Institute Clearwater, Florida
St. Antonius Ziekenhuis Nieuwegein,
St. John's Medical College Bangalore,
St. Joseph's Healthcare Hamilton Hamilton, Ontario
St. Joseph's Hospital and Medical Center Phoenix, Arizona
St. Paul's Hospital Vancouver, British Columbia
St. Vincent's University Hospital Dublin,
Stanford University School of Medicine Stanford, California
Steward St. Elizabeth Medical Center Boston, Massachusetts
Synergy Respiratory & Cardiac Care Sherwood Park, Alberta
T.C.S.B. Süreyyapasa Gögüs Hastaliklari Egitim Ve Arastirma Hastanesi Maltepe,
TC Saglik Bakanlig -Izmir Dr.Suat Seren Gogus Hastaliklari Ve Cerrahisi Egitim Arastirma Hastanesi Izmir,
Taichung Veterans General Hospital Taichung, China
Taipei Veterans General Hospital Taipei,
Tel Aviv Sourasky Medical Center Tel Aviv,
Temple University Hospital (TUH) - Temple Lung Center (TLC) Philadelphia, Pennsylvania
Tenri Hospital Tenri,
The Affiliated Hospital of Inner Mongolia Medical University Hohhot, Inner Mongolia
The Affiliated Hospital of Xuzhou Medical University Xuzhou, Jiangsu
The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon-si, Gyeonggi-do
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The First Affiliated Hospital of Nanchang University - Xianghu District Nanchang, JX
The First Affiliated Hospital of Ningbo University Ningbo, Zhejiang
The First Affiliated Hospital of Soochow University Suzhou,
The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan
The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong
The First Hospital of China Medical University Shenyang, Liaoning
The Jikei University Hospital Tokyo,
The Lung Centre Vancouver, British Columbia
The Lung Research Center Chesterfield, Missouri
The Ohio State University Wexner Medical Center Columbus, Ohio
The Prince Charles Hospital Brisbane, Queensland
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou, Zhejiang
The Second Hospital of Hebei Medical University Shijiazhuang, Hebi
The Second Xiangya Hospital of Central South University Changsha,
The Third Hospital of Hebei Medical University Shijiazhuang,
The University of Alabama at Birmingham Birmingham, Alabama
The University of Chicago Medicine Chicago, Illinois
Thomas Jefferson University Hospital - Jane and Leonard Korman Lung Center Philadelphia, Pennsylvania
Thoraxklinik-Heidelberg gGmbH Heidelberg,
Thoraxzentrum Bezirk Unterfranken Münnerstadt, Bavaria
Tianjin Chest Hospital Tianjin, Tianjin Municipality
Tianjin Medical University General Hospital Tianjin,
Toho University - Omori Medical Center Tokyo,
Tokyo Medical University Hospital Shinjuku-Ku,
Toranomon Hospital Minato-ku, Tokyo
Tosei General Hospital Seto,
Turun Yliopistollinen Keskussairaala (TYKS) Turku, Laensi-Suomen Laeaeni
UC Irvine Medical Center Orange, California
UPMC - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD) Pittsburgh, Pennsylvania
UZ Leuven Leuven,
Ulsan University Hospital (UUH) Dong-gu, Ulsan
Uludag Universitesi Tip Fakultesi (Uludag University Faculty of Medicine) Bursa,
Unidade Local de Saude de Gaia/Espinho, EPE Vila Nova de Gaia,
Unidade Local de Saude de Loures - Odivelas, E. P. E. Loures,
Unidade Local de Saude de Santa Maria, EPE - Hospital Pulido Valente Lisbon,
Unidade Local de Saude de Santo Antonio, E.P.E. Porto,
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto,
Unidade Local de Saúde do Algarve, EPE Faro,
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan, Hubei
Unity Hospital Fridley, Minnesota
Universitaetsklinikum Essen - Ruhrlandklinik Essen, North Rhine-Westphalia
Universitaetsklinikum Freiburg - Klinik fuer Pneumologie Freiburg I. Breisgau, Baden-Wurttemberg
Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Pneumologie Leipzig,
University General Hospital Attikon Athens, Attica
University Hospitals Birmingham NHS Foundation Trust - Heartlands Hospital Birmingham, BIR
University Hospitals Birmingham NHS Foundation Trust - New Queen Elizabeth Hospital Birmingham Birmingham,
University of California UC Davis Medical Center Sacramento, California
University of California, San Francisco Medical Center- Pulmonary Practice San Francisco, California
University of Cincinnati College of Medicine Cincinnati, Ohio
University of Colorado Anschutz Medical Campus - Department of Family Medicine Aurora, Colorado
University of Florida (UF) Health Shands Hospital Gainesville, Florida
University of Fukui Hospital Yoshida-gun, Fukui
University of Iowa Hospitals and Clinics Iowa City, Iowa
University of Kansas Medical Center (KUMC) Kansas City, Kansas
University of Maryland - Marlene and Stewart Greenebaum Cancer Center Baltimore, Maryland
University of Michigan Ann Arbor, Michigan
University of Patras - Rio Regional University Hospital Rio,
University of South Florida Tampa, Florida
University of Southern California (USC) - Keck School of Medicine (KSOM) - Transplant Clinic Los Angeles, California
University of Texas Southwestern Medical Center - Pulmonary Specialty Clinic Dallas, Texas
University of Thessaly- General University Hospital of Larissa Larissa,
University of Ulsan College of Medicine - Ulsan University Hospital (UUH) Dong-Gu,
University of Utah, University Hospital Salt Lake City, Utah
University of Washington Medical Center Seattle, Washington
Universitätsklinikum Hamburg-Eppendorf (UKE) Hamburg,
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz,
Universitätsspital Basel Basel, Canton of Basel-City
Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego Lodz,
Uniwersyteckie Centrum Kliniczne Gdansk, Pomeranian Voivodeship
VCU Medical Center Richmond, Virginia
Vanderbilt Lung Institute - One Hundred Oaks Nashville, Tennessee
Velocity Clinical Research Germany GmbH Ahrensburg,
Vivantes Klinikum Neukolln Berlin,
Vzw Az Groeninge Kortrijk,
WM Clinica Pneumologica Sociedade Simples LTDA Porto Alegre, Rio Grande do Sul
Warminsko-Mazurskie Centrum Chorób Pluc w Olsztynie Olsztyn, Warmian-Masurian Voivodeship
Washington University School of Medicine in St. Louis St Louis, Missouri
West China Hospital, Sichuan University Chengdu, Sichuan
Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location Everett, Washington
Westmead Hospital Sydney, New South Wales
Wiener Gesundheitsverbund - Klinik Floridsdorf Vienna,
Wonkwang University Hospital Iksansi,
Wuxi People's Hospital Wuxi,
Xi'an International Medical Center Hospital Xi'an, Shan3xi
Yale New Haven Hospital New Haven, Connecticut
Yichang Central People's Hospital - Xiling Campus Yichang Shi, HE
Yonsei University Health System, Severance Hospital Seoul,
Zuyderland Medisch Centrum, Sittard-Geleen Heerlen,
hospital Italiano de Buenos Aires CABA,

