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Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Takeda Contact - medinfoUS@takeda.com

NCT05677971
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Inclusion criteria: * The participant must have a diagnosis of the Z allele homozygotes (PiZZ) genotype AATD. PiZZ diagnosis from source verifiable medical records is permitted. Otherwise, participants must undergo PiZZ confirmatory testing (genotyping for PiS and PiZ alleles) at screening. PiMZ or PiSZ genotypes are not permitted. * The participant, of any sex, is aged 18 to 75 years, inclusive. * The participant's liver biopsy core sample collected should meet the requirements of the protocol. * The participant has evidence of METAVIR stage F2, F3, or F4 liver fibrosis, evaluated by a centrally read baseline liver biopsy during the screening period; or confirmed as meeting all the entry criteria by central reading of a previous biopsy conducted within 6 months before the estimated enrollment date using an adequate liver biopsy and slides as defined in the study laboratory manual. * The participant has a pulmonary status meeting the protocol's requirements. * It must be confirmed that the participant does not have HCC. Participants will be screened for HCC with alpha-fetoprotein (AFP) and abdominal ultrasound. If the participant has any of the following, they will be required to have contrast-enhanced CT or MRI imaging to exclude HCC before randomization. * An adult participant must have a body mass index (BMI) greater than or equal to (\>=) 18.0 kilograms per meter square (kg\^m2). * The participant is a nonsmoker for at least 6 months before screening. Exclusion Criteria * The participant has a history of liver decompensating events (overt hepatic encephalopathy \[West Haven Grade \>=2\] documented by a physician or healthcare professional, clinically significant ascites, spontaneous bacterial peritonitis, GI bleeding from varices, hepatopulmonary syndrome, hepatorenal syndrome, portal pulmonary hypertension, or bleeding portal hypertensive gastropathy). * The participant has a history of the presence of medium or large varices or varices with red wale signs based on a previous esophagogastroduodenoscopy (EGD) within 6 months before the estimated enrollment date. For certain participants, an EGD will be required at screening if there is no EGD available within 6 months before the estimated enrollment date. Presence of small varices with no red wale signs on EGD and no history of bleeding will be acceptable for study eligibility. * The participant has evidence of chronic liver disease attributable to other diseases, including viral hepatitis B or C, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, alcoholic hepatitis, hemochromatosis, liver cancer, history of biliary diversion, or autoimmune hepatitis. * The participant has alanine transaminase (ALT) or aspartate transaminase (AST) levels \>250 units per liter (U/L). * The participant has a platelet count \<60,000 per cubic millimeter (mm\^3) (\<60 × 10\^9 per liter \[10\^9/L\]). * The participant has albumin \<=2.8 gram per deciliter (g/dL) (28 grams per liter \[g/L\]). * The participant has international normalized ratio (INR) \>=1.7. * The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals. * The participant has a history of drug abuse (such as cocaine, phencyclidine) within 1 year before the screening visit or has a positive urine drug screen at screening. * The participant has previously been treated with fazirsiran or any other RNAi for AATD-LD. * The participant has portal vein thrombosis. * The participant has a prior transjugular portosystemic shunt procedure. * The participant has a history of malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer. Participants with other curatively treated malignancies who have no evidence of metastatic disease and a greater than 1-year disease-free interval may be entered after approval by the medical monitor.
DRUG: Fazirsiran Injection, OTHER: Placebo
Alpha1-Antitrypsin Deficiency
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Study Locations

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Location Contacts
Addenbrooke's Hospital Cambridge, Site Contact - (Bill.griffiths@nhs.net)
Amsterdam UMC - VUmc - De Boelelaan Amsterdam,
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Site Contact - (vincenza.calvaruso@unipa.it)
Baylor College of Medicine Medical Center Houston, Texas Site Contact - (george.cholankeril@bcm.edu)
Beaumont Hospital Dublin, Co Dublin Site Contact - (gmcelvaney@rcsi.ie)
Bon Secours St. Mary's Hospital Richmond, Virginia Site Contact - (mitchell_shiffman@bshsi.org)
Boston Medical Center Boston, Massachusetts Site Contact - (amohanty@bu.edu)
Brigham and Womens Hospital Boston, Massachusetts Site Contact - (NHASHEMI@BWH.HARVARD.EDU)
CCA Hospital Braga Braga, Site Contact - (crolanda@med.uminho.pt)
Cardinal Glennon Children's Hospital St Louis, Missouri Site Contact - (jeffrey.teckman@slucare.ssmhealth.com)
Centre Francois Magendie Pessac, Site Contact - (maeva.zysman@chu-bordeaux.fr)
Centro Hospitalar do Porto Porto, Site Contact - (luisazevedomaia@hotmail.com)
Charité - Campus Virchow-Klinikum-Ostring 1 Berlin, Site Contact - (frank.tacke@charite.de)
Children's Healthcare of Atlanta Atlanta, Georgia
Columbia University Irving Medical Center New York, New York Site Contact - (mpg2124@cumc.columbia.edu)
Derriford Hospital Plymouth, Site Contact - (ashwin.dhanda@nhs.net)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan, Site Contact - (luca.valenti@policlinico.mi.it)
Fondazione IRCCS Policlinico San Matteo di Pavia Pavia, Site Contact - (corsico@unipv.it)
GI Research Institute Vancouver, Site Contact - (hinnih@gmail.com)
Gastroenterology & Liver Institute Escondido, California
Hannover Medical School Hanover, Site Contact - (wedemeyer.heiner@mh-hannover.de)
Henry Ford Medical Center - Columbus Detroit, Michigan Site Contact - (sgordon3@hfhs.org)
Hopital Beaujon Clichy, Site Contact - (kathleenlourdes.milord@aphp.fr)
Hopital PONTCHAILLOU CHU de Rennes Rennes, Site Contact - (edouard.bardou-jacquet@chu-rennes.fr)
Hopital Paul Brousse Val-de-Marne, Site Contact - (audrey.coilly@aphp.fr)
Hopital de la Croix Rousse Lyon, Site Contact - (teresa.antonini@chu-lyon.fr)
Hospital Nélio Mendonça Funchal, Site Contact - (magnovitorp@gmail.com)
Hospital Purpan Toulouse, Site Contact - (alric.l@chu-toulouse.fr)
Hospital Sírio-Libanês São Paulo, São Paulo Site Contact - (gildaporta@gmail.com)
Hospital Universitario Marqués de Valdecilla Santander, Site Contact - (alvaro.diaz@scsalud.es)
Hospital Universitario Vall d'Hebron - PPDS Barcelona, Site Contact - (monica.pons@vhir.org)
Hospital Universitario Virgen de la Victoria Málaga, Site Contact - (andrade@uma.es)
Hospital Universitario Virgen del Rocio - PPDS Seville, Site Contact - (mromerogomez@us.es)
Hospital de Base do Distrito Federal Brasília, Site Contact - (mendesliliana2@gmail.com)
Hvidovre Hospital Hvidovre, Site Contact - (elias.badal.rashu@regionh.dk)
ID Clinic Arkadiusz Pisula Mysłowice,
IRCCS Istituto Clinico Humanitas Rozzano, Site Contact - (alessio.aghemo@humanitasresearch.it)
Indiana University School of Medicine - Indianapolis Indianapolis, Indiana Site Contact - (rvuppala@iu.edu; mandcruz@iu.edu)
Inselspital Bern Bern, Site Contact - (studien.hepatologie@insel.ch)
Inspiration Research Limited Toronto, Ontario Site Contact - (kchapman@inspirationresearch.ca)
Institut klinicke a experimentalni mediciny Prague, Site Contact - (jan.sperl@ikem.cz)
Karolinska Universitetssjukhuset Huddinge Huddinge, Site Contact - (staffan.wahlin@ki.se)
King's College Hospital London, Site Contact - (aftab.ala1@nhs.net)
Klinikum Klagenfurt am Wörthersee Klagenfurt, Carinthia Site Contact - (markus@peck.at)
LKH-Universitätsklinikum Graz Graz, Site Contact - (martin.wagner@medunigraz.at)
Leiden University Medical Center Leiden, Site Contact - (e.f.a.van_t_wout@lumc.nl)
Mayo Clinic Rochester, Minnesota Site Contact - (vargas.hugo@mayo.edu)
Mayo Clinic - PPDS Rochester, Minnesota Site Contact - (malhi.harmeet@mayo.edu)
Medical University of South Carolina Charleston, South Carolina Site Contact - (strangec@musc.edu)
Medizinische Universitat Innsbruck Innsbruck, Tyrol Site Contact - (heinz.zoller@i-med.ac.at; hepa-studyteam@i-med.ac.at)
Medizinische Universität Wien (Medical University of Vienna) Vienna, Site Contact - (mattias.mandorfer@meduniwien.ac.at)
Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN New York, New York
NYU Langone Health New York, New York Site Contact - (viviana.figueroadiaz@nyulangone.org)
Ochsner Medical Center New Orleans, Louisiana Site Contact - (gtherapondos@ochsner.org)
Peak Gastroenterology Associates, PC Colorado Springs, Colorado Site Contact - (bpatel@peakgastro.com)
Penn State Health Milton S. Hershey Medical Center Hershey, Pennsylvania Site Contact - (tcraig@pennstatehealth.psu.edu)
Queen Elizabeth II Health Sciences Center Halifax, Nova Scotia Site Contact - (julie.zhu@nshealth.ca)
Queen's Medical Centre Nottingham,
Royal Adelaide Hospital Adelaide,
Royal Free Hospital London, Site Contact - (aileen.marshall@nhs.net)
Royal Infirmary of Edinburgh Edinburgh, Scotland Site Contact - (michael.williams@nhslothian.scot.nhs.uk)
Schiff Center for Liver Diseases/University of Miami Miami, Florida Site Contact - (eschiff@med.miami.edu)
St Vincents Hospital Melbourne - PPDS Fitzroy, Victoria Site Contact - (matthew.conron@svha.org.au)
St. Joseph's Hospital and Medical Center Phoenix, Arizona Site Contact - (nilofar.najafian@commonspirit.org)
Stanford University Stanford, California Site Contact - (pkwo@stanford.edu)
Temple University Hospital Philadelphia, Pennsylvania Site Contact - (yedidya.saiman@tuhs.temple.edu)
Texoma Liver Center Denison, Texas Site Contact - (h.elgouhari@somacinicaltrials.com)
The Texas Liver Institute San Antonio, Texas Site Contact - (lawitz@txliver.com)
UCLA Pulmonary and Critical Care Los Angeles, California Site Contact - (ibarjaktarevic@mednet.ucla.edu)
UZ Antwerpen Edegem, Site Contact - (sven.francque@uza.be)
UZ Leuven Leuven, Site Contact - (jef.verbeek@uzleuven.be)
Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu São Paulo, Site Contact - (fgromeiro@gmail.com)
Universitetssjukhuset i Linköping Linköping, Site Contact - (mattias.ekstedt@liu.se)
University Hospitals Cleveland Medical Center Cleveland, Ohio Site Contact - (seth.sclair@uhhospitals.org)
University of Alabama at Birmingham Birmingham, Alabama Site Contact - (grayme@uab.edu)
University of Arizona Thomas D. Boyer Liver Institute Tucson, Arizona
University of California Benioff Children's Hospital San Francisco, California Site Contact - (PROSENTH@ucsf.edu)
University of California San Diego, Altman Clinical and Translational Institute La Jolla, California Site Contact - (roloomba@health.ucsd.edu)
University of Florida Gainesville, Florida Site Contact - (briana.foerman@medicine.ufl.edu)
University of Iowa Hospitals and Clinics Iowa City, Iowa Site Contact - (tomohiro-tanaka@uiowa.edu)
University of Maryland Medical Center Baltimore, Maryland Site Contact - (kshetty@som.umaryland.edu)
University of Michigan Hospital Ann Arbor, Michigan Site Contact - (rfontana@med.umich.edu)
Universitätsklinikum Schleswig-Holstein - Campus Kiel Kiel, Site Contact - (rainer.guenther@uksh.de)
Universitätsklinikum Tübingen Tübingen, Site Contact - (christoph.berg@med.uni-tuebingen.de)
Universitätsklinikum der RWTH Aachen Aachen, Site Contact - (pstrnad@ukaachen.de)
VCU Medical Center North Hospital Richmond, Virginia Site Contact - (amon.asgharpour@vcuhealth.org)
Vanderbilt University Medical Center Nashville, Tennessee Site Contact - (roman.perri@vumc.org)
WIP Warsaw IBD Point Profesor Kierkus Warsaw, Site Contact - (j.kierkus@wip.waw.pl)
Washington University School of Medicine in St. Louis St Louis, Missouri Site Contact - (smeduchenry@wustl.edu)

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

ctrrecruit@vcu.edu

NCT05382338
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Inclusion Criteria:
* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment * PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis * Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening * PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI) * PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery * PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031. * Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol * PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031 * PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1 * Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection * PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 * Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment * Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative * Average-risk cohort * Clinico-pathologic criteria: * M0 disease * No diffuse anaplastic histology AND * Molecular criteria: * SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss * Group 3, MYC normal, no isochromosome 17q * Group 4, no chromosome 11 loss * Low-risk features cohort * Clinico-pathologic criteria: * M0 disease * No diffuse anaplastic histology AND * Molecular criteria: * Group 4, chromosome 11 loss * Patients must have negative lumbar CSF cytology * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively * Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed * Patients must weigh \> 10 kg * Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0) * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment) * Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment) * Hemoglobin \>= 8.0 g/dL (may receive red blood cell count \[RBC\] transfusions) (within 7 days prior to enrollment) * A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows: * 4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female) * 6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female) * 10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female) * 13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female) * \>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). 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) * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment * Auditory function defined as: * Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment * 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 with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible * Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids * Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril) * Pregnancy and Breastfeeding: * 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 their study participation
PROCEDURE: Audiometric Test, PROCEDURE: Auditory Brainstem Response, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, DRUG: Cyclophosphamide, DRUG: Lomustine, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Sodium Thiosulfate, OTHER: Survey Administration, DRUG: Vincristine
Childhood Medulloblastoma
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Study Locations

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Location Contacts
Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
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 New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama
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 - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Connecticut Children's Medical Center Hartford, Connecticut
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)
Dana-Farber Cancer Institute Boston, Massachusetts
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)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
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 - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Loma Linda University Medical Center Loma Linda, California
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
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)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.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
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Phoenix Childrens Hospital Phoenix, Arizona
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)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
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 Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
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
Southern Illinois University School of Medicine Springfield, Illinois
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
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 Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
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 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 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)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment (ELFINITY)

Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com

NCT06447168
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Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol. * Participant with PBC diagnosis. * Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor. * If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance. * Participant with known hypersensitivity to the product or to any of its excipients. * Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Primary Biliary Cholangitis
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Study Locations

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(G.I.R.I) GI Research Institute Foundation Vancouver,
A. Gemelli University Hospital, Catholic University of the Sacred Heart Roma,
ASST Grande Ospedale Metropolitano Niguarda Milan,
ASST-Ospedale Papa Giovanni XXIII Bergamo,
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board Aberdeen,
Baylor College of Medicine - Advanced Liver Therapies Houston, Texas
Belfast Health and Social Care Trust - Royal Victoria Hospital Belfast,
Beth Israel Deaconess Medical Center, Liver Research Center Boston, Massachusetts
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond Richmond, Virginia
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation Bradford,
Cedars-Sinai Medical Center Los Angeles, California
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) Montreal,
Charité Universitätsmedizin Berlin Berlin,
Clemenceau Medical Center Hospital Dubai,
Cleveland Clinic Foundation Cleveland, Ohio
Complexo Hospitalario Universitario de Pontevedra Pontevedra,
DRK Kliniken Berlin Mitte Berlin,
Fondazione Policlinico Universitario Campus Bio-Medico Roma,
Gastro health & Nutrition Katy, Texas
Gastroenterologsiche Studiengesellschaft Herne Herne,
General Hospital of Athens Laiko Athens,
Hospital Clinic de Barcelona (Hospital Clinic i Provincial) Barcelona,
Hospital General Universitario Gregorio Maranon (HGUGM) Madrid,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital de Torrecardenas Almería,
Hospital of the Merciful Brothers Trier Trier,
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust Hull,
Instituto De Investigacion Marques De Valdecilla (IDIVAL) Santander,
Intermountain Medical Center Murray, Utah
Ippokratio General Hospital of Thessaloniki Thessaloniki,
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust Oxford,
King's College Hospital NHS Foundation Trust London,
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt,
Liver Center of Texas Dallas, Texas
London Health Sciences Centre (LHSC) - University Hospital London,
Medical University Innsbruck Innsbruck,
Medical University of South Carolina (MUSC) Charleston, South Carolina
Mediclinic Airport Road Hospital Dubai,
Medizinische Universitaetsklinik Graz Graz,
Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset, New York
Ordensklinikum Linz GmbH Barmherzige Schwestern Linz,
Ospedale Garibaldi Nesima Catania,
Ospedale Maggiore Della Carita Novara,
Pusan National University Hospital (PNUH) Busan,
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust Birmingham,
Queen's Medical Centre - Nottingham University Hospitals NHS Trust Nottingham,
Rashid Hospital Dubai,
Royal Prince Alfred Hospital Camperdown,
Samsung Medical Center Seoul,
Schiff Center for Liver Diseases - University of Miami Miami, Florida
Seoul National University Bundang Hospital (SNUBH) Seoul,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Sheikh Shakhbout Medical City Dubai,
South Denver Gastroenterology,P.C. Englewood, Colorado
Southern California Research Center Coronado, California
St Vincent'S Hospital Fitzroy,
Studiengesellschaft BSF Halle,
Texas Digestive Specialists McAllen, Texas
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle,
The Ottawa Hospital - General Campus Ottawa,
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill, North Carolina
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) Florence,
Universitaet des Saarlandes Homburg,
Universitaetsklinikum Leipzig Leipzig,
University General Hospital of Larissa Larissa,
University General Hospital of Patras Pátrai,
University Hospital of Heraklion Heraklion,
University of Calgary Calgary,
University of California Davis Medical Center Sacramento, California
Velocity Clinical Research Seattle, Washington
Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia
Virtua Center for Liver Disease - Cherry Hill Cherry Hill, New Jersey
Yale University School of Medicine New Haven, Connecticut

A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis (ELFIDENCE)

Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com

NCT06016842
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Inclusion Criteria : * Male or female participants must be ≥18 years of age at the time of signing the informed consent. * Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC) * Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B. * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria : * History or presence of other concomitant liver disease including but not limited to: * i) Primary sclerosing cholangitis (PSC). * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA. * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative. * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented). * v) Alcohol-associated liver disease (ALD). * vi) Nonalcoholic steatohepatitis (NASH). * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency. * History or presence of clinically significant hepatic decompensation, including: * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \>12 due to hepatic impairment. * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol. * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1. * Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2. * Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease). * Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled. * Non-hepatic medical conditions that may diminish life expectancy to \<2 years, including known cancers. * History of hepatocellular carcinoma. * Alpha-fetoprotein (AFP) \>20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma. * Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin). * Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period. i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent. * Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \>480 msec would be exclusionary. * Total bilirubin (TB) \>5x ULN * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5x ULN at SV1 * Creatinine phosphokinase (CPK) \>2x ULN. * Platelet count \<50,000/μL * International normalised ratio (INR) \>1.8 in the absence of anticoagulant therapy. * Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1. * Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury). * For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding. * Participants unwilling or unable to be abstinent from alcohol during the study. * History of alcohol abuse, or other substance abuse within 1 year prior to SV1. * Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s). * Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain. * Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study. * Alkaline phosphatase (ALP) ≥10x ULN. * Albumin \<2.8 g/dL due to impaired hepatic function.
DRUG: Elafibranor, OTHER: Matched 80 mg placebo
Primary Biliary Cholangitis (PBC)
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Study Locations