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Iovance Biotherapeutics https://www.tilvance-301.com - Clinical.Inquiries@iovance.com

PHASE3
NCT05727904
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Inclusion Criteria:

• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
• In the investigator's assessment, the participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
• Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
• Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
• Participants must have adequate organ function.
• Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
• Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
Exclusion Criteria:

• Participant has melanoma of uveal/ocular origin.
• Participant has symptomatic untreated brain metastases.
• Participant received more than 1 prior line of therapy.
• Participant received prior therapy for metastatic disease
• Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
• Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
• Participant has a history of allogeneic cell or organ transplant. Other protocol defined inclusion/exclusion criteria could apply.
BIOLOGICAL: Lifileucel plus Pembrolizumab, BIOLOGICAL: Pembrolizumab with Optional Crossover Period
Metastatic Melanoma, Unresectable Melanoma, Melanoma
Tumor Infiltrating Lymphocytes, TIL, Metastatic Melanoma, Unresectable Melanoma, Cell Therapy, Cellular Immuno-therapy, IL-2, Non-myeloablative lymphodepletion (NMALD), Check point inhibitor, Melanoma, Lifileucel, Stage III Melanoma, Stage IV Melanoma, Skin cancer, Skin cancer types, Malignant melanoma, Autologous Adoptive Cell Therapy, Autologous Adoptive Cell Transfer, LN-144, Pembrolizumab, Pembro, Adjuvant/Neo-adjuvant, BRAF/MEK, ICI, BRAF v600, Immune checkpoint inhibitor, Tumor infiltrating T-cells, TILVANCE, TILVANCE-301
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Study Locations

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Location Contacts
Allegheny Health Network Pittsburgh, Pennsylvania
Azienda Ospedaliera Universitaria Senese Siena, Si
Azienda Ospedaliero Universitaria Pisana Pisa,
Baptist Cancer Center Memphis, Tennessee
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center Detroit, Michigan
Beaston West of Scotland Canter Centre Glasgow,
Bundang Medical Center - CHA University Seongnam-si, Gyeonggi-do
California Pacific Medical Center San Francisco, California
Centre Hospitalier Universitaire Vaudois Lausanne Lausanne,
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu Nantes,
Centre Hospitalier de l'Université de Montréal Montreal, Quebec
Centro di Riferimento Oncologico IRCCS Aviano, Friuli-Venezia Giulia
City of Hope Duarte, California
Clinica Universitaria de Navarra Pamplona,
Consorcio Hospital General Universitario de Valencia Valencia,
Dartmouth-Hitchcock Medical Center (DHMC) - Norris Cotton Cancer Center Lebanon, New Hampshire
Fiona Stanley Hospital Murdoch,
Flinders Medical Centre Bedford Park, South Australia
Freeman Hospital Newcastle upon Tyne,
Greenslopes Private Hospital Greenslopes, Queensland
Guy's Hospital London,
Hadassah Medical Center Jerusalem,
Henry Ford Health Detroit, Michigan
Hopital Saint Louis Paris,
Hospital 12 de Octubre Madrid,
Hospital Clinic de Barcelona Barcelona,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Regional Universitario de Malaga - Hospital General Malaga, Málaga
Hospital Universitari Vall dHebron Barcelona,
Hospital Universitario Madrid Sanchinarro - CIOCC Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen Macarena Seville, Andalusia
ICO l'Hospitalet - Hospital Duran i Reynals Barcelona,
Institut Paoli Calmettes Marseille,
Instituto Oncologico Rosell Barcelona,
Istituto Europeo Di Oncologia Milan, Milan
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Napoli,
Istituto Romagnolo per lo Studio dei Tumori Meldola, Forli Cesena
Klinikum rechts der Isar der Technischen Universitat Munchen Munich,
MD Anderson Cancer Center at Cooper Camden, New Jersey
National Cancer Institute Bangkok,
Nederlands Kanker Instituut Amsterdam,
Ohio State University Columbus, Ohio
Oncology Hematology Care Cincinnati, Ohio
Orlando Health Cancer Institute Orlando, Florida
Peter MacCallum Cancer Centre Melbourne, Victoria
Princess Margaret Cancer Centre Toronto, Ontario
Queen Elizabeth Hospital Birmingham Birmingham,
Royal Marsden Hospital Sutton,
SCRI Oncology Partners Nashville, Tennessee
Sahlgrenska Universitetssjukhuset Gasteborg,
Sarah Cannon Research Institute UK London,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Sheba Medical Center Ramat Gan,
St. Luke's Cancer Center - Anderson Easton, Pennsylvania
Swedish Cancer Institute Seattle, Washington
Tel Aviv Sourasky Medical Center Tel Aviv,
USC Norris Comprehensive Cancer Center Los Angeles, California
Universitair Ziekenhuis Brussel - Oncologisch Centrum Jette,
Universitatsklinikum Hamburg-Eppendorf Hamburg,
University of Alabama at Birmingham: The Kirklin Clinic Birmingham, Alabama
University of Colorado Cancer Center Aurora, Colorado
University of Illinois Hospital & Health Sciences System Chicago, Illinois
University of Kansas Kansas City, Kansas
University of Louisville - James Graham Brown Cancer Center Louisville, Kentucky
Universitätsklinikum Carl Gustav Carus Dresden,
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck,
Virginia Commonwealth University Richmond, Virginia
Westmead Hospital Sydney, New South Wales