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Location Contacts
Agios Savvas Regional Cancer Hospital Athens,
Algemeen Ziekenhuis Delta Roeselare,
American Research Corporation San Antonio, Texas
American Research Corporation at the Texas Liver Institute San Antonio, Texas
Arizona Liver Health Tucson, Arizona
Arkansas Diagnostic Center, PA Little Rock, Arkansas
Artroscan Ostrava,
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo,
Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia Padova,
Azienda Ospedaliero Universitaria Federico II di Napoli Naples,
Azienda Ospedaliero Universitaria Modena Modena,
Azienda Ospedaliero Universitaria Pisana Pisa,
Baylor Scott & White All Saints Medical Center - Forth Worth Fort Worth, Texas
Bispebjerg Hospital Copenhagen,
Bolanos Clinical Research Pembroke Pines, Florida
Bon Secours St. Mary's Hospital of Richmond, Inc Richmond, Virginia
CHA Bundang Medical Center, CHA University Seongnam-si,
CHU Poitiers Poitiers,
CHU de Nice, Hopital de l'Archet Nice,
Canterbury District Health Board Christchurch,
Cedars-Sinai Medical Center Los Angeles, California
Central Hospital of Northern Pest - Military Hospital Budapest,
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille,
Centro Medico Cedid - Centro de Diagnostico Digestivo Viña del Mar,
Centro Medico Colon Córdoba,
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM) Santiago,
Centro de Investigacion Clinica y Medicina Traslacional Guadalajara,
Centro de Investigacion Medico Biologica y Terapia Avanzada Jalisco,
Centro de Investigacion y Gastroenterologia SC Mexico City,
Centrul Pentru Studiul Metabolismului Bucharest,
Centrum Medyczne Medyk Sp. z o.o. Sp. K. Rzeszów,
Chiang Mai University Chiang Mai,
Chung-Ang University Hospital Seoul,
Clinica Universidad Navarra-Sede Madrid Madrid,
Clinique Pasteur Toulouse,
Cluj County Clinical Emergency Hospital Cluj-Napoca,
DIM Centro Medico Buenos Aires,
Diagnostic-Consultative Center Aleksandrovska EOOD Sofia,
Enroll SpA Santiago,
Fakultna nemocnica Nitra Nitra,
Fondazione I.R.C.C.S. Policlinico San Matteo Pavia,
Footscray Hospital, Western Health Footscray,
Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L Buenos Aires,
FutureMeds Warszawa Centrum Warsaw,
FutureMeds sp. z o. o Wroclaw,
Galilee Medical Center Nahariya,
Galilee Medical Center, ZIV Medical Center Nahariya,
Gastro health & Nutrition Katy, Texas
GastroIntestinal Biosciences Los Angeles, California
Gastroenterological Centre Thalion Bratislava,
Gastroenterology Center of the Midsouth Cordova, Tennessee
Gastromedica Srl Iași,
GeneIppokratio General Hospital of Thessaloniki Thessaloniki,
General Hospital of Athens Laiko Athens,
General Oncological Hospital of Kifisia Oi Agioi Anargyroi Athens,
Gent University Hospital Ghent,
Hadassah University Hospital (HUH) - Ein-Kerem Jerusalem,
Hallym University Kangnam Sacred Heart Hospital Seoul,
Hanyang University Seoul Hospital Seoul,
Hepato-Gastroenterologie HK, s.r.o. Hradec Králové,
Hopital Paul-Brousse - APHP Villejuif,
Hopital Pitie-Salpetriere - APHP Paris,
Hopital Saint Joseph - Marseille Marseille,
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse Lyon,
Hospitais da Universidade de Coimbra (H.U.C) - Universidade de Coimbra Coimbra, Praceta Mota Pinto
Hospital Angeles Valle Oriente Monterrey,
Hospital Britanico de Buenos Aires CABA, Buenos Aires
Hospital Clinic i Provincial de Barcelona Barcelona,
Hospital Clinico de la Pontificia Universidad Catolica de Chile Santiago,
Hospital Dr. Nelio Mendonca Funchal,
Hospital El Cruce San Juan Bautista,
Hospital Espanol De Mendoza Godoy Cruz, Mendoza Province
Hospital General Universitario Gregorio Maranon (HGUGM) Madrid,
Hospital Henri Mondor Créteil,
Hospital Queen Elizabeth II Kota Kinabalu,
Hospital Sultanah Aminah Johor Bahru,
Hospital Universitario Austral Pilar,
Hospital Universitario La Paz Madrid,
Hospital Universitario Miguel Servet Zaragoza,
Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda,
Hospital Universitario Rio Hortega Valladolid,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital Universitario Virgen de la Victoria Málaga,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario y Politécnico La Fe Valencia,
Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo São Paulo,
Hospital de Base - Centro Integrado de Pesquisa ( CIP ) São Paulo,
Hospital de Clinicas de Porto Alegre (HCPA) Porto Alegre,
Hospital de Montecelo Pontevedra,
Hospital of Lithuanian University of Health Sciences Kaunas Kaunas,
Houston Methodist Cancer Center Houston, Texas
Huron Gastroenterology Associates - Center for Digestive Care Ypsilanti, Michigan
Impact Research Tx Waco, Texas
Inha University Hospital Incheon,
Inje University Ilsan Paik Hospital Goyang-si,
Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli Sabadell,
Institute for Clinical and Experimental Medicine - IKEM Prague,
Institute of Gastroenterology and Liver Diseases - Soroka University Medical Center Beersheba,
Instituto D'Or de Pesquisa e Ensino - Hospital Aliança Salvador,
International Center for Research Tampa, Florida
Keimyung University Dongsan Hospital Daegu,
Kenezy County Hospital Debrecen,
Korea University Ansan Hospital Gyeonggi-do,
Korea University Guro Hospital Seoul, Guro-gu
Krajská nemocnice Liberec Liberec,
Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds Krakow,
Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds Małogoskie,
Kyungpook National University Hospital (KNUH) Junggu,
Liver Associates of Texas Houston, Texas
Liver Center of Texas Dallas, Texas
Louisiana Research Center, LLC Shreveport, Louisiana
Mayo Clinic Rochester, Minnesota
Medical Care & Research Yucatán,
Medical University of South Carolina Charleston, South Carolina
Medrise Sp. z o.o. Lublin,
Medstar Georgetown Transplant Institute University Hospital (MGUH) Columbia, Washington
Methodist Transplant Physicians Dallas, Texas
Monash University - Monash Health -Monash Medical Centre Melbourne,
NUPEC Cardio Belo Horizonte,
NYU Langone Gastroenterology and Hepatology Associates New York, New York
NZOZ Twoje Zdrowie EL Sp. z o.o. Elblag,
Nepean Clinical School Kingswood,
Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera Sosnowiec,
Nzoz Centrum BadanKlinicznych Wroclaw,
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ, Uniwersytecki Szpital Kliniczny im. Barlickiego w Lodzi Lodz,
Ospedale San Gerardo Monza,
Ospedale casa sollievo della sofferenza San Giovanni Rotondo,
Peak Gastroenterology Associates Colorado Springs, Colorado
PlanetMed Sp. z o.o. Wroclaw,
Prince of Songkla University (PSU) - Songklanagarind Hospital Hat Yai,
Pusan National University Hospital (PNUH) Busan,
Rabin Medical Center - Beilinson Hospital - Liver Institute Petah Tikva,
Rambam Health Care Campus (RHCC) Haifa,
Research Site S.R.O. Pilsen,
Rocky Mountain Gastroenterology Littleton, Colorado
Rush University Medical Center - University Cardiovascular Surgeons Dallas, Texas
Samsung Medical Center Seoul,
Sana S.R.L Bucharest,
Seoul National University Bundang Hospital (SNUBH) Seoul,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
South Denver Gastroenterology, P.C. Englewood, Colorado
Southern California Research Center Coronado, California
Southwest Gastroenterology Associates, PC (SWGA) Albuquerque, New Mexico
Spital Clinic Dr I Cantacuzino Bucharest,
Srinagarind Hospital - Khon Kaen University Khon Kaen,
St George Hospital Sydney,
Sunshine Coast University Hospital Birtinya,
Szegedi Tudomanyegyetem AOK, I. sz Belgyogyaszati Klinika Szeged,
Szpital Uniwersytecki w Krakowie Krakow,
Texas Clinical Research Institute Arlington, Texas
The Catholic University of Korea Daejeon St.Mary's Hospital Daejeon,
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul,
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul,
The Catholic University of Korea, Uijeongbu St. Mary's Hospital Uijeongbu-si,
Tokuda Hospital, Dept. of Internal Medicine Sofia,
Unidade Local de Saúde de Trás-os-Montes e Alto Douro, E. P. E Vila Real,
Universidad De Los Andes Las Condes,
Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB) São Paulo,
Universidade Federal de Goias Goiânia,
Universitair Ziekenhuis Antwerpen Edegem,
University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI) Toronto,
University Hospital City Clinic Cancer Center Sofia,
University Of Miami School Of Medicine, Center For Liver Diseases Miami, Florida
University Physicians and Surgeons Inc, dba Marshall Health Huntington, West Virginia
University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR) Edmonton,
University of California Davis Medical Center Sacramento, California
University of California Los Angeles Los Angeles, California
University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile) Santiago,
University of Colorado Aurora, Colorado
University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic Kansas City, Kansas
University of Malaya Medical Centre Kuala Lumpur,
University of Michigan Health System Ann Arbor, Michigan
University of Pittsburgh Pittsburgh, Pennsylvania
University of Texas Southwestern Medical Center at Dallas Dallas, Texas
University of Virginia Medical Center Charlottesville, Virginia
Univerzitna nemocnica L. Pasteura Kosice Košice,
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego Katowice,
Velocity Clinical Research at Liver Institute Northwest Seattle, Washington
Vilnius University Hospital Santaros Klinikos Vilnius,
Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia
Waikato Hospital Hamilton,
Westmead Hospital Westmead,
Ziekenhuis Oost-Limburg Genk,
hospital Italiano de Buenos Aires CABA, Buenos Aires

Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

ctrrecruit@vcu.edu

NCT05432804
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Inclusion Criteria:
* Patients must have histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) that has undergone resection or biopsy upon first recurrence. Recurrence at site of prior involvement is defined by histopathological evidence of viable neoplastic cells associated with any of the following: mitotic activity, increased proliferation rate, micro-endothelial proliferation, or pseudo-palisading necrosis * Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \>= 2 axial slices * Patients must have received first-line treatment of temozolomide plus radiotherapy * Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease * Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \< 18 years of age, children are excluded from this study * Karnofsky performance status \>= 60% (Eastern Cooperative Oncology Group \[ECOG\] =\< 2) * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Hemoglobin \>= 10 g/dL * Total bilirubin =\< 2 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 3 x institutional ULN * 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 * 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 * The effects of selinexor (KPT-330) and temozolomide on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as deoxyribonucleic acid (DNA) alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 180 days after the last dose of temozolomide. 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 prior to the study, for the duration of study participation, and 90 days after completion of study treatment administration * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Exclusion Criteria:
* Patients who have had chemotherapy must have full recovery of organ and marrow function following the nadir of the last chemotherapy cycle * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients who are receiving any other investigational agents * Patients who have previously received bevacizumab * History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or temozolomide * History of hypersensitivity to dacarbazine (DTIC), since both dacarbazine and temozolomide are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC) * Patients with uncontrolled intercurrent illness * Pregnant women are excluded from this study because selinexor (KPT-330) is a selective inhibitor of nuclear export with 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 selinexor (KPT-330), breastfeeding is not allowed for mothers during treatment with selinexor (KPT-330) and for 7 days after the last dose. These potential risks may also apply to other agents used in this study * Hospitalized patients with severe coronavirus disease of 2019 (COVID-19) who are \>= 75 years old, or with a high-risk COVID-GRAM score, or with lactate dehydrogenase (LDH) \> 370 (U/L) AND D-Dimer \> 600 mcg/L FEU should not receive low-dose selinexor (KPT-330) pending additional results
PROCEDURE: Biospecimen Collection, PROCEDURE: Magnetic Resonance Imaging, DRUG: Placebo Administration, DRUG: Selinexor, DRUG: Temozolomide
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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Study Locations

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City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
Cooperman Barnabas Medical Center Livingston, New Jersey
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah
Keck Medicine of USC Koreatown Los Angeles, California
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Los Angeles General Medical Center Los Angeles, California
Mayo Clinic Hospital in Arizona Phoenix, Arizona Alyx B. Porter Umphrey - (porter.alyx@mayo.edu)
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Roswell Park Cancer Institute Buffalo, New York
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers New Jersey Medical School Newark, New Jersey
UC San Diego Moores Cancer Center La Jolla, California Site Public Contact - (cancercto@ucsd.edu)
UCHealth University of Colorado Hospital Aurora, Colorado
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables, Florida
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach, Florida
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
USC / Norris Comprehensive Cancer Center Los Angeles, California
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 Kentucky/Markey Cancer Center Lexington, Kentucky
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 Virginia Cancer Center Charlottesville, Virginia
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)
VCU Massey Comprehensive Cancer Center Richmond, Virginia
Wake Forest University Health Sciences Winston-Salem, North Carolina

A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

Clinical Team - clinicaltrials@deciphera.com

NCT06619561
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Inclusion Criteria:

• Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
• Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
• Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
• Adequate organ and bone marrow functions.
• Participants of reproductive potential agree to follow the contraception requirements.
• Karnofsky Performance Scale (KPS) of ≥60.
Exclusion Criteria:

• Has aGVHD without manifestations of cGVHD.
• Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
• History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence.
• History of malignancy except for:
• Underlying malignancy for which the transplant was performed
• Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
• Malabsorption syndrome or other illness that could affect oral absorption.
DRUG: Vimseltinib
Chronic Graft-Versus-Host Disease (cGVHD)
Allogeneic hematopoietic stem cell transplant (HSCT), Graft-Versus-Host Disease, GVHD, cGVHD, Graft versus host disease, Immune System Diseases, Organizing Pneumonia, Bronchiolitis Obliterans, Bronchiolitis, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive, Lung Diseases, Bronchiolitis Obliterans Syndrome, Graft vs Host Disease, Sclerosis, Fibrosis, Hematopoietic stem cell transplantation, Liver diseases
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AdventHealth Orlando Orlando, Florida
Avera Cancer Institute Sioux Falls, South Dakota
City of Hope National Medical Center Duarte, California
Cleveland Clinic Cleveland, Ohio
Dana-Farber Cancer Institute Boston, Massachusetts
Duke University Hospital Durham, North Carolina
Emory University winship Cancer Institute Atlanta, Georgia
Henry Ford Cancer Institute Detroit, Michigan
Intermountain Health Denver, Colorado
Levine Cancer Institute Charlotte, North Carolina
Moffitt Cancer Center Tampa, Florida
Oncology Hematology Care Clinical Trials, LLC Cincinnati, Ohio
Oregon Health and Science University Portland, Oregon
Ronald Regan UCLA Medical Center Los Angeles, California
St. David's South Austin Medical Center Austin, Texas
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Tristar Bone Marrow Transplant Nashville, Tennessee
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
UT Southwestern Medical Center Dallas, Texas
University of California Irvine Health Orange, California
University of Illinois Medical Center - Hematology & Oncology Chicago, Illinois
University of Kansas Cancer Center-Westwood Westwood, Kansas
University of Kentucky Markey Cancer Center Lexington, Kentucky
Vanderbilt-Ingram Cancer Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia
Washington University School of Medicine - Siteman Cancer Center St Louis, Missouri

Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+

Massey IIT Research Operations - masseyepd@vcu.edu

NCT06846463
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Inclusion Criteria:
* Patients must have a documented pathologic diagnosis of DLBCL at any stage. * Must have documented MYD88 L265P, CD79B, or NOTCH1 truncation mutation or be CD5+ by IHC. * Age ≥18 years on the day of signing the informed consent form. * Patients must have measurable disease on Positron Emission Tomography-Computed Tomography scan (CT/PET) imaging. * Patient must have received no more than one cycle of R-CHOP prior to enrollment. Length of time between first R-CHOP treatment and planned 2nd R-CHOP treatment should vary by no more than 21 days ± 3 days. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. * Adequate bone marrow function as defined by: * Absolute neutrophil count (ANC) ≥1000/mm3, except for patients with bone marrow involvement in which ANC must be ≥500/mm3. * Platelet ≥75,000/mm3, except for patients with bone marrow involvement in which the platelet count must be ≥30,000/mm3. * Hemoglobin ≥7 g/dL, after transfusion if necessary * Adequate organ function defined as: * Creatinine clearance ≥30 mL/min as estimated by the Cockcroft-Gault equation. * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase ≤2.5 × upper limit of normal (ULN). * Serum total bilirubin ≤3 x ULN (except patients with Gilberts syndrome 3g/dl). * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. * Women of childbearing potential and men must agree to use one of the following highly effective forms of birth control during the treatment and for 1 month following completion of study treatment for women and for 1 week following completion of study treatment for men. * combined (estrogen and progestogen containing) hormonal contraception: * oral * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * bilateral tubal occlusion * vasectomized partner * heterosexual abstinence * Patients must not have any known allergies, hypersensitivity or intolerance to corticosteroids or monoclonal antibodies. * Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments.
Exclusion Criteria:
* Patients with high grade B-cell lymphoma with myelocytomatosis oncogene /immunoglobulin heavy-chain (MYC)/IGH and BCL-2 rearrangements. * Patients with brain metastasis. * Patients with peripheral neuropathy CTCAE grade ≥2. * Any uncontrolled or clinically significant cardiovascular disease including the following: * Myocardial infarction within 6 months before screening. * Unstable angina within 3 months before screening. * New York Heart Association class III or IV congestive heart failure. * History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes). * Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer. * History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention. * History of stroke or intracranial hemorrhage within 6 months before first dose of study drug. * Severe or debilitating pulmonary disease in the opinion of the treating investigator. * Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. * Active fungal, bacterial and/or viral infection requiring systemic therapy. * Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs. * Active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows: * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\< 20 IU), and if they are willing to undergo monitoring every 4 weeks for HBV reactivation. * Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable. * Major surgery within 4 weeks of the first dose of study drug. * Pregnant or lactating women. * Left ventricular ejection fraction (LVEF) \<55% on screening echocardiogram. * Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment. * Hypersensitivity to zanubrutinib, rituximab, cyclophosphamide, doxorubicin, vincristine, or prednisone. * Requires ongoing treatment with a strong CYP3A inducer (Table 3). * Concurrent participation in another therapeutic clinical trial. * Active and/or ongoing autoimmune anemia and/or autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura). * Requires ongoing treatment with warfarin or warfarin derivatives.
DRUG: Zanubrutinib
Diffuse Large B-Cell Lymphoma, DLBCL - Diffuse Large B Cell Lymphoma
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Virginia Commonwealth University Richmond, Virginia Massey Heme Malig Team - (MasseyHemMlg@vcu.edu)

Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)

Rubi Reyes-Fuentez - rubi@procyrion.com

NCT05677100
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Inclusion Criteria (Randomized Study): * Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF); * Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \<1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period. * Persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.; * Age \>21 years and able to provide written informed consent; * Negative pregnancy test if patient is of child-bearing potential. Exclusion Criteria (Randomized Study): * Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone; * Active and ongoing hypotension with a systolic blood pressure \<90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<60 mmHg lasting more than 30 minutes at enrollment; * Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment; * An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure; * Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg/dL (≥353.6 µmol/L) at enrollment; * Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome; * Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment; * Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment; * Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device; * Prior heart transplant or likely heart transplantation before the 30- day follow-up visit; * Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit; * Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days; * Confirmed diagnosis of AL amyloidosis; * Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days; * Stroke within 30 days of enrollment; * Severe Bleeding Risk (any of the following):
• Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,
• GI bleeding within 6 months requiring hospitalization and/or transfusion,
• Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,
• Procedure with arterial ilio-femoral access \> 6 FR within 30 days,
• Platelet count \<75,000 cells/mm3,
• Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;
• Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy :
• Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\],
• Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,
• Femoral artery depth inconsistent with use of closure device,
• Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),
• Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,
• Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol); * Participation in any other clinical investigation that is likely to confound study results or affect the study; * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit; * Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit. Inclusion Criteria (Advanced Heart Failure Registry): * Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF). * Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves. * Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated. * Must have evidence of refractoriness to medical management as documented by persistent signs and/or symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours. * Serum creatinine ≥ 2.0 mg/dL AND eGFR ≤ 45 ml/min/1.73m2 at time of enrollment * Age ≥ 21 years and able to provide written informed consent. * Negative pregnancy test if patient is of childbearing potential. Exclusion Criteria (Advanced Heart Failure Registry): * Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \>5 µg/kg/min dopamine OR \>5 µg/kg/min dobutamine OR \>0.375 µg/kg/min milrinone. * Active and ongoing hypotension with a systolic blood pressure \<80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \<55 mmHg lasting more than 30 minutes at enrollment. * Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment. * An estimated PASP of \>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure. * Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg/dL at enrollment. * Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome. * Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment. * Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \> 1000U/L or total Bilirubin \> 5.0mg/dl) at enrollment. * Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device. * Current or previous support with a durable LVAD. * INTERMACS Profile 1 at enrollment. * Currently on mechanical ventilatory support. * Use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days. * Confirmed diagnosis of AL amyloidosis. * Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days. * Stroke within 30 days of enrollment. * Severe Bleeding Risk (any of the following): * Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days. * GI bleeding within 6 months requiring hospitalization and/or transfusion. * Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding. * Procedure with arterial ilio-femoral access \> 6 Fr within 30 days. * Platelet count \<75,000 cells/mm3 . * Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT. * Inability to tolerate anticoagulation therapy for up to 7 days. * Contraindicated Anatomy : * Descending aortic anatomy that would prevent safe placement of the device \[\<18 mm or \>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\]. * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath. * Femoral artery depth inconsistent with use of closure device. * Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification). * Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury. * Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction/removal of the Aortix pump as demonstrated by imaging. * Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol). * Participation in any other clinical investigation that is likely to confound study results or affect the study. * Poor health such that the patient is unable to undergo the Aortix device placement/retrieval and/or unlikely to be able to survive to the 30-day visit. * Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.
DEVICE: Aortix System
Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF, Heart Failure, Systolic, Heart Failure, Diastolic, Heart Failure, With Decompensation, Heart Failure, Congestive
mechanical circulatory support, percutaneous
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AdventHealth Tampa Tampa, Florida
Advocate Aurora - Good Samaritan Downers Grove, Illinois
Advocate IMMC Chicago, Illinois
AnMed Health Anderson, South Carolina
Ascenscion Alexian Brothers Elk Grove Village, Illinois
Ascension Sacred Heart Pensacola, Florida
Ascension via Christi Kansas Wichita, Kansas
Atrium Health Sanger Heart and Vascular Institute Charlotte, North Carolina
Banner--University Medical Center Phoenix Phoenix, Arizona
BayCare Medical/St. Joseph's Hospital Tampa, Florida
Baylor Scott & White Plano, Texas
Baylor Scott & White Plano, Texas
Broward Health Fort Lauderdale, Florida
Cleveland Clinic Florida Weston, Florida
Duke University Medical Center Durham, North Carolina
Emory University Hospital Atlanta, Georgia
Hackensack University Medical Center Hackensack, New Jersey
Henry Ford Detroit, Michigan
HonorHealth Medical Center Scottsdale, Arizona
Intermountain Health Denver, Colorado
Jefferson Abington Hospital Abington, Pennsylvania
Jersey Shore University Medical Center Neptune City, New Jersey
John Muir Health Concord, California
Mayo Clinic - Arizona Phoenix, Arizona Erica Boyd - (boyd.erica@mayo.edu)
Mount Sinai Morningside Manhattan, New York
New York Presbyterian - Brooklyn Methodist Hospital Brooklyn, New York Jhane Phanor - (jhp4004@nyp.org)
Northwell Health (Lenox Hill) New York, New York
Northwell Health (Staten Island) Staten Island, New York
Novant Health New Hanover Regional Medical Center Wilmington, North Carolina
Nuvance Health Poughkeepsie, New York
Nyph/Cumc New York, New York
Oklahoma Cardiovascular Research Group Oklahoma City, Oklahoma
Oregon Health & Sciences University Portland, Oregon
Penn Presbyterian Medical Center Philadelphia, Pennsylvania
Piedmont Healthcare INC. Augusta, Georgia
San Francisco Veterans Administration San Francisco, California
Semmelweis University Budapest, Laura Kosa-Hobor - (hobor.laura@semmelweis.hu)
Tallahassee Research Institute Tallahassee, Florida
Texas Heart Institute Houston, Texas
The Ohio State University Columbus, Ohio
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
University of California San Francisco San Francisco, California
University of Chicago Chicago, Illinois
University of Michigan, Cardiovascular Medicine Ann Arbor, Michigan
University of Mississippi Medical Center Jackson, Mississippi
University of South Florida Tampa, Florida
University of Virginia Charlottesville, Virginia
Virginia Commonwealth University Richmond, Virginia
Wellstar Research Institue Marietta, Georgia
Zuckerberg San Francisco General San Francisco, California

A Phase 2 Study of PTX 100 in Patients With Relapsed/Refractory CTCL

Upaly Bahadure - upaly@ptxtherapeutics.com

NCT06854653
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Inclusion Criteria:

• Adult patient ≥18 years of age at the time of signing the informed consent.
• Patient is capable of giving adequate signed informed consent
• Have a confirmed diagnosis of CTCL with histological confirmation
• Patients must have greater than or equal to Stage Ib disease.
• Has received and failed (or intolerant of) at least 2 prior lines of prior systemic therapy for their disease.
• Has measurable disease defined by at least one of the following, within 28 days prior to start of study treatment: by evaluable by mSWAT or quantifiable by flow cytometry or morphology in blood or measurable by Lugano Criteria.
• On a stable dose of systemic corticosteroid (\< 10 mg prednisone or equivalent) are permitted. Participants on a stable dose of topical corticosteroids are permitted.
• Washout period- must be 2 weeks (4 weeks for monoclonal antibodies) or 5 -half-lives (whichever is longer) since any prior anti-cancer therapy.
• Must be human T-cell lymphotropic virus type 1 (HTLV1) negative.
• Has an ECOG PS of 0 to 2.
• Life expectancy of 3 months or greater
• Has adequate bone marrow function.
• Has adequate hepatic function.
• Has adequate Renal function.
• Has adequate coagulation function.
• Patients with Human Immunodeficiency virus (HIV) must be on established and stable effective anti-retroviral therapy for at least 4 weeks and have an HIV viral load of less than 400 copies/mL.
• Male patients are eligible to participate if they agree to use a highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
• Female patients are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies: -Not a woman of childbearing potential (WOCBP). * OR * A WOCBP who agrees to use a contraceptive method that is highly effective (with a failure rate of \< 1% per year) or be abstinent from heterosexual intercourse as their preferred method and usual lifestyle, beginning the time of informed consent, during the treatment period and for at least 3 months after the last dose of study treatment.
• A WOCBP must have a negative serum pregnancy within 72 hours of the first dose of study treatment.
• Must be willing and able to adhere to the study as judged by the Investigator.
Exclusion Criteria:

• Patients with known central nervous system involvement.
• Patients who require the use of strong inhibitors or inducers of CYP enzymes or transporters (e.g., CYP3A4, 2D6, 2C19) or (P-gp, BCRP, OATP1B1, OATP1B3, OAT1. OAT3, OCT2, MATE1 and MATE2-K). Patients who are receiving these medications at Screening can be enrolled into the trial if they discontinue them for at least 14 days or 5 half-lives, whichever is longer, before they commence PTX-100. An alternative pharmacological treatment should be instituted by the treating clinician based on clinical judgement.
• Significant cardiovascular disease. A history of, or concurrent interstitial lung disease or severely impaired lung function. 5\. Active viral, bacterial, fungal infection or other serious infection requiring ongoing systemic treatment. Routine antimicrobial prophylaxis is permitted. 6\. Medical history of another malignant tumor within the past 5 years. Exceptions are patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ who have undergone curative therapy with no evidence of disease. 7\. On an immunomodulatory drug for concomitant or intercurrent conditions or who have received any of these agents within 4 weeks of baseline. 8\. Patients with active viral (any etiology) hepatitis are excluded. However, patients with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV deoxyribose nucleic acid titer \< 1000 cps/mL or 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of hepatitis C virus infection who have completed curative antiviral treatment and have a viral load below the limit of quantification may be eligible and should be discussed with the Medical Monitor. 9\. A history or current evidence of any condition, laboratory abnormality or other circumstance that might confound the results of the study or interfere with patient participation for the full duration of the study. 10\. Prior allogeneic or autologous hematopoietic transplantation 11. Has a known psychiatric disorder that would interfere with compliance with the requirements of the study. 12\. Is a consumer of illicit or recreational drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence that in the judgment of the Investigator, would interfere with compliance with the requirements of the study.
DRUG: PTX-100
CTCL
Relapsed or refractory Cutaneous T Cell Lymphoma, CTCL, PTX-100, Mycosis Fungoides, Sezary Syndrome, T Cell Lymphoma, Non-Hodgkin Lymphoma, Cutaneous Lymphoma
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CHU de Bordeaux - Hopital Saint André Bordeaux, Bordeaux
City of Hope Comprehensive Cancer Cente Duarte, California
Dana-Farber Cancer Institute Boston, Massachusetts
Epworth Healthcare Richmond, Victoria Ashna Saini - (Ashna.saini@epworth.org.au)
Hopital Lyon Sud Pierre-Bénite,
Hopital Saint Louis Paris,
IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi Bologna, Bologna
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) Milan,
Linear Clinical Research Nedlands, Western Australia
Rochester Skin Lymphoma Medical Group. PLLC Rochester, New York Brian Poligone, MD, PhD - (bpoligone@roclymphoma.com)
Universita degli Studi Di Brescia-Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Brescia, Brescia
University of California Irvine Irvine, California
Virginia Commonwealth University Massey Comprehensive Cancer Cente Richmond, Virginia
Westmead Hospital Westmead,
Yale Cancer Center New Haven, Connecticut

CardiolRx in Recurrent Pericarditis (MAVERIC Phase-3) (MAVERIC)

Andrea B Parker, MSc., PhD - andrea.parker@cardiolrx.com

NCT06708299
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Inclusion Criteria:

• Patients 18 years of age or older
• A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as: * treatment with an IL-1 blocker for at least 12 months, * free of pericarditis recurrence for at least 6 months and this recurrence, if present, must have occurred in the setting of an interruption or tapering of an IL-1 blocker; and * treatment with an unchanged dose and regimen of on an IL-1 blocker for at least 3 months prior to randomization.
• Pericarditis pain les or equal than 2 on the 11-point Numerical Rating Scale (NRS) for at least 7 days prior to randomization (Visit 1, Day 1)
• C-Reactive Protein (CRP) \< 1.0 mg/dL during screening within 7 days prior to randomization (Visit 1, Day 1).
• Patients who have had a vasectomy or who are willing to use double barrier contraception methods with partners of childbearing potential during the conduct of the trial and for 2 months after the last dose of trial therapy.
• Patients of childbearing potential willing to use an acceptable method of contraception starting with trial therapy administration and for a minimum of 2 months after trial completion. Otherwise, these patients must be postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone \[FSH\] ≥ 40 mIU/mL \[or ≥ 40 IU/L\] if less than 2 years postmenopausal) or be surgically sterile. Acceptable birth control methods that result in a failure rate of less than 1 % include oral, intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); using double-barrier contraception methods with their partners; bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Exclusion Criteria:

• Pericarditis recurrence(s) during IL-1 blocker treatment without interruption or tapering of the IL-1 blocker
• Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); systemic autoimmune disease (e.g., systemic lupus erythematosus)
• Primary diagnosis of myocarditis (diagnosis of myopericarditis is accepted)
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min during screening within 7 days prior to randomization (Visit 1, Day 1)
• Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN) or ALT or AST \> 3x ULN plus bilirubin \> 2x ULN during screening within 7 days prior to randomization (Visit 1, Day 1).
• Sepsis, defined as documented bacteremia during screening within 7 days prior to randomization (Visit 1, Day 1) or other untreated or uncontrolled bacterial infection\*
• Prior history of sustained ventricular arrhythmia(s)
• History of diagnosed long QT syndrome
• QTc interval \> 480 msec (biologically female) or \> 470 msec (biologically male) (please refer to Section 9.2.3 for bundle branch block, bifascicular block and paced rhythm correction) or second or third degree atrioventricular (AV) block in a patient without an implanted functioning pacemaker device during screening within 7 days prior to randomization (Visit 1, Day 1)
• Showing suicidal tendency during the last 12 months, as defined by answering "yes" to question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS), administered during screening within 7 days prior to randomization (Visit 1, Day 1)
• Participation in a clinical trial in which an investigational drug or device was administered within 30 days of screening or within 5 half-lives of the previous study drug, whichever is longer
• Inability or unwillingness to give informed consent
• Ongoing drug or alcohol abuse in the opinion of the investigator
• On any cannabinoid during the past month or unwilling to stay abstinent from all cannabis products for the duration of the trial
• Pregnant or breastfeeding
• Current diagnosis of active cancer, with the exception of non-melanoma skin cancer
• Any factor, which would make it unlikely that the patient can comply with the trial procedures
• Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• Has received systemic immunomodulatory agents as below prior to randomization:
• Methotrexate (within 2 weeks)
• Azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, or mercaptopurine (within 24 weeks)
• Canakinumab, TNF inhibitors, IL-6 inhibitors, or janus-activating kinase inhibitors (within 12 weeks)
• Intravenous immune globulin (IVIG) (within 8 weeks)
• Corticosteroids (within 4 weeks)
• Known hypersensitivity to the active substance or any of the excipients of the trial
DRUG: CardiolRx
Recurrent Pericarditis
IL-1 blocker-dependent recurrent pericarditis, pharmaceutically cannabidial
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Altman Clinical and Translational Research Institute La Jolla, California Ajit Raisinghani, MD - (araisinghani@health.ucsd.edu)
Cedars-Sinai Medical Center Los Angeles, California Paul Marano, MD - (Paul.Marano@cshs.org)
Cleveland Clinic Cleveland, Ohio Saberio Lo Presti Vega, MD - (LOPRESS2@ccf.org)
Columbia University - New York Presbyterian New York, New York Dor Lotan, MD - (dl3491@cumc.columbia.edu)
Fatebenefratelli Hospital Milano Milan, Antonio Brucato, MD - (antonio.brucato@unimi.it)
Hippokration General Hospital Athens, George Lazaros, MD - (glaz35@hotmail.com)
Houston Methodist Hospital Houston, Texas
Jewish General Hospital Montreal, Quebec Vartan Mardigyan, MD - (vartan.mardigyan@mail.mcgill.ca)
Johns Hopkins University Baltimore, Maryland Luigi Adamo, MD - (ladamo2@jhmi.edu)
Lenox Hill Hospital New York, New York Dennis Finkielstein, MD - (DFinkielstei@northwell.edu)
Massachusetts General Hospital Boston, Massachusetts Jonathan Salik, MD - (jsalik@mgh.harvard.edu)
Mayo Clinic Rochester, Minnesota Sushil A Luis, MD - (luis.s@mayo.edu)
Mayo Clinic Florida Jacksonville, Florida Prajwal Reddy, MD - (reddy.prajwal@mayo.edu)
Mayo Clionic Arizona Phoenix, Arizona Chadi Ayoub, MD - (ayoub.chadi@mayo.edu)
MedStar Health Institute Columbia, Maryland Syed Haider, MD - (Waqas.Haider@medstar.net)
Minneapolis Heart Institute Minneapolis, Minnesota David Lin, MD - (David.Lin@allina.com)
NYU Langone Health New York, New York Michael Garshick, MD - (michael.garshick@nyulangone.org)
Northwestern University Chicago, Illinois Mohammed Al-Kazaz, MD - (mohamed.alkazaz@nm.org)
Pacific Heart Institute at Cedars-Sinai Santa Monica, California Rigved Tadwalker, MD - (rtadwalkar@pacificheart.com)
UCI Health Orange, California Amin Sabet, MD - (sabeta1@hs.uci.edu)
University Hospital San Antonio, Texas Alessandro Andreis, MD - (alessandro.andreis@unito.it)
University Hospital Udine Udine, Valentino Collini, MD - (valentino.collini@asufc.sanita.fvg.it)
University of Padua Padua, Alida Caforio, MD - (alida.caforio@unipd.it)
University of Utah Hospital Salt Lake City, Utah Libo Wang, MD - (Libo.Wang@utah.edu)
University of Vermont Burlington, Vermont Tracy Hagerty, MD - (tracy.hagerty@uvmhealth.org)
University of Virginia Charlottesville, Virginia Antonio Abbate, MD - (antonio.abbate@virginia.edu)
Virginia Commonwealth University Richmond, Virginia Georgia Thomas, MD - (georgia.thomas@vcuhealth.org)

Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma

ctrrecruit@vcu.edu

NCT06465316
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Inclusion Criteria:
* Patients must have histologically or cytologically confirmed multiple myeloma (MM), as defined in the International Myeloma Working Group (IMWG) criteria * If patients have undergone autologous stem cell transplant (SCT), day 0 of SCT must be \> 100 days to be eligible for the study * Patients must have had disease progression after ≥ 4 prior lines of anti-myeloma treatments including one proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), one immunomodulatory imide drug (ImiD) (e.g., thalidomide, lenalidomide, pomalidomide \[POM\]), and one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab) * Patients must have measurable disease, defined as: * Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L) * Urine M-protein ≥ 200 mg/24 h * Serum free light chain (FLC) assay: "involved" FLC level ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65) * Note: Patients with non-secretory disease will be allowed to participate * Age ≥ 18 years * Because no dosing or adverse event data are currently available on the use of iberdomide in combination with teclistamab in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60) * Hemoglobin ≥ 7.0 g/dL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin) * Absolute neutrophil count ≥ 1,000/mcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin) * Platelets ≥ 50,000/mcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin) * Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (≤ 28 days prior to registration) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN (≤ 28 days prior to registration) * Estimated glomerular filtration rate (eGFR) \> 30 mL/min (≤ 28 days prior to registration) * Spot urine (albumin/creatine ratio) ≤ 500mg/g (56 mg/mmol) OR urine dipstick negative/trace (if \> 1+ only eligible if confirmed ≤ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) (≤ 28 days prior to registration) * Note: Laboratory results obtained during screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the subject and the subsequent within range screening result may be used to confirm eligibility * 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 treated brain metastases are eligible if follow-up brain imaging done a minimum of 28 days after completion of central nervous system (CNS)-directed therapy shows no evidence of progression * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy * 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 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 II or better * Based on the mechanism of action, teclistamab may cause fetal harm when administered to a pregnant woman. Females of child-bearing potential (FCBP): should use effective contraception during treatment with teclistamab and for 5 months after the last dose. FCBP should not breast feed during treatment with teclistamab and for 5 months after the last dose. Should a FCBP become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The effects of iberdomide on the developing human fetus are unknown. However, IMiDs are known to be teratogenic. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to starting iberdomide, and again within 24 hours. FCBP must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control-one highly effective method and one additional effective method-at the same time, at least 28 days before starting iberdomide, while taking iberdomide, and for 28 days following discontinuation from the study. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with FCBP while participating in the study, during dose interruptions, and for at least 28 days following discontinuation from the study, even if he has undergone a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure * Men must agree to abstain from donating and semen or sperm while taking iberdomide, during dose interruptions, and for at least 28 days after the last dose of iberdomide. FCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period * All patients must agree to abstain from donating blood products while taking iberdomide and for at least 28 days after the last dose of iberdomide * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study subjects * Willingness to adhere to the study visit schedule and other protocol requirements and provide mandatory blood and bone marrow specimens for correlative research * Willingness to return to the enrolling institution for follow-up
Exclusion Criteria:
* Patients who have active plasma cell leukemia, active amyloid light chain (AL) (primary) amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, myeloma protein, and skin changes), and Waldenstrom macroglobulinemia are ineligible * If a patient develops recurrent/refractory (R/R) disease while receiving the most recent line of therapy, there is no need for a washout period * Patients who have had prior anti-BCMA directed bispecific antibody (BsAb) therapy exposure (prior treatment with anti-BCMA directed antibody drug conjugate, anti-BCMA-directed chimeric antigen receptor (CAR) T cell therapy, and prior non-BCMA-targeting BsAb are permitted) * Patients who have had prior treatment with a cereblon E3 ligase modulator, including mezigdomide, iberdomide, and CFT7455 (all currently in clinical development) * Patients who received plasmapheresis ≤ 7 days prior to registration * Patients who received a prior allogeneic SCT. Autologous SCT is allowed * Patients who received a live or live-attenuated vaccine ≤ 30 days prior to registration. Patients are allowed to receive a coronavirus disease 2019 (COVID-19) vaccine at any timepoint during protocol treatment * Systemic active infection requiring treatment * Any unresolved toxicity ≥ grade 2 from previous treatment except for alopecia or peripheral neuropathy up to grade 2 * Patients who have had any major surgery ≤ 4 weeks prior to registration * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous * Patients with evidence of active mucosal or internal bleeding * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria * Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or iberdomide, or any of the components of the study treatment * Patients who are taking any anticancer therapy other than hormonal therapy (for prostrate or breast cancer) and palliative radiotherapy (defined as radiation to ≤ 3 sites of active multiple myeloma) * Patients who require immunosuppressive medications including, but not limited to, systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent. Use of immunosuppressive medications for the management of iberdomide-related adverse events (AEs) or in subjects with contrast allergies is acceptable. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (e.g., intra-articular injection) is permitted. Temporary use of corticosteroids for concurrent illnesses (e.g., food allergies, computed tomography \[CT\] scan contrast hypersensitivity, pneumonia, etc.) are acceptable * Patients who require medications that are strong inhibitors or inducers of CYP3A4/5 * Patients who are receiving any other investigational agents * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous * Pregnant women are excluded from this study because iberdomide is a thalidomide analog and thalidomide is a known human teratogen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iberdomide, breastfeeding should be discontinued if the mother is treated with iberdomide. These potential risks may also apply to other agents used in this study * Patients who are unable or unwilling to undergo protocol required thromboembolism prophylaxis are excluded
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Iberdomide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Teclistamab
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
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Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Moffitt Cancer Center Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
University of Kansas Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center-Overland Park Overland Park, 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 Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
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)

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Sharon Palmer - spalmer@swog.org

NCT05561387
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Inclusion Criteria:
* Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration * Participants must have measurable disease within 28 days prior to registration as defined by any of the following: * Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR * IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR * Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) * All disease must be assessed and documented on the baseline/pre-registration tumor assessment form * Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration * For Participants Meeting "Frail" Status: * Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible * For Participants Meeting "Frail" Status: * Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Frail" Status: * Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Frail" Status: * Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present: * Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min. * Actual lab serum creatinine value with a minimum of 0.7 mg/dL. * Participants must have bone marrow function assessed and meet the below criteria ranges: * Hemoglobin between 7-8 g/dL, OR * Platelets between 50-75 x10\^9/L, OR * ANC between 0.75-1 x10\^9/L * Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM) * Revised International Staging System (R-ISS) stage III disease * Note: All labs must be performed within 28 days prior to registration * Participants must have a complete medical history and physical exam within 28 days prior to registration * Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form. * Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration) * Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4 * Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7 * Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration * All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration * Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score \[PS\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be 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 who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study * 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. 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
Exclusion Criteria:
* Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: * An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or * Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or * Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol. * Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration * Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\< 140 and DBP =\< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator. * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. * Participants must not be pregnant or nursing. 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 24 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.
DRUG: Bortezomib, DRUG: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Plasma Cell Myeloma
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21st Century Oncology-Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Advanced Breast Care Center PLLC Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
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 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
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Radiation Therapy Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Ascension Borgess Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Saint John Hospital Detroit, Michigan Site Public Contact - (karen.forman@ascension.org)
Ascension Saint Joseph Hospital Tawas City, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Rhinelander, Wisconsin Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Ascension Saint Michael's Hospital 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
Avera Cancer Institute Sioux Falls, 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)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Ben Taub General Hospital Houston, Texas
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan Site Public Contact - (karen.forman@ascension.org)
Blanchard Valley Hospital Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Borgess Medical Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.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)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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 Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Capital Region Southwest Campus Jefferson City, Missouri Site Public Contact - (amy.franken@health.missouri.edu)
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 Site Public Contact - (lori.srebinski@ascension.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)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
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)
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)
Dayton Physician LLC-Miami Valley Hospital North 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)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hines Jr VA Hospital Hines, Illinois
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
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 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)
Exeter Hospital Exeter, New Hampshire
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 Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Fremont - Rideout Cancer Center Marysville, California
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)
Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California
Genesee Cancer and Blood Disease Treatment Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Good Samaritan Regional Health Center Mount Vernon, Illinois
Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.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 Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Harrison Medical Center Bremerton, Washington Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (linda.schumacher@mymlc.com)
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.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)
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)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
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Illinois CancerCare-Dixon Dixon, Illinois
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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)
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Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
John L McClellan Memorial Veterans Hospital Little Rock, Arkansas
Jupiter Medical Center Jupiter, Florida
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)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeland Medical Center Saint Joseph Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.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)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
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Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
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)
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MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Macomb Hematology Oncology PC Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
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Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
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Mayo Clinic in Florida Jacksonville, Florida
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Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa
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Michael E DeBakey VA Medical Center Houston, Texas
Michigan Breast Specialists-Warren Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Midlands Community Hospital Papillion, Nebraska
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.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)
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Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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Northwest Oncology LLC Dyer, Indiana
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Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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Parker Adventist Hospital Parker, Colorado
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Porter Adventist Hospital Denver, Colorado
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Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho, New Mexico Site Public Contact - (WBurman@phs.org)
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Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina
Prisma Health Cancer Institute - Faris Greenville, South Carolina
Prisma Health Cancer Institute - Greer Greer, South Carolina
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Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina
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Providence Medical Foundation - Santa Rosa Santa Rosa, California
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Providence Queen of The Valley Napa, California
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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 Santa Rosa Memorial Hospital Santa Rosa, California
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Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
Research Medical Center Kansas City, Missouri Site Public Contact - (aroland@kccop.org)
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Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
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Saint Anthony's Health Alton, Illinois
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Saint Charles Health System-Redmond Redmond, Oregon
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Saint Elizabeth Regional Medical Center Lincoln, Nebraska
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Saint Francis Cancer Center Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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Saint John Macomb-Oakland Hospital Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
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Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
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Unity Hospital Fridley, Minnesota
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
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University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
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University of Rochester Rochester, New York
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VCU Community Memorial Health Center South Hill, Virginia Site Public Contact - (nemer.elmouallem@vcuhealth.org)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
Valley Radiation Oncology Peru, Illinois
Virginia Cancer Institute Richmond, Virginia Site Public Contact - (smoore@vacancer.com)
Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Wayne Hospital Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Charleston Division Charleston, West Virginia
Western Illinois Cancer Treatment Center Galesburg, Illinois
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Woodland Memorial Hospital Woodland, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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)

Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study) (WIND-PSC)

Stephen Rossi, PharmD - stephen@pscpartners.org

NCT06297993
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Inclusion Criteria:

• Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF).
• Confirmed clinical diagnosis of large duct PSC.
Exclusion Criteria:

• Clinically significant acute or chronic liver disease of an etiology other than PSC (including but not limited to metabolic-dysfunction associated steatohepatitis (MASH), PBC, HCV, HBV, or alcoholic hepatitis, Wilson's disease, alpha-1 antitryp-sin deficiency, acute or chronic drug-induced liver injury) * Patients with PSC and elements of AIH overlap are allowed to enroll * Patients with metabolic dysfunction associated steatotic liver disease (MASLD) or benign steatosis are allowed to enroll
• Small-Duct PSC.
• Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
• Clinically diagnosed infections (including acute cholangitis) and receiving treatment within the past 7 days; patients on chronic suppressive antibiotics for acute cholangitis will be allowed to enroll
• Hospitalization in the past 7 days
• UDCA dose \>28 mg/kg
• Evidence of current or historical decompensated cirrhosis based on the following clinical events: * Ascites \> Grade 2 and requiring treatment * Esophageal or gastric variceal bleeding requiring hospitalization * Hepatic encephalopathy (as defined by a West Haven score ≥ 2) * Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection * AKI-HRS according to AASLD Guidelines (Flamm 2021) * Portal hypertension based on a platelet count \< 150 × 109/L and LSM \> 15 kPa with clinical, laboratory, imaging and/or other relevant parameters
• Prior liver transplantation
• MELD 3.0 Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
• History, evidence, or high suspicion of hepatobiliary malignancies or active colon cancer based on imaging, screening laboratory values, and/or clinical symptoms. Patients with a history of colon cancer who have undergone a colectomy and have no current evidence of colon cancer will be allowed to enroll in the study.
• Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 52 weeks.
• Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.
• Prisoners or participants who are involuntarily incarcerated.
• Participants who are currently participating in an investigational PSC therapy clinical study or who have participated in such a study within the past 12 weeks
• Absence of data in medical records to assess inclusion and exclusion criteria.
PSC
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Auckland University Auckland, Yuliya Evdokimova - (yuliya@adhb.govt.nz)
Beth Israel Deaconess Medical Center Boston, Massachusetts Julie Shea - (jmshea@bidmc.harvard.edu)
California Pacific Medical Center San Francisco, California Stefanie Roberts, BS - (stefanie.roberts@sutterhealth.org)
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) Montreal, Anik Desormeaux - (anik.desormeaux.chum@ssss.gouv.qc.ca)
Indiana University Indianapolis, Indiana Rebecca Gerstorff - (rebgerst@iu.edu)
Massachusetts General Hospital Boston, Massachusetts Gary Zhang - (gzhang18@mgb.org)
Mayo Clinic Rochester, Minnesota Paige Powrie - (Powrie.Paige@mayo.edu)
Oxford University Hospitals Headington, Oxford Loren Smith - (Loren.Smith@ouh.nhs.uk)
Schiff Center for Liver Diseases / University of Miami Miami, Florida Cynthia Levy, MD - (clevy@med.miami.edu)
UC Davis Sacramento, California Samrrah Raouf - (saraouf@health.ucdavis.edu)
UT Southwestern Medical Center Dallas, Texas Lakeisha Johnson - (lakeisha.johnson@utsouthwestern.edu)
University Health Network Toronto, Ontario Claire Gage - (claire.gage@uhn.ca)
University Medical Center Hamburg-Eppendorf Hamburg, Jan-Philipp Weltzsch, MD - (j.weltzsch@uke.de)
University of Alberta Edmonton, Alberta Rebecca Miller - (rebecca.gildr@ualberta.ca)
University of California, San Francisco San Francisco, California Fawzy Barry - (fawzy.barry@ucsf.edu)
University of Milano Bicocca Milan, Monza (MB) Sarah Amato - (sarah.amato@irccs-sangerardo.it)
Virginia Commonwealth University Richmond, Virginia Caitlin Hurst, BS - (caitlin.hurst@vcuhealth.org)
Yale University New Haven, Connecticut Suzie Christopher - (suzie.christopher@yale.edu)

Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET)