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

ctrrecruit@vcu.edu

PHASE2
NCT05987241
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Inclusion Criteria:
* PRE-REGISTRATION: Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis * PRE-REGISTRATION: Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer) * PRE-REGISTRATION: Patient must have had radical surgery (i.e., cystectomy and lymph node dissection or nephroureterectomy or ureterectomy) ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible * PRE-REGISTRATION: No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., "positive margins") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins * PRE-REGISTRATION: No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration) * PRE-REGISTRATION: Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.: * (i) Patients who have not received neoadjuvant systemic therapy: pT3-pT4\* or pT0/x-pT4/N+ on radical surgery (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy * (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented: * (i) Creatinine Clearance (using Cockcroft-Gault): \< 60 mL/min * (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \>= 2 audiometric hearing loss * (i) CTCAE version 5, grade \>= 2 or above peripheral neuropathy * New York Heart Association Class III heart failure * (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2 * (i) Patients who are eligible for cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented. * (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results based on an assay performed post-radical surgery as part of routine care outside of the study may proceed with pre-registration but require confirmation of ctDNA(+) Signatera testing on repeat "central testing" in the context of A032103 testing. Patients with pT2N0 with central testing not confirming ctDNA(+) will not be eligible for A032103 (Note: this is distinct from patients with ypT2N0 who are eligible based on ii). * (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4a and/or ypN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade * PRE-REGISTRATION: Available tumor tissue for central Signatera testing to be submitted at pre-registration. Central testing is defined as testing performed as part of the A032103 study prior to registration and is provided by the study and not routine standard commercial testing. Patients who have already had local Signatera testing performed as part of routine care will require repeat central testing as part of the A032103 study to be eligible for registration/randomization. Tumor tissue from the radical surgery specimen is preferred over tissue from prior diagnostic biopsy specimen (e.g., transurethral resection of bladder tumor specimen) * PRE-REGISTRATION: Age \>= 18 years * PRE-REGISTRATION: ECOG Performance Status 0-2 * PRE-REGISTRATION: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * PRE-REGISTRATION: No postoperative/adjuvant systemic therapy after radical surgery * PRE-REGISTRATION: No adjuvant radiation after radical surgery * PRE-REGISTRATION: No treatment with any other type of investigational agent =\< 4 weeks before pre-registration * PRE-REGISTRATION: Not have ever received prior treatment with LAG-3 blockade * PRE-REGISTRATION: 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 * PRE-REGISTRATION: Absolute Neutrophil Count (ANC) \>= 1,200/mm\^3 * PRE-REGISTRATION: Platelet count \>= 100,000/mm\^3 * PRE-REGISTRATION: Hemoglobin \>= 8 g/dL * PRE-REGISTRATION: Creatinine =\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation * PRE-REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN * PRE-REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) * PRE-REGISTRATION: For women of childbearing potential only: A negative urine or serum pregnancy test done =\< 14 days prior to pre-registration is required * PRE-REGISTRATION: Not currently requiring hemodialysis * PRE-REGISTRATION: No current or prior history of myocarditis * PRE-REGISTRATION: No grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade * PRE-REGISTRATION: No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease. * PRE-REGISTRATION: Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. * PRE-REGISTRATION: Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. * PRE-REGISTRATION: No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years. * PRE-REGISTRATION: No known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected). * PRE-REGISTRATION: 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. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. * PRE-REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible. * PRE-REGISTRATION: No concurrent antineoplastic therapy. * PRE-REGISTRATION: No current immunosuppressive agents (with the exception of corticosteroids as described below). * PRE-REGISTRATION: No condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * REGISTRATION: Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\< 18 weeks prior to registration. * REGISTRATION: Must have evaluable ctDNA Signatera assay result (i.e., ctDNA\[+\]or ctDNA\[-\]) based on test performed as part of central testing at pre-registration to A032103. Central testing is defined as testing performed as part of the A032103. Local/commercial testing results may not be used for registration to A032103 * Cisplatin-ineligible (or cisplatin-declining) patients with a pT2N0 urothelial cancer on cystectomy or nephroureterectomy or ureterectomy who were pre-registered based on routine standard care ctDNA(+) Signatera testing must have confirmed ctDNA(+) Signatera testing on central testing. If central Signatera testing yields a ctDNA(-) result, these patients are ineligible. NOTE: This is a distinct consideration from patients with ypT2-4 and/or ypN+ urothelial cancer (i.e., patients who had received neoadjuvant cisplatin-based chemotherapy) who are eligible with either ctDNA(+) or ctDNA(-) central Signatera testing * REGISTRATION: All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal nodes less than 15 mm in short axis, or \< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy. * REGISTRATION: No major surgery =\< 3 weeks before registration. * REGISTRATION: No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed * REGISTRATION: No change since registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * Patient must have converted to ctDNA(+) during serial monitoring performed centrally in the setting of the A032103 study * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\[-\] to ctDNA\[+\]). * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * No change in clinical condition and/or laboratory tests that would impact the safety of nivolumab administration in the opinion of the treating investigator * COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+): * =\< 6 weeks from reporting of ctDNA(+) result to site (not from the date sample was drawn).
PROCEDURE: Biospecimen Collection, OTHER: cfDNA or ctDNA Measurement, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, OTHER: Questionnaire Administration, BIOLOGICAL: Relatlimab
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma, Muscle Invasive Ureter Urothelial Carcinoma, Muscle Invasive Urethral Urothelial Carcinoma, Stage II Bladder Urothelial Carcinoma AJCC v6 and v7, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
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Location Contacts
AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Addison Gilbert Hospital Gloucester, Massachusetts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
AnMed Health Cancer Center Anderson, South Carolina Site Public Contact - (rhonda.ballew@anmedhealth.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina
Atrium Health Lincoln/LCI-Lincolnton Lincolnton, North Carolina
Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina
Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina
Atrium Health Union/LCI-Union Monroe, North Carolina
Atrium Health University City/LCI-University Charlotte, North Carolina
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BCCA-Vancouver Cancer Centre Vancouver, British Columbia
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baptist Health Louisville Louisville, Kentucky Site Public Contact - (Cbcresearch@bhsi.com)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Ben Taub General Hospital Houston, Texas
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care Winchester, Massachusetts
Beverly Hospital Beverly, Massachusetts
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Richmond Community Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Francis Medical Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bon Secours Saint Mary's Hospital Richmond, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (protocols@AllianceNCTN.org)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Columbus Oncology and Hematology Associates Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Columbus Oncology and Hematology Associates Inc Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dana-Farber Cancer Institute at Boston Medical Center - Brighton Brighton, Massachusetts
Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Doctors Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Dublin Methodist Hospital Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Duke Cancer Center Cary Cary, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke Cancer Center Raleigh Raleigh, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
Duke University Medical Center Durham, North Carolina
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Johns Creek Hospital Johns Creek, Georgia Site Public Contact - (m.lisa.hwang@emory.edu)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
George Washington University Medical Center Washington D.C., District of Columbia
Glens Falls Hospital Glens Falls, New York
Grady Health System Atlanta, Georgia
Grady Memorial Hospital Atlanta, Georgia
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Hackensack University Medical Center Hackensack, New Jersey
Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut
Hartford Healthcare - Fairfield Fairfield, Connecticut Site Public Contact - (CancerResearchSupport@hhchealth.org)
Hartford Hospital Hartford, Connecticut
HaysMed Hays, Kansas
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Highlands Oncology Group Springdale, Arkansas Site Public Contact - (research@hogonc.com)
Highlands Oncology Group - Fayetteville Fayetteville, Arkansas Site Public Contact - (research@hogonc.com)
Highlands Oncology Group - Rogers Rogers, Arkansas Site Public Contact - (research@hogonc.com)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jefferson Cherry Hill Hospital Cherry Hill, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Jefferson Torresdale Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii Site Public Contact - (shelley.a.clark@kp.org)
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Baldwin Park Baldwin Park, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Franklin Denver, Colorado Site Public Contact - (kristi.m.bronkan@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Lone Tree Lone Tree, Colorado
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Rock Creek Lafayette, Colorado
Kaiser Permanente-Roseville Roseville, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kansas City Veterans Affairs Medical Center Kansas City, Missouri
Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Keck Medicine of USC Koreatown Los Angeles, California
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lahey Hospital and Medical Center Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Medical Center-Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania Site Public Contact - (nctn@pennmedicine.upenn.edu)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lawrence Memorial Hospital Lawrence, Kansas Site Public Contact - (Stephanie.Norris@LMH.ORG)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Levine Cancer Institute - Huntersville Huntersville, North Carolina
Levine Cancer Institute - Rutherford Forest City, North Carolina
Levine Cancer Institute - Union West Matthews, North Carolina
Levine Cancer Institute-Ballantyne Charlotte, North Carolina
Levine Cancer Institute-Gaston Gastonia, North Carolina
Levine Cancer Institute-Rock Hill Rock Hill, South Carolina
Levine Cancer Institute-SouthPark Charlotte, North Carolina
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
London Regional Cancer Program London, Ontario
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Maimonides Medical Center Brooklyn, New York
Malcom Randall Veterans Administration Medical Center Gainesville, Florida Site Public Contact - (trials@cancer.ufl.edu)
Mary Greeley Medical Center Ames, Iowa
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McFarland Clinic - Boone Boone, Iowa
McFarland Clinic - Jefferson Jefferson, Iowa
McFarland Clinic - Marshalltown Marshalltown, Iowa
McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa
McLaren Cancer Institute-Bay City Bay City, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Northern Michigan Petoskey, Michigan Site Public Contact - (ctoadmin@karmanos.org)
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical Center of the Rockies Loveland, Colorado
Medical College of Wisconsin Milwaukee, Wisconsin
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital West Pembroke Pines, Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Miami Cancer Institute Miami, Florida
Michael E DeBakey VA Medical Center Houston, Texas
Midstate Medical Center Meriden, Connecticut
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monmouth Medical Center Southern Campus Lakewood, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Medical Center Miami Beach, Florida Site Public Contact - (yenrique@msmc.com)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northside Hospital Atlanta, Georgia Site Public Contact - (ClinicalTrials@northside.com)
Northside Hospital - Duluth Duluth, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northside Hospital - Gwinnett Lawrenceville, Georgia Site Public Contact - (Clinical.trials@northside.com)
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Oak Brook Oak Brook, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (WI_research_admin@hshs.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Marion General Hospital Marion, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth O'Bleness Hospital Athens, Ohio
OhioHealth Pickerington Methodist Hospital Pickerington, Ohio
OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio
Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa, Oklahoma
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Poudre Valley Hospital Fort Collins, Colorado
Presbyterian Kaseman Hospital Albuquerque, New Mexico Site Public Contact - (WBurman@phs.org)
Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico Site Public Contact - (WBurman@phs.org)
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Greenville Memorial Hospital Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProHealth Waukesha Memorial Hospital Waukesha, Wisconsin
ProMedica Flower Hospital Sylvania, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverside Methodist Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rochester General Hospital Rochester, New York Site Public Contact - (tia.derosa@rochestergeneral.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon Site Public Contact - (mccinfo@mtcancer.org)
Saint Francis Medical Center Cape Girardeau, Missouri Site Public Contact - (sfmc@sfmc.net)
Saint John's Cancer Institute Santa Monica, California
Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Sanford Bismarck Medical Center Bismarck, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org)
Sanford Joe Lueken Cancer Center Bemidji, Minnesota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford Roger Maris Cancer Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey Site Public Contact - (ONCTrialNow@jefferson.edu)
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Solinsky Center for Cancer Care Manchester, New Hampshire
Southern Illinois University School of Medicine Springfield, Illinois
Southern Ocean County Medical Center Manahawkin, New Jersey
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Swedish Covenant Hospital Chicago, Illinois
The Hospital of Central Connecticut New Britain, Connecticut
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The New York Hospital Medical Center of Queens Flushing, New York Site Public Contact - (ctsucontact@westat.com)
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
The West Clinic - Wolf River Germantown, Tennessee Site Public Contact - (afletcher@westclinic.com)
Thomas Jefferson University Hospital Philadelphia, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) (LIBELULA)