Director Regulatory Affairs - langerj@nrgoncology.org

NCT05879926
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Inclusion Criteria:
* A patient cannot be considered eligible for this study unless ALL of the following conditions are met. * The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the U.S., authorization permitting release of personal health information. * Female patients must be greater than or equal to 18 years of age. * Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as: * Age 50 years or under with spontaneous menses within 12 months; or * Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or * Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or * Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range. * The patient must have an ECOG performance status of less than or equal to 2 (or Karnofsky greater than or equal to 60%). * Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. * Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. * Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy. * For patients who undergo a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS (ductal carcinoma in situ) with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. (Patients with margins positive for LCIS (lobular carcinoma in situ) are eligible without additional resection.) * For patients who undergo mastectomy, the margins must be free of residual gross tumor. (Patients with microscopic positive margins are eligible if post-mastectomy RT (radiation therapy) of the chest wall will be administered.) * Patient must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND). * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: * By pathologic evaluation, primary tumor must be pT1-3. (If N0, must be T1c or higher.) * By pathologic evaluation, ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). * Patients with positive isolated tumor cells (ITCs) in axillary nodes will be considered N0 for eligibility purposes. * Patients with micrometastatic nodal involvement (0.2-2 mm) will be considered N1. * Oncotype DX RS (recurrence score) requirements\*: * If node-negative: * Oncotype DX RS must be RS 21-25, or * Oncotype DX RS must be 16-20 and disease must be high clinical risk, defined as: low histologic grade with primary tumor size greater than 3 cm, intermediate histologic grade with primary tumor size greater than 2 cm, or high histologic grade with primary tumor size greater than 1 cm. * If 1-3 nodes involved: * Oncotype DX RS must be less than 26. \* Patients with a "Low Risk" or "MP1" MammaPrint (a genomic test that analyzes the activity of certain genes in early-stage breast cancer) result must have eligibility assessed with an Oncotype DX RS at pre-entry (see Section 3.1). Blocks or unstained slides must be sent to the Genomic Health centralized laboratory for testing at no cost to these patients. If MammaPrint High Risk or MP2, these patients are not eligible. * The tumor must be ER and/or PgR-positive (progesterone receptor) by current ASCO/CAP guidelines based on local testing results. Patients with greater than or equal to 1% ER and/or PgR staining by IHC will be classified as positive. * The tumor must be HER2-negative by current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines based on local testing results. * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry must be no more than 16 weeks. * Short course of endocrine therapy of less than 6 weeks duration before pre-entry is acceptable either as neoadjuvant or adjuvant therapy. An Oncotype DX RS must be performed on core biopsy specimen obtained prior to initiation of neoadjuvant endocrine therapy if received. * Patients with a prior or concurrent non-breast 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. This would include prior cancers treated with curative intent. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Radiation therapy should be used according to standard guidelines; the intended radiation therapy should be declared prior to pre-entry.
Exclusion Criteria:
* • Definitive clinical or radiologic evidence of metastatic disease. * pT4 (pathological state) tumors, including inflammatory breast cancer. * History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.) * If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer. * Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator. Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values: * ANC (absolute neutrophil count) less than 1200/mm3; * Platelet count less than 100,000/mm3; * Hemoglobin less than 10 g/dL; * Total bilirubin greater than ULN (upper limit of normal) for the lab or greater than 1.5 x ULN for patients who have a bilirubin elevation due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; * AST(aspartate aminotransferase)(SGOT)/ALT (alanine transminase)(SGPT): greater than 3 × institutional ULN; * Renal function of GFR (glomular filtration rate) less than 30 mL/min/1.73m2. * 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. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Any treatment with radiation therapy, chemotherapy, or biotherapy administered for the currently diagnosed breast cancer prior to pre-entry. (Patients with prior ET of more than 6 weeks duration for treatment of this cancer are not eligible.) Prior tamoxifen given for breast cancer prevention is allowed. Prior AI or GnRH for fertility preservation is allowed. * Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs). * Patients with evidence of chronic hepatitis B virus (HBV) infection are ineligible unless the HBV viral load is undetectable on suppressive therapy. Patients with a history of hepatitis C virus (HCV) infection are ineligible unless they have been treated and cured or have an undetectable HCV viral load if still on active therapy. * Pregnancy or lactation at the time of pre-entry. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry.) * Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
DRUG: Ovarian Function Suppression + Aromatase Inhibitor, DRUG: Adjuvant Chemotherapy + Ovarian Function Suppression
Breast Cancer
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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)
Abbeville General Hospital Abbeville, Louisiana
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Addison Gilbert Hospital Gloucester, Massachusetts
Advanced Breast Care Center PLLC Warren, Michigan
AdventHealth Altamonte Altamonte Springs, Florida
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 High Tech Medical Park Palos Heights, Illinois Site Public Contact - (ncorp@aah.org)
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 Outpatient Center - Oak Lawn Oak Lawn, 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 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
Allegiance Health Jackson, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California Site Public Contact - (clinicalresearch@sutterhealth.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
Annie Penn Memorial Hospital Reidsville, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Armes Family Cancer Center Findlay, Ohio
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Cancer Care-Antigo-Volm Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center Rhinelander, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care-Wausau Wausau, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
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
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Augusta Health Center for Cancer and Blood Disorders Fishersville, Virginia
Augusta Oncology Associates PC-D'Antignac Augusta, Georgia
Augusta Oncology Associates PC-Wheeler Augusta, Georgia
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)
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Health Corbin Corbin, Kentucky
Baptist Health Floyd New Albany, Indiana Site Public Contact - (Roster@nrgoncology.org)
Baptist Health Hamburg Lexington, Kentucky
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Baptist Health Medical Center - Little Rock Little Rock, Arkansas
Baptist Health Paducah Paducah, Kentucky
Baptist MD Anderson Cancer Center Jacksonville, Florida
Baptist Medical Center South Jacksonville, Florida Site Public Contact - (jan.peer@bmcjax.com)
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 Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Bayhealth Hospital Kent Campus Dover, Delaware Site Public Contact - (clinical_trials@bayhealth.org)
Bayhealth Hospital Sussex Campus Milford, Delaware Site Public Contact - (clinical_trials@bayhealth.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
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)
Bellin Memorial Hospital Green Bay, Wisconsin
Ben Taub General Hospital Houston, Texas
Benefis Helena Specialty Center Helena, Montana Site Public Contact - (mccinfo@mtcancer.org)
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
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Beverly Hospital Beverly, Massachusetts
Beverly Hospital Cancer Center at Anna Jaques Newburyport, Massachusetts
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
Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia Site Public Contact - (Anne_caramella@bshsi.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)
Bon Secours Westchester Emergency Center Midlothian, 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)
Bryn Mawr Hospital Bryn Mawr, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Health Saint Francis Grand Island, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHRISTUS Highland Medical Center Shreveport, Louisiana Site Public Contact - (Nancy.hassan@christushealth.org)
CHU de Quebec-Hopital du Saint-Sacrement (HSS) Québec, Quebec Site Public Contact - (jbegin@uresp.ulaval.ca)
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec Site Public Contact - (info.cr.chum@ssss.gouv.qc.ca)
California Pacific Medical Center-Pacific Campus San Francisco, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Camden Clark Medical Center Parkersburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Cancer Care Associates PC Royal Oak, Michigan
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 Northwest - Spokane South Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-North Spokane Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Northwest-Valley Spokane, Washington Site Public Contact - (research@ccnw.net)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Center-Metro Medical Center Bayamon Bayamón,
Cancer Centers of Southwest Oklahoma Research Lawton, Oklahoma
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Blood Specialists-Henderson Henderson, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Capital Health Medical Center-Hopewell Pennington, New Jersey
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)
Carlisle Regional Cancer Center Carlisle, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Caro Cancer Center Caro, Michigan
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Castle Medical Center Kailua, Hawaii
Cedars-Sinai Cancer - Tarzana Tarzana, California
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
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 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)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (Roster@nrgoncology.org)
Chambersburg Hospital Chambersburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Christiana Care - Union Hospital Elkton, Maryland Site Public Contact - (frank.crum@christianacare.org)
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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)
City of Hope Comprehensive Cancer Center Duarte, California
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Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Cleveland Clinic Akron General Akron, Ohio
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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 Wooster Family Health and Surgery Center Wooster, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic-Weston Weston, Florida Site Public Contact - (CancerAnswer@ccf.org)
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)
CommonSpirit Cancer Center Mercy Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital London London, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Cancer Center East Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Cancer Center North Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Cancer Center South Indianapolis, Indiana Site Public Contact - (lcheri@ecommunity.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Howard Regional Health Kokomo, Indiana Site Public Contact - (oncology@communityhoward.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Community Medical Center Missoula, Montana Site Public Contact - (cancerresearch@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)
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)
Comprehensive Medical Center PLLC Royal Oak, Michigan
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)
Cone Health Cancer Center at Alamance Regional Burlington, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Asheboro Asheboro, North Carolina
Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cone Health MedCenter Asheboro Asheboro, North Carolina Site Public Contact - (stacey.phelps@conehealth.com)
Cooper Hospital University Medical Center Camden, New Jersey
Cooperman Barnabas Medical Center Livingston, New Jersey
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's 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)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana Farber-Merrimack Valley Methuen, Massachusetts
Dana-Farber Cancer Institute Boston, Massachusetts
Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts
Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts
Danbury Hospital Danbury, Connecticut
Dartmouth Cancer Center - North Saint Johnsbury, Vermont
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Dayton Physicians LLC-Wayne Greenville, Ohio
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)
Dickinson County Healthcare System Iron Mountain, Michigan Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Dickstein Cancer Treatment Center White Plains, New York Site Public Contact - (mcortese@wphospital.org)
Dillon Health Center/Shaw Cancer Center Dillon, Colorado
Divine Providence Hospital Williamsport, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Doctors Cancer Center Manati,
Doctors Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Drexel Town Square Health Center Oak Creek, Wisconsin
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 University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, 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 Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Ehime University Hospital Tōon, Ehime
Eisenhower Medical Center Rancho Mirage, California
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Decatur Hospital Decatur, Georgia Site Public Contact - (clinicaltrialsoncology@dekalbmedical.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
Englewood Hospital and Medical Center Englewood, New Jersey
Enloe Medical Center Chico, California
Ephrata Cancer Center Ephrata, Pennsylvania
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota
Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota
Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota
Essentia Health - Saint Joseph's Staples Clinic Staples, 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 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)
FHCC Overlake Bellevue, Washington
FHCC at EvergreenHealth Kirkland, Washington
FHCC at Northwest Hospital Seattle, Washington
FMH James M Stockman Cancer Institute Frederick, Maryland
FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery Sarasota, Florida Site Public Contact - (Research-Institute@smh.com)
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.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 Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Farmington Health Center Farmington, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
First Physicians Group - Silverstein Institute at Floyd Street Sarasota, Florida Site Public Contact - (researchinstitute@smh.com)
First Physicians Group - Urology Robotic and Minimally Invasive Surgery Sarasota, Florida
FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina Site Public Contact - (jcwilliams@firsthealth.org)
Florida Cancer Specialists - Bradenton Cancer Center Bradenton, Florida Site Public Contact - (clinicaltrials@flcancer.com)
Florida Cancer Specialists - Sarasota Sarasota, Florida Site Public Contact - (Roster@nrgoncology.org)
Florida Cancer Specialists - Sarasota Downtown Sarasota, Florida Site Public Contact - (ClinicalTrials@FLCancer.com)
Florida Cancer Specialists - Venice Island Venice, Florida Site Public Contact - (Roster@nrgoncology.org)
Florida Cancer Specialists - Venice Pinebrook Venice, Florida Site Public Contact - (ClinicalTrials@FLCancer.com)
Forbes Hospital Monroeville, Pennsylvania
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
Fox Chase Cancer Center Buckingham Furlong, Pennsylvania
Franciscan Health Indianapolis Indianapolis, Indiana
Franciscan Health Mooresville Mooresville, Indiana
Franciscan Health Munster Munster, Indiana
Fred Hutchinson Cancer Center Seattle, Washington
Fred and Pamela Buffett Cancer Center - Kearney Kearney, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Frederick Memorial Hospital Frederick, Maryland
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Freeman Physician Group of Pittsburg Pittsburg, Kansas Site Public Contact - (BNMathew@freemanhealth.com)
Fremont - Rideout Cancer Center Marysville, California
Fresno Cancer Center Fresno, California Site Public Contact - (Kpoct@kp.org)
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (cancerresearch@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)
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-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)
Glens Falls Hospital Glens Falls, New York
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Good Samaritan University Hospital West Islip, New York
Goshen Center for Cancer Care Goshen, Indiana Site Public Contact - (cccois@goshenhealth.com)
Grady Health System Atlanta, Georgia
Grady Memorial Hospital Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Greater Baltimore Medical Center Baltimore, Maryland
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Gunma University Hospital Gunma, Maebashi
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
HSHS Sacred Heart Hospital Eau Claire, Wisconsin
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hackensack University Medical Center Hackensack, New Jersey
Harold Alfond Center for Cancer Care Augusta, Maine
Hartford HealthCare - Avon Avon, Connecticut
Hartford HealthCare - Manchester Manchester, Connecticut
Hartford HealthCare - Saint Vincent's Medical Center Bridgeport, Connecticut
Hartford Hospital Hartford, Connecticut
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)
Hawaii Diagnostic Radiology Services LLC Honolulu, Hawaii Site Public Contact - (mmiyoshi@hawaiidrs.com)
HaysMed Hays, Kansas
Health Central Ocoee, Florida Site Public Contact - (Roster@nrgoncology.org)
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 Fredericksburg Inc Fredericksburg, Virginia Site Public Contact - (cvaughn@hoafredericksburg.com)
Hematology Oncology Consultants PC-Royal Oak Royal Oak, Michigan
Hematology Oncology Consultants PC-Troy Troy, Michigan
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 Cancer Institute-Downriver Brownstown, Michigan Site Public Contact - (CTOResearch@hfhs.org)
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 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 Madison Heights Hospital - Breast Warren, Michigan Site Public Contact - (kforman1@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Fairlane Dearborn, Michigan Site Public Contact - (CTOResearch@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)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Wyandotte Hospital Wyandotte, Michigan Site Public Contact - (nhay@hfhs.org)
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (Roster@nrgoncology.org)
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Hiroshima University Hospital Hiroshima,
Hokkaido University Hospital Sapporo, Hokkaido Site Public Contact - (hassi@med.hokudai.ac.jp)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Holy Name Hospital Teaneck, New Jersey
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
Hospital de Clinicas Dr Manuel Quintela Montevideo, Site Public Contact - (comunicaciones@msp.gub.uy)
Houston Methodist Cypress Hospital Cypress, Texas Site Public Contact - (irb@houstonmethodist.org)
Houston Methodist Hospital Houston, Texas
Houston Methodist Saint John Hospital Nassau Bay, Texas Site Public Contact - (Roster@nrgoncology.org)
Houston Methodist San Jacinto Hospital Baytown, Texas Site Public Contact - (Roster@nrgoncology.org)
Houston Methodist Sugar Land Hospital Sugar Land, Texas
Houston Methodist The Woodlands Hospital The Woodlands, Texas Site Public Contact - (hmthewoodlands@houstonmethodist.org)
Houston Methodist West Hospital Houston, Texas
Huntington Memorial Hospital Pasadena, California
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)
Hyogo Cancer Center Akashi, Hyōgo
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
IU Health West Hospital Avon, Indiana Site Public Contact - (iutrials@iu.edu)
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 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)
Indu and Raj Soin Medical Center Beavercreek, Ohio
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Instituto Nacional De Cancerologia Bogotá,
Instituto Nacional De Cancerologia de Mexico Mexico City, Tlalpan
Instituto Nacional de Enfermedades Neoplasicas Lima,
Intercoastal Medical Group - Cattleridge II Sarasota, Florida
Intermountain Health Lutheran Hospital Wheat Ridge, Colorado
Intermountain Health West End Clinic Billings, Montana
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 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
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Jupiter Medical Center Jupiter, Florida Site Public Contact - (clinicaltrials@jupitermed.com)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kaiser Permanente - Kensington Medical Center Kensington, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.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 Cancer Treatment Center South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, 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 Oakland-Broadway Oakland, California Site Public Contact - (Kpoct@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 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- Modesto MOB II Modesto, 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-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-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-Rancho Cordova Cancer Center Rancho Cordova, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Richmond Richmond, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Rio San Diego San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
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)
Kaiser Sunnyside Medical Center Clackamas, Oregon
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Keck Medical Center of USC Pasadena Pasadena, California
Keck Medicine of USC Buena Park Buena Park, California
Keck Medicine of USC Koreatown Los Angeles, California
Kent Hospital Warwick, Rhode Island
Kettering Medical Center Kettering, Ohio
King's Daughter's Medical Center Ashland, Kentucky
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.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)
Kuakini Medical Center Honolulu, Hawaii
Kyoto University Hospital Kyoto,
LSU Health Sciences Center at Shreveport Shreveport, Louisiana Site Public Contact - (LPost@lsuhsc.edu)
Lahey Clinic Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Clinic Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeridge Health Oshawa Oshawa, Ontario
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Lancaster General Ann B Barshinger Cancer Institute Lancaster, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
Lankenau Medical Center Wynnewood, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Las Vegas Prostate Cancer Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Green Valley Henderson, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Las Vegas Urology - Sunset Las Vegas, Nevada
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)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lenox Hill Hospital New York, New York
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
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah, Georgia Site Public Contact - (underberga@sjchs.org)
Liberty Hospital Liberty, Missouri
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loma Linda University Medical Center Loma Linda, California
London Regional Cancer Program London, Ontario
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Los Angeles General Medical Center Los Angeles, California
Louisiana Hematology Oncology Associates LLC Baton Rouge, Louisiana Site Public Contact - (clinicalresearch@marybird.com)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Lowell General Hospital Lowell, Massachusetts Site Public Contact - (cancerclinicaltrials@tuftsmedicine.org)
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
Luminis Health Anne Arundel Medical Center Annapolis, Maryland
Lutheran Hospital - Cancer Centers of Colorado Golden, Colorado Site Public Contact - (peaksresearch@imail.org)
Lyndon Baines Johnson General Hospital Houston, Texas
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
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 LincolnHealth Hospital Damariscotta, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center - Biddeford Biddeford, Maine
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Waldo Hospital Belfast, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Manhattan Eye Ear and Throat Hospital New York, New York
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Markey Cancer Center at Lexington Clinic Lexington, Kentucky
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 Bird Perkins Cancer Center - Covington Covington, Louisiana Site Public Contact - (clinicalresearch@marybird.com)
Mary Greeley Medical Center Ames, Iowa
Mary Lanning Memorial Hospital Hastings, Nebraska
Matthews Radiation Oncology Center Matthews, North Carolina Site Public Contact - (kashah@novanthealth.org)
Mayo Clinic Health System-Franciscan Healthcare La Crosse, Wisconsin
Mayo Clinic Health Systems-Mankato Mankato, Minnesota
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
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
McLaren Cancer Institute-Bay City Bay City, Michigan Site Public Contact - (ctoadmin@karmanos.org)
McLaren Cancer Institute-Clarkston Clarkston, 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)
Mease Countryside Hospital Safety Harbor, Florida Site Public Contact - (research.cto@baycare.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)
MedStar Health Bel Air Medical Campus Bel Air, Maryland Site Public Contact - (David.j.perry2@medstar.net)
MedStar Montgomery Medical Center Olney, Maryland
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 North Colorado Springs, Colorado
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Hospital of Laramie County Cheyenne, Wyoming Site Public Contact - (Roster@nrgoncology.org)
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)
Mercy Cancer Center Merced, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
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 Pittsburg Pittsburg, Kansas
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 Durango, Colorado Site Public Contact - (acline@mdmercy.com)
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 Site Public Contact - (ResearchInstituteInquiries@commonspirit.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)
Methodist Willowbrook Hospital Houston, Texas Site Public Contact - (Roster@nrgoncology.org)
Miami Cancer Institute Miami, Florida
Miami Cancer Institute at Plantation Plantation, Florida
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)
Michigan Institute of Urology-Town Center Troy, Michigan
Mid Coast Hospital Brunswick, Maine Site Public Contact - (Roster@nrgoncology.org)
Midlands Community Hospital Papillion, Nebraska
Midstate Medical Center Meriden, Connecticut
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
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 - Coon Rapids Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Edina Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Chaska Chaska, 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
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
Morton Plant Hospital Clearwater, Florida
Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Hospital Medical Center Chicago, Illinois Site Public Contact - (suhi@sinai.org)
Mount Sinai Medical Center New York, New York Site Public Contact - (Yvonne.Enriquez@msmc.com)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
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)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas Site Public Contact - (Emily.Carvell@bmhcc.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Hudson Valley Hospital Cortlandt Manor, New York
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Brooklyn Brooklyn, New York Site Public Contact - (david.wallach@nyulangone.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nagoya University Hospital Showa-Ku Nagoya,
National Cancer Center Hospital Chūōku, Site Public Contact - (www-admin@ncc.go.jp)
National Jewish Health-Main Campus Denver, Colorado
National Jewish Health-Northern Hematology Oncology Thornton, Colorado
National Jewish Health-Western Hematology Oncology Golden, Colorado Site Public Contact - (glicht@co-cancerresearch.org)
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
Neurosurgeons of New Jersey-Ridgewood Ridgewood, New Jersey
New England Cancer Specialists Westbrook, Maine
New England Cancer Specialists - Kennebunk Kennebunk, Maine Site Public Contact - (research@newecs.org)
New England Cancer Specialists - Topsham Topsham, Maine Site Public Contact - (research@newecs.org)
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 Westchester Hospital Bronxville, New York
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)
Newland Medical Associates-Clarkston Clarkston, Michigan
Newland Medical Associates-Pontiac Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
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 Shore Medical Center Skokie, Illinois Site Public Contact - (Roster@nrgoncology.org)
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
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 Imbert Cancer Center Bay Shore, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
Northwest Hospital Center Randallstown, Maryland Site Public Contact - (cancerinstitute@lifebridgehealth.org)
Northwest Wisconsin Cancer Center Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
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)
Norwalk Hospital Norwalk, Connecticut Site Public Contact - (jennifer.long@norwalkhealth.org)
Novant Health Breast Surgery - Greensboro Greensboro, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Huntersville Huntersville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Kernersville Kernersville, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Matthews Matthews, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mooresville Mooresville, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Mount Airy Mount Airy, North Carolina Site Public Contact - (asmarrs@novanthealth.org)
Novant Health Cancer Institute - Rowan Salisbury, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Cancer Institute - Statesville Statesville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Thomasville Thomasville, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Cancer Institute - Wilkesboro North Wilkesboro, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Colon and Rectal Clinic Clemmons, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Forsyth Medical Center Winston-Salem, North Carolina Site Public Contact - (pjordan@novanthealth.org)
Novant Health Presbyterian Medical Center Charlotte, North Carolina Site Public Contact - (kashah@novanthealth.org)
Novant Health Presbyterian Medical Center Huntersville Huntersville, North Carolina Site Public Contact - (kashah@novanthealth.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)
OSF Saint Francis Medical Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Joseph Medical Center Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Oakland Colon Rectal Associates Royal Oak, Michigan
Oakland Medical Group Royal Oak, Michigan
Oakville Trafalgar Memorial Hospital Oakville, Ontario
Ochsner Hematology Oncology North Shore - Covington (West Region) Covington, Louisiana
Ochsner LSU Health - Cancer Treatment Center Shreveport, Louisiana
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 Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Pickerington Methodist Hospital Pickerington, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Westerville Medical Campus/Westerville Cancer Center Westerville, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Okayama University Hospital Okayama, Site Public Contact - (Roster@nrgoncology.org)
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
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.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)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Orion Cancer Care Findlay, Ohio
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)
Overlook Hospital Summit, New Jersey
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
PROncology San Juan, Site Public Contact - (info@PRoncology.com)
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)
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 Health Center - Farmington Farmington, Missouri
Parkview Regional Medical Center Fort Wayne, Indiana
PeaceHealth Saint John Medical Center Longview, Washington Site Public Contact - (kmakin-bond@peacehealth.org)
PeaceHealth Saint Joseph Medical Center Bellingham, Washington Site Public Contact - (achapman1@peacehealth.org)
PeaceHealth Southwest Medical Center Vancouver, Washington
PeaceHealth United General Medical Center Sedro-Woolley, Washington Site Public Contact - (achapman1@peacehealth.org)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Penobscot Bay Medical Center Rockport, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
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)
Pluta Cancer Center Rochester, New York Site Public Contact - (Roster@nrgoncology.org)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Pomona Valley Hospital Medical Center Pomona, California
Premier Blood and Cancer Center Dayton, Ohio
Premier Hematology Oncology Care Sterling Heights, Michigan
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)
Princeton Community Hospital Princeton, West Virginia
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
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProHealth Waukesha Memorial Hospital Waukesha, 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 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 Medical Foundation - Santa Rosa Santa Rosa, California
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 Queen of The Valley Napa, California
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 Santa Rosa Memorial Hospital Santa Rosa, California
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Puerto Rico Hematology Oncology Group Bayamón,
Queen's Cancer Cenrer - POB I Honolulu, Hawaii
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
Radiation Oncology Associates Reno, Nevada
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)
Rapid City Regional Hospital Rapid City, South Dakota
Reading Hospital West Reading, Pennsylvania
Reading Hospital McGlinn Cancer Institute at Phoenixville Phoenixville, Pennsylvania
Redeemer Health Meadowbrook, Pennsylvania
Regional Cancer Center-Lee Memorial Health System Fort Myers, Florida
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riddle Memorial Hospital Media, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
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 Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Riverwood Healthcare Center Aitkin, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Robert and Carol Weissman Cancer Center at Martin Health Stuart, Florida
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Rohnert Park Cancer Center Rohnert Park, California Site Public Contact - (Kpoct@kp.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rowan Regional Medical Center Salisbury, North Carolina Site Public Contact - (nnechiporchik@novanthealth.org)
Royal Victoria Regional Health Centre Barrie, Ontario
Rush MD Anderson Cancer Center Chicago, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush MD Anderson Cancer Center at Rush Lisle Lisle, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush MD Anderson Cancer Center at Rush Oak Park Oak Park, Illinois Site Public Contact - (Cancer_Studies@rush.edu)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois
Rutgers Cancer Institute of New Jersey New Brunswick, 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)
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 Anthony North Hospital Westminster, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Anthony's Hospital Cancer Care Center St. Petersburg, Florida Site Public Contact - (Research.CTO@baycare.org)
Saint Charles Health System Bend, Oregon Site Public Contact - (nosall@stcharleshealthcare.org)
Saint Charles Health System-Redmond Redmond, Oregon
Saint Elizabeth Boardman Hospital Boardman, Ohio
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio
Saint Francis Cancer Center Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Francis Cancer Center Colorado Springs, Colorado Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Federal Way, Washington Site Public Contact - (Heather_Rich@bshsi.org)
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 James Community Hospital and Cancer Treatment Center Butte, Montana
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Hospital - Cancer Centers of Colorado Denver, Colorado
Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Joseph Warren Hospital Warren, Ohio
Saint Joseph's Medical Center Stockton, California
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
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 - 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-Miners Campus Coaldale, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus Bethlehem, Pennsylvania
Saint Mary Corwin Medical Center Pueblo, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary's Hospital Centralia, Illinois
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 Patrick Hospital - Community Hospital Missoula, Montana Site Public Contact - (amy.hanneman@providence.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)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Saitama Medical University International Medical Center Hidaka,
Salina Regional Health Center Salina, Kansas Site Public Contact - (mleepers@srhc.com)
Salinas Valley Memorial Salinas, California Site Public Contact - (tnielsen2@svmh.com)
San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
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)
Santa Cruz Radiation Oncology Medical Group Santa Cruz, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida
Sarasota Memorial Hospital Sarasota, Florida
Sarasota Memorial Hospital-Venice N. Venice, Florida
Saskatoon Cancer Centre Saskatoon, Saskatchewan
Schoolcraft Memorial Hospital Manistique, Michigan Site Public Contact - (WI_research_admin@hshs.org)
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)
Shikoku Cancer Center Matsuyama,
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)
Sidney and Lois Eskenazi Hospital Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Sinai Hospital of Baltimore Baltimore, Maryland
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)
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
South Carolina Cancer Specialists PC Hilton Head Island, South Carolina Site Public Contact - (underberga@sjchs.org)
South Georgia Medical Center/Pearlman Cancer Center Valdosta, Georgia Site Public Contact - (maryann.heddon@sgmc.org)
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)
South Sacramento Cancer Center Sacramento, California Site Public Contact - (Kpoct@kp.org)
Southern Illinois University School of Medicine Springfield, Illinois
Southpointe-Sanford Medical Center Fargo Fargo, North Dakota
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)
Stamford Hospital/Bennett Cancer Center Stamford, Connecticut
Stanford Cancer Center Emeryville Emeryville, California Site Public Contact - (cancertrialsinfo@stanford.edu)
Stanford Cancer Center South Bay San Jose, California Site Public Contact - (cancertrialsinfo@stanford.edu)
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (cancertrialsinfo@stanford.edu)
Staten Island University Hospital Staten Island, New York
Stony Brook University Medical Center Stony Brook, New York
Straub Clinic and Hospital Honolulu, Hawaii
Straub Medical Center - Kahului Clinic Kahului, Hawaii Site Public Contact - (lori.kam@hawaiipacifichealth.org)
Straub Pearlridge Clinic ‘Aiea, Hawaii
Summa Health Medina Medical Center Medina, Ohio Site Public Contact - (cancerresearch@summahealth.org)
Summa Health System - Akron Campus Akron, Ohio Site Public Contact - (cancerresearch@summahealth.org)
Summa Health System - Barberton Campus Barberton, Ohio Site Public Contact - (cancerresearch@summahealth.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)
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-Cameron Park Cameron Park, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Cancer Research Consortium Novato, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sutter Davis Hospital Davis, California Site Public Contact - (NCIclinicaltrials@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)
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)
Tamarack Health Hayward Medical Center Hayward, Wisconsin
Temple Health - Chestnut Hill Hospital Philadelphia, Pennsylvania
Temple University Hospital Philadelphia, Pennsylvania
Texas Tech University Health Sciences Center-Lubbock Lubbock, Texas
The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles, California Site Public Contact - (ctsucontact@westat.com)
The Cancer Center of Hawaii-Liliha Honolulu, Hawaii
The Cancer Center of Hawaii-Pali Momi ‘Aiea, Hawaii
The Cancer Institute Hospital of JFCR Koto-ku, Tokyo Site Public Contact - (gog-jpn@insti.kitasato-u.ac.jp)
The Cancer Institute at Saint Francis Hospital East Hills, New York Site Public Contact - (Stephanie.Solito@chsli.org)
The Cancer Institute of New Jersey Hamilton Hamilton, New Jersey
The Christ Hospital Cincinnati, Ohio
The Don and Sybil Harrington Cancer Center Amarillo, Texas Site Public Contact - (Gina.Cravey@bsahs.org)
The Hospital of Central Connecticut New Britain, Connecticut
The Iowa Clinic PC West Des Moines, Iowa
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 - (Roster@nrgoncology.org)
The Permanente Medical Group-Roseville Radiation Oncology Roseville, California Site Public Contact - (Kpoct@kp.org)
The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii Site Public Contact - (rohta@queens.org)
The University of Kansas Cancer Center - Olathe Olathe, Kansas Site Public Contact - (OlatheCCResearch@kumc.edu)
The Valley Hospital - Luckow Pavilion Paramus, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
The West Clinic - Wolf River Germantown, Tennessee Site Public Contact - (afletcher@westclinic.com)
ThedaCare Cancer Care - Berlin Berlin, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
ThedaCare Cancer Care - Shawano Shawano, Wisconsin Site Public Contact - (ResearchDept@thedacare.org)
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)
Torrance Memorial Physician Network - Cancer Care Torrance, California Site Public Contact - (courtney.steeneken@tmphysicians.com)
Touro Infirmary New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Tower Cancer Research Foundation Beverly Hills, California Site Public Contact - (towercancerresearch@toweroncology.com)
TriHealth Cancer Institute-Anderson Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
TriHealth Cancer Institute-Westside Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus Elizabeth, New Jersey
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan
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 Muskegon Hospital Muskegon, Michigan
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)
Trinity Medical Center Moline, Illinois
Tripler Army Medical Center Honolulu, Hawaii
Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
Tufts Medical Center Cancer Center Stoneham Stoneham, Massachusetts Site Public Contact - (NCCCR@Tuftsmedicalcenter.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCHealth - Cherry Creek Denver, Colorado Site Public Contact - (Roster@nrgoncology.org)
UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado
UCHealth Lone Tree Health Center Lone Tree, Colorado Site Public Contact - (Roster@nrgoncology.org)
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UCHealth University of Colorado Hospital Aurora, Colorado
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
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
UI Healthcare Mission Cancer and Blood - Fort Dodge Fort Dodge, Iowa Site Public Contact - (trials@missioncancer.com)
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland
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 Doral Doral, Florida Site Public Contact - (kginnity@med.miami.edu)
UM Sylvester Comprehensive Cancer Center at Kendall Miami, Florida
UM Sylvester Comprehensive Cancer Center at Plantation Plantation, Florida
UM Upper Chesapeake Hematology and Oncology - Aberdeen Aberdeen, Maryland
UM Upper Chesapeake Medical Center Bel Air, Maryland
UMC Cancer Center / UMC Health System Lubbock, Texas
UNC Health Cancer Care Cary Cary, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
UNC Health Cancer Care Garner Garner, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
UNC Health Cancer Care Raleigh Raleigh, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
UNC Health Cancer Care Wakefield Raleigh, North Carolina Site Public Contact - (CancCtrOncologyClinicalResearch@unchealth.unc.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
UP Health System Hematology Oncology Marquette Marquette, Michigan Site Public Contact - (Dianna.Larson@mghs.org)
UP Health System Marquette Marquette, Michigan Site Public Contact - (Dianna.Larson@mghs.org)
UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)
UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
UPMC Hillman Cancer Center - Monroeville Monroeville, Pennsylvania Site Public Contact - (ClinicalResearchServices@upmc.edu)
UPMC Hillman Cancer Center - New Castle New Castle, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center - Passavant - Cranberry Cranberry Township, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Hillman Cancer Center Erie Erie, Pennsylvania Site Public Contact - (ClinicalResearchServices@upmc.edu)
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania Site Public Contact - (klitchfield@PINNACLEHEALTH.org)
UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown, Pennsylvania
UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania
UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania
UPMC-Shadyside Hospital Pittsburgh, Pennsylvania
USC / Norris Comprehensive Cancer Center Los Angeles, California
USC Norris Oncology/Hematology-Newport Beach Newport Beach, California
UT MD Anderson - League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT MD Anderson - Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT MD Anderson - The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT MD Anderson - West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UTMB Cancer Center at Victory Lakes League City, Texas
UTMB Health Angleton Danbury Campus Angleton, Texas
UW Cancer Center at ProHealth Care Waukesha, Wisconsin
UW Health Carbone Cancer Center Rockford Rockford, Illinois Site Public Contact - (lkline@uwhealth.org)
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
University Cancer and Blood Center LLC Athens, Georgia Site Public Contact - (research@universitycancer.com)
University Health Truman Medical Center Kansas City, Missouri
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 Alabama at Birmingham Cancer Center Birmingham, Alabama
University of Arkansas for Medical Sciences Little Rock, Arkansas
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 Hawaii Cancer Center Honolulu, Hawaii
University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa Site Public Contact - (katherine-daprile@uiowa.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - Briarcliff Kansas City, Missouri
University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - North Kansas City, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center at North Kansas City Hospital North Kansas City, Missouri
University of Kansas Cancer Center-Overland Park Overland Park, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Health System Saint Francis Campus Topeka, Kansas
University of Kansas Hospital-Indian Creek Campus Overland Park, 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 Kentucky/Markey Cancer Center Lexington, Kentucky
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 Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami, Florida Site Public Contact - (kginnity@med.miami.edu)
University of Michigan - Brighton Center for Specialty Care Brighton, Michigan
University of Michigan Health - Sparrow Lansing Lansing, Michigan Site Public Contact - (harsha.trivedi@umhsparrow.org)
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Michigan Rogel Cancer Center Ann Arbor, Michigan Site Public Contact - (CancerAnswerLine@med.umich.edu)
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 North Carolina-Hillsborough Campus Hillsborough, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Pennsylvania/Abramson Cancer Center Philadelphia, Pennsylvania Site Public Contact - (PMCancerResearch@pennmedicine.upenn.edu)
University of Rochester Rochester, New York
University of Tennessee - Knoxville Knoxville, Tennessee
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Texas Medical Branch Galveston, Texas
University of Utah Sugarhouse Health Center Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
University of Vermont Medical Center Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Washington Medical Center - Montlake Seattle, Washington
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)
UofL Health Medical Center Northeast Louisville, Kentucky
Upper Valley Medical Center Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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 Community Memorial Health Center South Hill, Virginia Site Public Contact - (nemer.elmouallem@vcuhealth.org)
VCU Massey Cancer Center at Stony Point Richmond, Virginia Site Public Contact - (ctoclinops@vcu.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia
Valley Health System Ridgewood Campus Ridgewood, New Jersey Site Public Contact - (clinicaltrialsresearch@valleyhealth.com)
Valley Health System-Hematology/Oncology Westwood, New Jersey
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Valley Medical Group - Wayne Multispecialty Practice Wayne, New Jersey
Valley Radiation Oncology Peru, Illinois
Vassar Brothers Medical Center Poughkeepsie, New York
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)
Virginia Mason Medical Center Seattle, Washington Site Public Contact - (cancerresearch@virginiamason.org)
Virtua Samson Cancer Center Moorestown, New Jersey Site Public Contact - (nctn@pennmedicine.upenn.edu)
Virtua Voorhees Voorhees Township, New Jersey Site Public Contact - (nctn@pennmedicine.upenn.edu)
WVUH-Berkely Medical Center Martinsburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Wake Forest University at Clemmons Clemmons, North Carolina
WakeMed Cancer Care- Hematology and Medical Oncology - Raleigh Raleigh, North Carolina Site Public Contact - (TCHILDRESS@wakemed.org)
Walter Knox Memorial Hospital Emmett, Idaho
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Waterloo Regional Health Network Kitchener, Ontario Site Public Contact - (research@wrhn.ca)
Waverly Hematology Oncology Cary, North Carolina Site Public Contact - (TCHILDRESS@wakemed.org)
Wayne Hospital Greenville, Ohio
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)
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
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Penn Hospital Pittsburgh, Pennsylvania
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
Wexford Health and Wellness Pavilion Wexford, Pennsylvania Site Public Contact - (Dawnmarie.DeFazio@ahn.org)
Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii
William E Kahlert Regional Cancer Center/Sinai Hospital Westminster, Maryland
Wilmot Cancer Institute at Webster Webster, New York
Winter Haven Hospital Winter Haven, Florida Site Public Contact - (Research.CTO@baycare.org)
Women and Infants Hospital Providence, Rhode Island
Woodland Memorial Hospital Woodland, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.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)
Yolanda G Barco Oncology Institute Meadville, Pennsylvania Site Public Contact - (Roster@nrgoncology.org)

A Dose-Escalation and Expansion Study of Tacabrutideg (BGB-16673) in Participants With B-Cell Malignancies (CaDAnCe-101)

BeOne Medicines - clinicaltrials@beonemed.com

NCT05006716
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Inclusion Criteria :
• Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R/R follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), R/R diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.
• Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
• For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
• Phase 2 Cohorts in R/R CLL/SLL, R/R MCL, and R/R WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.
• Measurable disease by radiographic assessment or serum IgM level (WM only)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
• Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL/SLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).
Exclusion Criteria:

• Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
• Requires ongoing systemic treatment for any other malignancy
• Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
• Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
• Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DRUG: Tacabrutideg
B-cell Malignancy, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma
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Study Locations

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Location Contacts
Aichi Cancer Center Hospital Clinical Oncology Nagoya, Aichi-ken
American Oncology Partners of Maryland Pa Bethesda, Maryland
Arensia Exploratory Medicine Llc Tbilisi,
Arthur Je Child Comprehensive Cancer Centre Calgary, Alberta
Asan Medical Center Seoul,
Augusta University Augusta, Georgia
Austin Health Heidelberg,
British Columbia Cancer Agency the Vancouver Centre Vancouver, British Columbia
CHU Henri Mondor Créteil,
Calvary Mater Newcastle Waratah, New South Wales
Cancer Institute Hospital of Jfcr Kotoku, Tokyo
Centre Henri Becquerel Rouen,
Centre Leon Berard Lyon,
Centre de Lutte Contre Le Cancer Institut Bergonie Bordeaux,
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Porto Alegre,
Centroricerche Cliniche Di Verona Srl Verona,
Chiba Cancer Center Chiba,
Chu Montpellier Hopital Saint Eloi Montpellier,
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) Québec, Quebec
Columbia University Medical Center New York, New York
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Concord Repatriation General Hospital Concord, New South Wales
Cross Cancer Institute Edmonton, Alberta
Dana Farber Cancer Institute Boston, Massachusetts
Derriford Hospital Plymouth,
Dokuz Eylul University Balçova,
Edinburgh Cancer Centre Edinburgh,
Erciyes University Kayseri,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fred Hutchinson Cancer Research Center Seattle, Washington
Freeman Hospital Newcastle upon Tyne, England
Genesiscare Cambridge Newmarket,
Henan Cancer Hospital Zhengzhou,
Honor Health Research Institute Scottsdale, Arizona
Hopital Claude Huriez Chu Lille Lille,
Hopital Estaing ClermontFerrand,
Hopital de la Pitie Salpetriere Paris,
Hospital Clinico Universitario de Valencia Valencia,
Hospital Erasto Gaertner Curitiba,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Nove de Julho Dasa São Paulo,
Hospital Sirio Libanes Brasilia Brasília,
Hospital Universitario Fundacion Jimenez Diaz Madrid,
Hospital Universitario La Paz Madrid,
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda, Madrid
Hospital Universitario Vall Dhebron Barcelona,
Inje University Busan Paik Hospital BusanjinGu, Busan Gwang'Yeogsi
Institut Paoli Calmettes Marseille,
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch Tianjin, Tianjin Municipality
Instituto Dor de Pesquisa E Ensino Sao Paulo São Paulo,
Istituto Europeo Di Oncologia Milan,
Karmanos Cancer Institute Detroit, Michigan
Karolinska Universitetssjukhuset Solna Stockholm, Stockholm County
Klinikum Grosshadern Ludwig Maximilians Universitat Munchen München,
Klinikum Johannes Gutenberg Universitaet Mainz Mainz,
Linear Clinical Research Nedlands, Western Australia
MD Anderson Cancer Center Houston, Texas
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Mayo Clinic Jacksonville Jacksonville, Florida
Mayo Clinic Phoenix Phoenix, Arizona
Mayo Clinic Rochester Rochester, Minnesota
Md Anderson Cancer Center Madrid Spain Madrid,
Memorial Sloan Kettering Cancer Center MSKCC New York, New York
Midwestern Regional Medical Center Zion, Illinois
Mount Sinai Medical Center Braman Comprehensive Cancer Center Miami, Florida
Nanfang Hospital, Southern Medical University Guangzhou, Guangdong
National Cancer Center Hospital East Kashiwa,
Niguarda Cancer Center Division of Hematology Milan,
Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich,
Norton Cancer Institute Pavilion Louisville, Kentucky
Nottingham University Hospitals NHS Trust Nottingham,
Ondokuz Mayis University Samsun,
Ospedale San Raffaele Milan,
Peking Union Medical College Hospital Beijing,
Perth Blood Institute West Perth, Western Australia
Peter MacCallum Cancer Centre Melbourne, Victoria
Policlinico Sorsola Malpighi, Aou Di Bologna Bologna,
Princess Alexandra Hospital Woolloongabba, Queensland
Princess Margaret Cancer Centre Toronto,
Pusan National University Hospital Busan,
Real E Benemerita Associacao Portuguesa de Sao Paulo São Paulo,
Roswell Park Comprehensive Cancer Center Buffalo, New York
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai Municipality
Sahlgrenska University Hospital Hematology Gothenburg,
Sakarya Training and Research Hospital Sakarya,
Samsung Medical Center Seoul,
Seoul National University Hospital Seoul,
Severance Hospital Yonsei University Health System Seoul,
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo,
Southeastern Regional Medical Center Lumberton, North Carolina
St Jamess University Hospital Leeds,
St Vincents Hospital Melbourne Fitzroy,
Stanford Medicine Palo Alto, California
Tampa General Hospital Cancer Institute Tampa, Florida
Tennesse Oncology Chattanooga Downtown Chattanooga, Tennessee
Tennessee Oncology, Pllc Nashville Nashville, Tennessee
The Alfred Hospital Melbourne,
The Catholic University of Korea, Seoul St Marys Hospital SeochoGu, Seoul Teugbyeolsi
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The Institute of Oncology, Arensia Exploratory Medicine Chisinau,
UCLA Santa Monica Cancer Care Santa Monica, California
Uchealth North Fort Collins, Colorado
Uniklinik Koeln (Aoer) Cologne,
Universitaetsklinikum Schleswig Holstein Campus Luebeck Lübeck,
Universitaetsklinikum Ulm Ulm,
Universitares Krebszentrum Leipzig Leipzig,
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden Dresden,
University of Alabama at Birmingham Hospital Birmingham, Alabama
University of Arizona Cancer Center Tucson, Arizona
University of California San Diego (Ucsd) Moores Cancer Center La Jolla, California
University of Iowa Hospitals and Clinics Iowa City, Iowa
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Weill Cornell Medical College Newyork Presbyterian Hospital New York, New York
Yichang Central Peoples Hospitaljiangnan Branch Yichang, Hubei
Yokohama Municipal Citizens Hospital Yokohama,

Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics (COSMIC)

Karen Craver - NCORP@wfusm.edu

NCT06418204
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Inclusion Criteria:
* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified). * Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment. * Participants must be able to comprehend English or Spanish (for survey completion). * Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location. * Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment. * Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey * In the treating provider's opinion, the participant should have a life expectancy of \>=6 months. Participants in hospice are not eligible. Optional Sub-study (available at select sites only): * Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU). * Must be receiving treatment at the WF CCC and VCU. * Must be diagnosed with non-small cell lung cancer. * Must be planning to receive paclitaxel as part of their chemotherapy in conjunction with Immune Checkpoint Inhibitor (ICIs) PD-1, PD-L1 or CTLA-4.
Exclusion Criteria:
* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms. * Participants with known pregnancy. * Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy. * Participants enrolled in hospice. Optional Substudy (available at select sites only): * Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). The use of glucocorticoids as pre-medications for chemotherapy treatment is allowed. * Participants with a history of HIV, hepatitis B or hepatitis C.
OTHER: Non-interventional Study
Breast Carcinoma, Colorectal Carcinoma, Lung Non-Small Cell Carcinoma, Melanoma, Non-Hodgkin Lymphoma
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Study Locations