Debiopharm International S.A - clinicaltrials@debiopharm.com

PHASE3
NCT06129539
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Inclusion Criteria:

• Diagnosis of central precocious puberty.
• Onset of development of sex characteristics (i.e., breast development in girls or testicular enlargement in boys according to the Tanner method) before the age of 8 years in girls and 9 years in boys.
• Initially, only participants aged (a) 5 to 8 years inclusive (i.e., \<9 years) are eligible. The Sponsor will determine based on the recommendation of the DMC following the interim analysis whether participants aged (b) 2 to 4 years inclusive (i.e., \<5 years) and/or (c) 9 to 10 years inclusive (i.e., \<11 years) may be recruited.
• Participant to receive at least 1 year of gonadotropin-releasing hormone agonist (GnRHa) therapy from study treatment start.
• (a) Pre-treated participants: Start of initial GnRHa therapy no later than 18 months after onset of the first signs of CPP. (b) Treatment-naive participants: Start of Debio 4326 treatment no later than 18 months after onset of the first signs of CPP.
• (a) Pre-treated participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year based on historical values at the initiation of the GnRHa therapy. (b) Treatment-naive participants: Difference between bone age (Greulich and Pyle method) and chronological age of ≥1 year.
• (a) Pre-treated participants: Pubertal-type LH response (LH ≥6 IU/L) following a GnRH/GnRHa stimulation test, or random non-stimulated serum LH \>0.5 IU/L (if considered local standard of care), based on historical values prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Pubertal-type LH response (≥6 IU/L) 30 minutes following a GnRHa \[leuprolide acetate 20 micrograms per kilogram (μg/kg) subcutaneous injection (SC)\] stimulation test before treatment initiation.
• (a) Pre-treated participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 milliliter (mL) (cubic centimeter \[cc\]) for boys, prior to the initiation of GnRHa therapy. (b) Treatment-naive participants: Clinical evidence of puberty, defined as Tanner Staging ≥2 for breast development for girls and testicular volume ≥4 mL (cc) for boys.
Exclusion Criteria:

• Gonadotropin-independent (peripheral) precocious puberty: gonadotropin-independent gonadal or adrenal sex steroid secretion.
• (a) Pre-treated participants: Non-progressing, isolated premature thelarche prior to the initial GnRHa therapy. (b) Treatment-naive participants: Non-progressing, isolated premature thelarche.
• Presence of an unstable intracranial tumor or an intracranial tumor potentially requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible.
• Any other condition or chronic illness possibly interfering with growth (e.g., renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
• Other than GnRHa therapy in pre-treated participants, any ongoing treatment with a potential effect on serum levels of gonadotropins or sex steroids, or possibly interfering with growth, opioids, central nervous system \[CNS\] stimulants).
• Prior or current therapy with medroxyprogesterone acetate, growth hormone, or Insulin-like growth factor-1 (IGF-1).
• Diagnosis of short stature, i.e., more than 2.25 standard deviations (SD) below the mean height-for-age.
• Known history of seizures, epilepsy, and/or central nervous system disorders that may have been associated with seizures or convulsions.
• Prior (within 2 months of study treatment start) or current use of medications that have been associated with seizures or convulsions.
• Use of anticoagulants (heparin or coumarin derivatives). Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
DRUG: Debio 4326
Central Precocious Puberty
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Study Locations

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Location Contacts
Akron Children's Hospital Akron, Ohio
Ann and Robert H.Lurie Children's Hospital of Chicago Chicago, Illinois
Atlanta Diabetes Associates Atlanta, Georgia
CETI - Centro de Estudos em Terapias Inovadoras Ltda Curitiba,
CPCLIN - Centro de Pesquisas Clínicas Ltda. São Paulo,
CPQuali Pesquisa Clinica São Paulo,
Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada Buenos Aires,
Centro de Investigaciones Medicas Mar del Plata Mar del Plata,
Children's Hospital at Montefiore The Bronx, New York
Christus Latam Hub Center of Excellence and Innovation S C Monterrey,
Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L San Miguel de Tucumán,
Clínica de Endocrinologia e Metabologia Ltda Lago Sul,
ENDOMET Antofagasta,
Fundação Faculdade Regional de Medicina de São José do Rio Preto Sao Jose Rio Preto,
Hospital Angeles Puebla Puebla City,
Hospital Clinico San Borja Arriaran (HCSBA) Santiago,
Hospital Da Criança de Brasília Jose Alencar Brasília,
Hospital Universitario Walter Cantidio Fortaleza,
Icahn School of Medicine at Mount Sinai New York, New York
Indiana University/Riley Hospital for Children Indianapolis, Indiana
Instituto de Investigaciones Metabolicas (IDIM) Buenos Aires,
Integral Pesquisa e Ensino Votuporanga,
Investigational Drug Service, The Children's Hospital of Philadelphia Philadelphia, Pennsylvania
Irmandade Santa Casa de São Paulo São Paulo,
Nemours Children's Health Pensacola, Florida
Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS Porto Alegre,
Prisma Health Pediatric Endocrinology Columbia, South Carolina
Rady Children's Hospital - San Diego San Diego, California
Research Institute of Dallas Dallas, Texas
TMC HealthCare Tucson, Arizona
Texas Children's Hospital Houston, Texas
University of California San Francisco-Benioff Children's Hospital San Francisco, California
University of Michigan Ann Arbor, Michigan
University of Texas Southwestern Medical Center Dallas, Texas
Virginia Commonwealth University Health System Richmond, Virginia
Washington University St Louis, Missouri
Wolfson's Children's Hospital Jacksonville, Florida