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Location Contacts
AMG Crystal Lake - Oncology Crystal Lake, Illinois - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota - (mmcorc@healthpartners.com)
Adams Cancer Center Gettysburg, Pennsylvania
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate High Tech Medical Park Palos Heights, Illinois - (ncorp@aah.org)
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Outpatient Center - Aurora Aurora, Illinois - (ncorp@aah.org)
Advocate Outpatient Center - Oak Lawn Oak Lawn, Illinois - (ncorp@aah.org)
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
AnMed Health Cancer Center Anderson, South Carolina - (rhonda.ballew@anmedhealth.org)
Annie Penn Memorial Hospital Reidsville, North Carolina - (stacey.phelps@conehealth.com)
Armes Family Cancer Center Findlay, Ohio - (clinical.trials@daytonncorp.org)
Ascension All Saints Hospital Racine, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Calumet Hospital Chilton, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Columbia Saint Mary's Hospital Ozaukee Mequon, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Mercy Hospital Oshkosh, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Saint Elizabeth Hospital Appleton, Wisconsin - (AWRI.inquiry@ascension.org)
Ascension Saint Francis - Reiman Cancer Center Franklin, Wisconsin - (AWRI.Inquiry@Ascension.org)
Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield, Wisconsin - (AWRI.Inquiry@Ascension.org)
Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Langlade Hospital Antigo, Wisconsin - (Juli.Alford@aspirus.org)
Aspirus Medford Hospital Medford, Wisconsin - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Atrium Health Cabarrus/LCI-Concord Concord, North Carolina
Atrium Health Cleveland/LCI-Cleveland Shelby, North Carolina
Atrium Health Navicent Macon, Georgia - (andrew.weatherall@atriumhealth.org)
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
Augusta Health Center for Cancer and Blood Disorders Fishersville, Virginia
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin - (ncorp@aurora.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital for Women Memphis, Tennessee - (BCCclintrials@bmhcc.org)
Beaufort Memorial Hospital Beaufort, South Carolina - (kwade@bmhsc.org)
Beebe Health Campus Rehoboth Beach, Delaware - (research@beebehealthcare.org)
Beebe South Coastal Health Campus Millville, Delaware - (research@beebehealthcare.org)
Benefis Sletten Cancer Institute Great Falls, Montana - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana - (research@billingsclinic.org)
Blanchard Valley Hospital Findlay, Ohio - (clinical.trials@daytonncorp.org)
Bozeman Health Deaconess Hospital Bozeman, Montana - (mccinfo@mtcancer.org)
Broadlawns Medical Center Des Moines, Iowa
Bronson Battle Creek Battle Creek, Michigan - (crcwm-regulatory@crcwm.org)
CHI Health Good Samaritan Kearney, Nebraska - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Care Center of O'Fallon O'Fallon, Illinois - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Hematology Centers - Flint Flint, Michigan - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois - (Research@carle.com)
Carle Cancer Institute Normal Normal, Illinois - (Research@Carle.com)
Carle Physician Group-Effingham Effingham, Illinois - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois - (Research@carle.com)
Carle at The Riverfront Danville, Illinois - (Research@Carle.com)
CaroMont Health - Lincoln Cancer Center Lincolnton, North Carolina
CaroMont Regional Medical Center Gastonia, North Carolina - (tammy.cozad@caromonthealth.org)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centra Alan B Pearson Regional Cancer Center Lynchburg, Virginia - (Kevin.Patel@centrahealth.com)
CentraState Medical Center Freehold, New Jersey
Central Vermont Medical Center Berlin Corners, Vermont
Centralia Oncology Clinic Centralia, Illinois - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, - (dcuadrado@cccupr.org)
Chilton Medical Center Pompton, New Jersey
Christiana Care - Union Hospital Elkton, Maryland - (frank.crum@christianacare.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota - (coborncancercenter@centracare.com)
Colorado Blood Cancer Institute Denver, Colorado - (info@westernstatesncorp.org)
Community Hospital of Anaconda Anaconda, Montana - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana - (HemonCCTrials@geisinger.edu)
Condell Memorial Hospital Libertyville, Illinois - (advocateresearch@advocatehealth.com)
Cone Health Cancer Center Greensboro, North Carolina - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Alamance Regional Burlington, North Carolina - (stacey.phelps@conehealth.com)
Cone Health Cancer Center at Drawbridge Parkway Greensboro, North Carolina - (stacey.phelps@conehealth.com)
Cone Health MedCenter Asheboro Asheboro, North Carolina - (stacey.phelps@conehealth.com)
Contra Costa Regional Medical Center Martinez, California
Contra Costa Regional Medical Center Martinez, California
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan - (crcwm-regulatory@crcwm.org)
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Cox Health South Hospital Springfield, Missouri
CoxHealth South Hospital Springfield, Missouri
Crossroads Cancer Center Effingham, Illinois - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC - Englewood Dayton, Ohio - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois - (morganthaler.jodi@mhsil.com)
Doctors Cancer Center Manati,
Duluth Clinic Ashland Ashland, Wisconsin - (CancerTrials@EssentiaHealth.org)
Edwards Comprehensive Cancer Center Huntington, West Virginia - (Christina.Cole@chhi.org)
Englewood Hospital and Medical Center Englewood, New Jersey
Ephrata Cancer Center Ephrata, Pennsylvania
Essentia Health - Deer River Clinic Deer River, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health - Fosston Fosston, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health - Park Rapids Park Rapids, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin - (CancerTrials@EssentiaHealth.org)
Fairbanks Memorial Hospital Fairbanks, Alaska - (Veronica.Stevenson@foundationhealth.org)
Fairview Northland Medical Center Princeton, Minnesota - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky - (ResearchInstituteInquiries@CommonSpirit.org)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania - (hemoncctrials@geisinger.edu)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan - (wstrong@ghci.org)
Gibbs Cancer Center-Gaffney Gaffney, South Carolina - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina - (kmertz-rivera@gibbscc.org)
Glens Falls Hospital Glens Falls, New York Misty J DeCaro - (lacrosmj@glensfallshosp.org)
Greater Dayton Cancer Center Kettering, Ohio - (clinical.trials@daytonncorp.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois - (morganthaler.jodi@mhsil.com)
Hackettstown Medical Center Hackettstown, New Jersey
Harold Alfond Center for Cancer Care Augusta, Maine
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii - (i.webster@hawaiicancercare.com)
HaysMed Hays, Kansas
Hayworth Cancer Center High Point, North Carolina
Heartland Regional Medical Center Saint Joseph, Missouri - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware - (lbarone@christianacare.org)
Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia - (cvaughn@hoafredericksburg.com)
Hennepin County Medical Center Minneapolis, Minnesota - (mmcorc@healthpartners.com)
Hi-Line Sletten Cancer Center Havre, Montana - (mccinfo@mtcancer.org)
Holy Name Hospital Teaneck, New Jersey
Illinois CancerCare - Washington Washington, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois - (andersonj@illinoiscancercare.com)
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NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Trial info - trialinfo@nspharma.com

NCT05996003
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Inclusion Criteria:
* Male ≥ 4 years and \<15 years of age * Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame * Able to walk independently without assistive devices * Ability to complete the TTSTAND without assistance in \<20 seconds * Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study. * Other inclusion criteria may apply.
Exclusion Criteria:
* Has a body weight of \<20 kg at the time of informed consent (applies to participants screening for Part 1 only) * Evidence of symptomatic cardiomyopathy * Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug * Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer * Surgery within the 3 months prior to the first dose of study drug or planned during the study duration * Previously treated in an interventional study of NS-089/NCNP-02 * Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP * Other exclusion criteria may apply.
DRUG: NS-089/NCNP-02
Duchenne Muscular Dystrophy, Exon 44, DMD
Exon 44 Skipping, DMD, Brogidirsen
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Study Locations

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Location Contacts
Alberta Children's Hospital Calgary, Alberta Julie Dao - (julie.dao@ucalgary.ca)
Ankara Bilkent City Hospital Ankara, Gozde Akgun - (gozde.akgun@medex-smo.com)
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Raven Hill - (rhill@luriechildrens.org) Alka Maheshwari - (amaheshwari@luriechildrens.org)
British Columbia Children's Hospital Vancouver, British Columbia Gabe Massarotto - (gabe.massarotto@cw.bc.ca)
Children's Hospital Colorado Aurora, Colorado Hannah Kleiner - (hannah.kleiner@childrenscolorado.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Angela Edmondson - (Angela.Edmondson@cchmc.org)
Fukui Prefectural Hospital Fukui-shi, Fukui
London Health Sciences Centre London, Ontario Rhiannon Hicks - (rhiannon.hicks@lhsc.on.ca)
NHO Osaka Toneyama Medical Center Toyonaka, Osaka Clinical Trial Office - (410-chiken@mail.hosp.go.jp)
National Center of Neurology and Psychiatry Tokyo,
National Hospital Organization Nagara Medical Center Nagara, Gifu-shi, Gifu Clinical Trial Management Office - (yonekura.kei.wu@mail.hosp.go.jp)
Perth Children's Hospital Perth, Western Australia Jane Jones - (Jane.Jones2@health.wa.gov.au)
Pusan National University Yangsan Hospital Yangsan, JaeYoon Kim - (lusterwuzz@naver.com)
Rare Disease Research Atlanta, Georgia Julia Zhu - (julia.zhu@rarediseaseresearch.com)
Rare Disease Research, LLC - FL Kissimmee, Florida Marcial Almaraz - (marcial.almaraz@rarediseaseresearch.com)
S.B.U. Dr. Behcet uz Pediatric Diseases and Surgery Training and Research Hospital Izmir, Zeynep Erturk - (zeyneperturk@ascotscience.com)
Seoul National University Hospital Seoul, Hyeon Ju Kwon - (hjkwon@snuh.org; 49041@snuh.org)
Shiga General Hospital Moriyama, Children's Building - (kenji.s.address@gmail.com)
Starship Children's Hospital Grafton, Auckland Margaret Joppa - (mjoppa@adhb.govt.nz)
The Children's Hospital of Philadelphia (CHOP) Philadelphia, Pennsylvania Karen Monono - (mononok@email.chop.edu)
UT Southwestern/Children's Health Dallas, Texas Deniece Winston - (Deniece.Winston@UTSouthwestern.edu)
University of Kansas Medical Center (KUMC) Kansas City, Kansas Rebecca Clay - (rclay@kumc.edu)
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania Vibha Chauhan - (vibha.chauhan@chp.edu)
Virginia Commonwealth University Health System Richmond, Virginia Andrea Jewell - (andrea.jewell@vcuhealth.org)
Yeditepe University Kosuyolu Hospital Istanbul, Onur Güner - (onurguner@ascotscience.com)

Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer (SUNRAY-02)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

NCT06890598
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Inclusion Criteria:
* Histological or cytological confirmation of NSCLC. * Part A
• Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
• Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection. * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy. * Must have disease with evidence of KRAS G12C mutation. * Must have known programmed death-ligand 1 (PD-L1) expression * Must have an ECOG performance status of 0 or 1. * Able to swallow oral medication. * Must have adequate laboratory parameters. * Contraceptive use should be consistent with local regulations for those participating in clinical studies. * Women of childbearing potential must * Have a negative pregnancy test. * Not be breastfeeding during treatment
Exclusion Criteria:
* Have known, actionable changes in the EGFR or ALK genes. * Have another type of cancer that is progressing or required active treatment within the past 2 years before screening. * Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed. * Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.
DRUG: Olomorasib, DRUG: Pembrolizumab, DRUG: Durvalumab, DRUG: Placebo
Carcinoma, Non-Small-Cell Lung
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Study Locations

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Location Contacts
AHN Allegheny General Hospital Pittsburgh, Pennsylvania
ASST Grande Ospedale Metropolitano Niguarda Milan,
AZ Delta vzw Roeselare, West-Vlaanderen
Adana City Hospital Adana,
Agios Loukas Clinic Thessaloniki,
Agios Savvas Regional Cancer Hospital Athens,
Aichi Cancer Center Hospital Nagoya,
Amphia Ziekenhuis, locatie Breda Molengracht Breda,
Amsterdam UMC, locatie VUmc Amsterdam,
Antalya Egitim ve Arastırma Hastanesi Antalya,
Antwerp University Hospital Edegem,
Anyang Cancer Hospital Anyang,
Asan Medical Center Seoul,
Asklepios Fachkliniken München-Gauting Gauting,
Asklepios Klinik Harburg Hamburg,
Assistance Publique Hopitaux de Marseille - Hopital Nord Marseille,
Aultman Hospital Canton, Ohio
Austin Health Heidelberg,
Avera Cancer Institute- Research Sioux Falls, South Dakota
Azienda Ospedaliera Dei Colli Naples,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona,
Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano,
BASS Cancer Center Walnut Creek, California
Baptist Health Hamburg Lexington, Kentucky
Baptist Health Lexington Lexington, Kentucky
Baskent University Dr. Turgut Noyan Research and Training Center Adana,
Beijing Cancer Hospital Beijing,
Boca Raton Regional Hospital Boca Raton, Florida
Bradfordhill Santiago,
Budapesti Uzsoki Utcai Korhaz Budapest,
Buddhist Dalin Tzu Chi General Hospital Chiayi City,
CHI Saint Joseph Cancer Center - East Lexington, Kentucky
CHIREC - site delta Auderghem,
CHU Bordeaux Haut-Leveque Pessac, Aquitaine
CHU Grenoble Alpes La Tronche,
CHU de Toulouse - Hopital Larrey Toulouse, Haute-Garonne
CHUS - Hospital Clinico Universitario Santiago de Compostela,
CTO - Centro de Tratamento Oncológico Belém,
Cancer Care Northwest - Vercler Spokane Valley, Washington
Cancer Hospital Chinese Academy of Medical Science Beijing,
Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center Shenzhen,
Cancer Hospital of Shantou University Medical College Shantou,
Captain James A. Lovell Federal Health Care Center North Chicago, Illinois
Centre Antoine-Lacassagne Nice,
Centre Hospitalier Universitaire de Poitiers Poitiers,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes,
Centre Leon Berard Lyon,
Centro Hospitalar E Universitário De Coimbra Coimbra,
Centro Paulista de Oncologia Clínica São Paulo,
Centro de Oncología de Precisión Santiago,
Centro de Pesquisa Clínica do Instituto do Câncer do Ceará Fortaleza,
Centro de Pesquisa Sao Lucas Campinas, São Paulo
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA Rio de Janeiro,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist,
Changhua Christian Hospital Changhua County,
Charite Campus Virchow-Klinikum Berlin,
Chi Mei Hospital - Liouying Branch Tainan, Tainan
Chi Mei Medical Center Tainan,
China-Japan Friendship Hospital Beijing,
Chonnam National University Hwasun Hospital Hwasun,
Chung Shan Medical University Hospital Taichung,
Chungbuk National University Hospital Cheongju-si,
City of Hope National Medical Center, Atlanta Cancer Center Newnan, Georgia
City of Hope, Chicago Chicago, Illinois
City of Hope, Phoenix Phoenix, Arizona
Clearview Cancer Institute Huntsville, Alabama
Cleveland Clinic Cleveland, Ohio
Cleveland Clinic - Hillcrest Hospital Mayfield Heights, Ohio
Columbia University Irving Medical Center New York, New York
Complejo Hospitalario de Navarra Pamplona,
Comprehensive Hematology Oncology St. Petersburg, Florida
DRK Kliniken Berlin Mitte Berlin,
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire
Deenanath Mangeshkar Hospital & Research Centre Pune,
Drammen Sykehus, Vestre Viken HF Drammen,
E-DA Hospital Kaohsiung City,
ETZ Elisabeth Tilburg,
Errikos Dunant Hospital Center Athens, Attikí
European Interbalkan Medical Center Thessaloniki,
Evangelische Lungenklinik Berlin Berlin,
Evangelisches Krankenhaus Herne - Eickel Herne,
FALP Santiago,
Fairview Hospital Cleveland, Ohio
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica Banská Bystrica, Banská Bystrica Region
Fakultni nemocnice Bulovka Prague,
Far Eastern Memorial Hospital New Taipei City, NEW Taipei
Farkasgyepui Tudogyogyintezet Farkasgyepű, Veszprém megye
Florida Cancer Specialists - South Fort Myers, Florida
Florida Cancer Specialists East West Palm Beach, Florida
Florida Cancer Specialists North St. Petersburg, Florida
Franciscan Health Indianapolis, Indiana
Franziskus-Hospital Harderberg Georgsmarienhütte,
Fudan University Shanghai Cancer Center Shanghai,
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo
Galaxy Superspeciality Hospital Aurangabad,
Gangnam Severance Hospital, Yonsei University Health System Gangnam-gu,
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep,
Goulburn Valley Health Shepparton,
Groupe hospitalier Paris saint Joseph Paris, Île-de-France Region
Guangdong Provincial People's Hospital Guangzhou,
Guangxi Medical University Affiliated Tumor Hospital Nanning,
Gustave Roussy Villejuif,
H.R.U Málaga - Hospital General Málaga,
HELIOS Klinikum Erfurt Erfurt,
HFR Fribourg - Hôpital cantonal Fribourg,
Harbin Medical University Cancer Hospital Ha’erbin,
Hartford Hospital (HH) Hartford, Connecticut
Haukeland Universitetssjukehus Bergen,
Heartlands Hospital Birmingham,
Hemato Oncology Clinic Ahmedabad,
Highlands Oncology Group Springdale, Arkansas
Himeji Medical Center Himeji,
Hokkaido University Hospital Sapporo, Hokkaido
Hospices Civils de Lyon - Hopital Louis Pradel Bron, Rhône
Hospital Clinic de Barcelona Barcelona,
Hospital Clinico Universitario Lozano Blesa Zaragoza,
Hospital Clinico de Valencia Valencia,
Hospital Cuf porto Porto,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Infanta Cristina Badajoz,
Hospital Insular de Gran Canaria Las Palmas de Gran Canaria,
Hospital Jerez de la Frontera Jerez de la Frontera,
Hospital Santa Catarina - Paulista São Paulo,
Hospital Sao Lucas da PUCRS Porto Alegre,
Hospital Sirio Libanes São Paulo,
Hospital Tacchini Bento Gonçalves,
Hospital Universitari Son Espases Palma,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario 12 de Octubre Madrid, Madrid, Comunidad de
Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón,
Hospital Universitario Ramon y Cajal Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hospital da Luz Lisboa Lisbon,
Hospital de Cancer de Londrina Londrina,
Houston Methodist Hospital Houston, Texas
Hualien Tzu Chi Medical Center Hualien City,
Hubei Cancer Hospital Wuhan,
Huddersfield Royal Infirmary Huddersfield,
Hunan Cancer Hospital Changsha,
Hunan Cancer Hospital Changsha,
Hôpital Européen Georges Pompidou Paris,
Hôpital Robert Schuman Vantoux,
ICON Cancer Centre - Kurralta Park Kurralta Park,
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Icon Cancer Centre Wesley Auchenflower,
Infirmary Cancer Care Mobile, Alabama
Institut Curie Paris,
Institut Jean Godinot Reims,
Instituto Catalan de Oncologia - Hospital Duran i Reynals Hospitalet,
Instituto D'Or Pesquisa e Ensino Rio de Janeiro,
Instituto D'Or de Pesquisa e Ensino (IDOR) São Paulo,
Instituto Português de Oncologia do Porto Francisco Gentil, EPE Porto,
Instituto Tumori Giovanni Paolo II Bari,
Institutul Oncologic Cluj-Napoca,
Isala, locatie Zwolle Zwolle,
Istituto Nazionale Tumori Regina Elena Rome,
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola,
Izmir Atatürk Training and Research Hospital Izmir,
James M Stockman Cancer Institute Frederick, Maryland
Jefferson Health - Cherry Hill Cherry Hill, New Jersey
Jefferson Hospital Northeast Philadelphia, Pennsylvania
Jilin Province Tumor Hospital Changchun,
Jinan Central Hospital Jinan,
Johns Hopkins Bayview Medical Center Baltimore, Maryland
Juntendo University Hospital Bunkyō City,
K2 Oncology Providencia,
Kaiser Permanente Interstate Medical Office Central Portland, Oregon
Kaiser Permanente San Diego Mission Road San Diego, California
Kanagawa Cancer Center Yokohama,
Kanagawa Cardiovascular and Respiratory Center Yokohama,
Kanazawa University Hospital Kanazawa,
Kansai Medical University Hospital Hirakata,
Kantonsspital Baden Baden, Canton of Aargau
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karmanos Cancer Institute Detroit, Michigan
Keimyung University Dongsan Hospital Daegu,
Kelsey-Seybold Clinic Houston, Texas
Kindai University Hospital- Osakasayama Campus Sakai,
Klinik Floridsdorf Vienna,
Klinikum Chemnitz Chemnitz,
Klinikum Nürnberg Nord Nuremberg,
Konkuk University Medical Center Seoul,
Korea University Guro Hospital Seoul, Guro-gu
Kouros Moccia Oncologia Locarno,
Krankenhaus Martha-Maria Halle-Dölau Halle,
Kyungpook National University Chilgok Hospital Daegu,
Kyushu University Hospital Fukuoka,
Lahey Hospital & Medical Center Burlington, Massachusetts
Latrobe Regional Health Traralgon,
Lexington Medical Center West Columbia, South Carolina
Liga Norte Riograndense Contra O Cancer Natal,
Liuzhou People's Hospital Liuzhou,
Lotus-Med Bucharest,
LungenClinic Grosshansdorf Großhansdorf,
Lungenklinik Hemer Hemer,
MV-Zentrum für Onkologie und Hämatologie Cologne,
Maastricht UMC+ Maastricht,
Malabar Cancer Centre - Thalassery Thalassery,
Marmara Universitesi Pendik Egitim Arastirma Hastanesi Pendik,
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana
Medical College of Wisconsin Milwaukee, Wisconsin
Medical University of South Carolina Charleston, South Carolina
Medipoint Hospitals Pvt. Ltd. Pune,
Medizinische Universität Graz Graz, Styria
Meir Medical Center Kfar Saba, Central District
Memorial Sloan Kettering Cancer Center New York, New York
Miami Cancer Institute at Baptist Health, Inc. Miami, Florida
Miami Valley Hospital South Centerville, Ohio
Missouri Baptist Medical Center St Louis, Missouri
Miyagi Cancer Center Natori,
Moffitt Cancer Center Tampa, Florida
NHO Kinki Chuo Chest Medical Center Sakai,
National Cancer Center Goyang-si, Gyeonggi-do
National Cancer Center Hospital East Kashiwa,
National Cheng Kung University Hospital Tainan,
National Taiwan University Cancer Center (NTUCC) Taipei,
National Taiwan University Hospital Taipei,
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region Douliu,
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) Amsterdam,
Nemocnice AGEL Ostrava - Vitkovice a.s. Ostrava,
New England Cancer Specialists Westbrook, Maine
New Taipei Municipal TuCheng Hospital New Taipei City,
Niigata Cancer Center Hospital Niigata,
Northport VA Medical Center Northport, New York
Northwest Cancer Specialists PC Vancouver, Washington
Northwestern Memorial Hospital Chicago, Illinois
OSF Saint Francis Medical Center Peoria, Illinois
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala Ocala, Florida
Ochsner Clinic Foundation New Orleans, Louisiana
Ochsner Health Ochsner Cancer Center - Baton Rouge Baton Rouge, Louisiana
OhioHealth Riverside Methodist Hospital Columbus, Ohio
Oncocentro de Minas Gerais Belo Horizonte,
One Day Med Szczecin,
Onkologiezentrum Donauwörth Donauwörth,
Ordensklinikum Linz GmbH Elisabethinen Linz,
Oregon Health and Science University Portland, Oregon
Orszagos Onkologiai Intezet Budapest,
Oslo universitetssykehus, Radiumhospitalet Oslo,
Ospedale San Gerardo-ASST Monza Monza,
Ospedale San Martino Genova,
Ovidius Clinical Hospital OCH Ovidiu,
Pacific Medical College & Hospital Udaipur,
Parc de Salut Mar - Hospital del Mar Barcelona,
Parkview Research Center at Parkview Regional Medical Center Fort Wayne, Indiana
Peking University People's Hospital Beijing,
Policlinico "G. Rodolico" Catania,
Profound Research LLC Oceanside, California
Providence Portland Medical Center Portland, Oregon
Providence St. Vincent Medical Center Portland, Oregon
Pusan National University Hospital Busan,
Pusan National University Yangsan Hospital Yangsan,
Rajiv Gandhi Government General Hospital Chennai,
Rambam Health Care Campus Haifa,
Regional Cancer Centre - Thiruvananthapuram Thiruvananthapuram,
Reliant Medical Group Worcester, Massachusetts
Robert Bosch Krankenhaus GmbH Stuttgart, Baden-Wurttemberg
Royal Marsden Hospital (Chelsea) London,
Royal Marsden Hospital (Sutton) Sutton,
SC Memorial Healthcare International SRL Bucharest,
SCRI Oncology Partners Nashville, Tennessee
Sahlgrenska Universitetssjukhuset Gothenburg,
Saitama Medical University International Medical Center Hidaka,
Sakarya University School of Medicine Adapazarı,
Samsun Medical Park Hastanesi Samsun,
Samsung Medical Center Seoul,
Sarah Cannon Research Institute Denver, Colorado
Savera Cancer & Multi Speciality Hospital Patna,
Seoul National University Bundang Hospital Seongnam, Kyeonggi-do
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
Shandong Cancer Hospital Jinan,
Shanghai Chest Hospital Shanghai,
Sheba Medical Center Ramat Gan,
Shenzhen People's Hospital Shenzhen,
Shizuoka Cancer Center Sunto Gun,
Sibley Memorial Hospital Washington D.C., District of Columbia
Sichuan Cancer Hospital Chengdu, Sichuan
Sidney Kimmel Cancer Center - Washington Township Sewell, New Jersey
Sir Charles Gairdner Hospital Nedlands,
Sir H. N. Reliance Foundation Hospital and Research Centre Mumbai,
Sorlandet Sykehus Arendal Arendal,
Springfield Clinic Main Campus Springfield, Illinois
St. Antonius Ziekenhuis, locatie Utrecht Utrecht,
St. Elisabeth-Krankenhaus Leipzig Leipzig,
Stanford Cancer Center Palo Alto, California
Sunshine Coast University Hospital Birtinya,
Swedish Cancer Institute - Edmonds Edmonds, Washington
Swedish Medical Center Englewood, Colorado
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej Kielce,
Sykehuset Innlandet HF Gjøvik Gjøvik,
Taichung Veterans General Hospital Taichung,
Taipei Medical University Hospital Taipei,
Taipei Veterans General Hospital Taipei,
Taizhou Hospital of Zhejiang Province Zhejiang,
Tamworth Hospital North Tamworth,
Tata Memorial Centre - Homi Bhabha Cancer Hospital Varanasi,
Tennessee Oncology Nashville, Tennessee
Tennessee Oncology Chattanooga Chattanooga, Tennessee
Thangam Cancer Center - Namakkal Namakkal,
The Cancer Institute Hospital of JFCR Koto-ku, Tokyo
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul,
The Catholic University Of Korea St. Vincent's Hospital Suwon,
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul,
The Catholic University of Korea, Incheon St. Mary's Hospital Bupyeong-gu,
The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul,
The Center for Cancer and Blood Disorders Fort Worth, Texas
The Christie NHS Foundation Trust Manchester, Lancashire
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The First Affiliated Hospital of Henan University of Science &Technology Luoyang,
The First Affiliated Hospital of Soochow University Suzhou,
The First Affiliated Hospital of Xi'An Jiaotong University Xi'an,
The First People's Hospital of Foshan Foshan,
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer -T Columbus, Ohio
The Second Affiliated Hospital Chongqing Medical University Chongqing,
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou,
The Second People's Hospital of Neijiang Neijiang,
The Third People's Hospital of Chengdu (CDTPH) Chengdu,
The University of Arizona Cancer Center - North Campus Tucson, Arizona
The University of Vermont Medical Center Inc. Burlington, Vermont
Thomas Jefferson University, Sidney Kimmel Cancer Center - Clinical Trials Office Philadelphia, Pennsylvania
Thoracic General Hospital of Athens "I Sotiria" Athens, Attikí
Thoraxklinik-Heidelberg gGmbH Heidelberg,
Tianjin Medical University Cancer Institute & Hospital Tianjin,
Tianjin Medical University Cancer Institute & Hospital Tianjin,
Tokyo Metropolitan Komagome Hospital Bunkyō City,
Tongji Hospital Tongji Medical,Science & Technology Wuhan,
Torbay Hospital Torquay,
Tottori University Hospital Yonago,
Trakya University Edirne,
UCLA Hematology/Oncology - Santa Monica Los Angeles, California
USO - Texas Oncology - San Antonio San Antonio, Texas
USO - Texas Oncology Gulf Coast Sugar Land, Texas
USO - US Oncology Research Network The Woodlands, Texas
UZ Leuven Leuven,
Universitaetsklinikum Tuebingen Tübingen,
University General Hospital of Heraklion Irakleio,
University General Hospital of Larissa Larissa,
University Hospital and UW Health Clinics Madison, Wisconsin
University Hospital of Patras Pátrai, Achaḯa
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University Hospitals Sussex NHS Foundation Trust East Sussex,
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange, California
University of Chicago Medical Center Chicago, Illinois
University of Florida - Jacksonville Jacksonville, Florida
University of Health Sciences,Gulhane School of Medicine Ankara,
University of Illinois at Chicago Chicago, Illinois
University of Maryland Baltimore, Maryland
University of Tennessee Medical Center Knoxville, Tennessee
University of Texas MD Anderson Cancer Center Houston, Texas
University of Virginia Health System Charlottesville, Virginia
Univerzitná nemocnica Bratislava - Nemocnica Ružinov Bratislava,
VCU Health Adult Outpatient Pavillion Richmond, Virginia
Vivantes Klinikum im Friedrichshain - Landsberger Allee Berlin,
Vychodoslovensky Onkologicky ustav a.s. Košice,
Wakayama Medical University Hospital Wakayama,
WakeMed Raleigh Campus Raleigh, North Carolina
West China Hospital, Sichuan University Chengdu,
Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan,
Winship Cancer Institute Atlanta, Georgia
Xiangya Hospital Central South University Changsha,
Yeungnam Univeristy Medical Center Nam-gu,
Zhejiang Cancer Hospital Hangzhou,
Zhejiang Cancer Hospital Hangzhou,
Zhejiang Provincial People's Hospital Hangzhou,
Zhongshan Peoples Hospital Zhongshan,
ZhuZhou Central Hospital Zhuzhou,
Ziekenhuis St. Jansdal Harderwijk,
İ.A.Ü VM Medical Park Florya Hastanesi Istanbul,

Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)

ctrrecruit@vcu.edu

NCT06577441
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Inclusion Criteria:
* GENERAL MYLEOMATCH REGISTRATION CRITERIA: * Patients must be registered to the Master Screening and Reassessment Protocol (MYELOMATCH) and assigned to this protocol by the MATCHBox Treatment Verification Team. * Participants must not have received prior anti-cancer therapy for AML or MDS. * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed. * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. * Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g/m\^2 of cytarabine, which is allowed for urgent cytoreduction. The use of prior hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide is allowed * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a morphologically-confirmed diagnosis of MDS with a Revised International Prognostic Scoring System (IPSS-R) score ≥ 4. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients must have a detectable pathogenic IDH2 mutation based on the National Cancer Institute (NCI) Myeloid Panel. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior treatment with deoxyribonucleic acid (DNA) methyltransferase inhibitors (ASTX727, azacitidine, or decitabine). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with growth factors (ESA, granulocyte colony-stimulating factor \[g-CSF\], thrombopoietin \[TPO\] agonist) or luspatercept is allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Prior treatment with lenalidomide with a maximum limit of 1 month of exposure is allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with therapy-related MDS are allowed. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age ≥ 18 years. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome, if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) ≤ 3.0 x upper limit of normal (ULN). * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects. * Therefore, for women of childbearing potential only, a negative pregnancy test done as part of screening lab work prior to registration is required. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. * REGISTRATION ELIGIBILITY CRITERIA (STEP 1): 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. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients on the ASTX727 monotherapy arm (Regimen 1) that do not achieve a CR (complete response), CRL (CR with limited count recovery), or CRh (CR with partial count recovery) after completing 6 cycles of study treatment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status ≤ 2. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Total bilirubin ≤ 1.5 x upper limit of normal (ULN). * Unless elevated due to Gilbert's syndrome. In patients with Gilbert's syndrome if the total bilirubin is ≤ 3.0 x ULN, then they are eligible for enrollment. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST (SGOT)/ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN) * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Creatinine clearance ≥ 30 mL/min * To be calculated using Cockroft Gault formula. * RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Not pregnant and not nursing, because this study involves: an agent that has known genotoxic, mutagenic and teratogenic effects.
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Decitabine and Cedazuridine, DRUG: Enasidenib
Myelodysplastic Syndrome
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Location Contacts
Alta Bates Summit Medical Center-Herrick Campus Berkeley, California
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)
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 Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.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)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ctsucontact@westat.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Cooperman Barnabas Medical Center Livingston, New Jersey
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)
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)
Edward Hines Jr VA Hospital Hines, Illinois
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 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 Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Genesee Hematology Oncology PC Flint, Michigan
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
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)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.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)
Iowa Methodist Medical Center Des Moines, Iowa
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)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Marshfield Medical Center - Weston Weston, 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)
Medical College of Wisconsin Milwaukee, Wisconsin
Memorial Hospital West Pembroke Pines, Florida
Mercy Medical Center - Des Moines Des Moines, Iowa
Miami Cancer Institute Miami, Florida
Mills Health Center San Mateo, California
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)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
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)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Our Lady of The Lake Baton Rouge, Louisiana
Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Parkland Health Center - Farmington Farmington, Missouri
Phoebe Putney Memorial Hospital Albany, Georgia Site Public Contact - (ga_cares@augusta.edu)
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)
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-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
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 Vincent Hospital Cancer Center Green Bay Green Bay, 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)
Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
San Juan City Hospital San Juan,
Southern Illinois University School of Medicine Springfield, Illinois
Springfield Clinic Springfield, Illinois
Springfield Memorial Hospital Springfield, Illinois Site Public Contact - (pallante.beth@mhsil.com)
Stony Brook University Medical Center Stony Brook, New York
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-First Hill Seattle, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
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 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)
Tufts Medical Center Boston, Massachusetts Site Public Contact - (ContactUsCancerCenter@TuftsMedicalCenter.org)
UC Comprehensive Cancer Center at Silver Cross New Lenox, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
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)
UChicago Medicine Northwest Indiana Crown Point, Indiana Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
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
UI Healthcare Mission Cancer and Blood - Pella Pella, Iowa Site Public Contact - (trials@missioncancer.com)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania
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 Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Clinical Research Center Fairway, 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 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 Tennessee - Knoxville Knoxville, Tennessee
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Walter Reed National Military Medical Center Bethesda, Maryland
William S Middleton VA Medical Center Madison, Wisconsin

Vitamin D for Prostate Endocrine Therapy (ViPER)

Brooke Burgess, MS - URCC_22053@urmc.rochester.edu

NCT05838716
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Inclusion Criteria:
* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed) * Be age 50 years or older * Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted) * Have a total serum vitamin D between 10 and 32 ng/ml * Have a total serum calcium of less than or equal to 10.5 mg/dl * Have a normal GFR (glomerular filtration rate \> 30ml) * Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study * Be able to provide written informed consent * Be able to swallow pills and capsules * Be able to speak and read English
Exclusion Criteria:
* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment * Have a diagnosis of stage IV chronic kidney disease * Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl) * Have a history of hypercalcemia or vitamin D toxicity/sensitivity
PROCEDURE: Biospecimen Collection, DIETARY_SUPPLEMENT: D Vitamin, PROCEDURE: Dual X-ray Absorptiometry, DRUG: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
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Study Locations

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Location Contacts
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Ballad Health Cancer Care - Bristol Bristol, Virginia Site Public Contact - (charles.mays@balladhealth.org)
Ballad Health Cancer Care - Kingsport Kingsport, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia Site Public Contact - (Anne_caramella@bshsi.org)
Bon Secours Memorial Regional Medical Center Mechanicsville, 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)
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)
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)
CarolinaEast Medical Center New Bern, North Carolina Site Public Contact - (lharrison@carolinaeasthealth.com)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Cancer Center Dickson City Dickson City, 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 Site Public Contact - (kmertz-rivera@gibbscc.org)
Gibbs Cancer Center-Pelham Greer, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Saint Louis St Louis, Missouri
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Nash UNC HealthCare Rocky Mount, North Carolina
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee Site Public Contact - (charles.mays@balladhealth.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
SMC Center for Hematology Oncology Union Union, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Saint Francis Cancer Center Colorado Springs, Colorado Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Federal Way, Washington Site Public Contact - (Heather_Rich@bshsi.org)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, 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)
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
University Medical Center New Orleans New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
University of Kansas Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center - North Kansas City, Missouri Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Cancer Center-Overland Park Overland Park, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Health System Saint Francis Campus Topeka, Kansas Site Public Contact - (KUCC_Navigation@kumc.edu)
University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas Site Public Contact - (KUCC_Navigation@kumc.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)

A Virtual Reality Brief Violence Intervention: Preventing Gun Violence Among Violently Injured Adults

Nicholas Thomson - Nicholas.thomson@vcuhealth.org

NCT06239285
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Inclusion Criteria:
* violently injured patients from VCU's Level 1 Trauma Center * 18 years or older * English-speaking
Exclusion Criteria:
* Under 18 years old * Not a victim of Violent crime
DEVICE: Brief Violence Intervention VR (BVI-VR), OTHER: Treatment as Usual (TAU)
Violence
Firearm Violence Victim
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Virginia Commonwealth University Richmond, Virginia Nicholas Thomson - (nicholas.thomson@vcuhealth.org)

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (SOHO-02)

Bayer Clinical Trials Contact - clinical-trials-contact@bayer.com

NCT06452277
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Inclusion Criteria:
* Participant must be ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signing the informed consent. * Documented histologically or cytologically confirmed locally advanced non-squamous NSCLC, not suitable for definitive therapy or metastatic non-squamous NSCLC at screening (small cell or mixed histologies are excluded) (Stage III-IV NSCLC). * Documented activating HER2 mutation in the tyrosine kinase domain (TKD) assessed by tissue molecular test in a CLIA-certified (US sites) or an equally accredited (outside of the US) local laboratory. However, participants may be included at the discretion of the investigator if the laboratory performing the assay is not CLIA or similar certified but the laboratory is locally accredited. * No prior systemic therapy for locally advanced or metastatic disease. No prior treatment with a HER2 ex20ins-targeted therapy (e.g. poziotinib, trastuzumab deruxtecan). Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the start of screening. * Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the SmPC/Product Information.
Exclusion Criteria:
* Known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for five years since initiation of that therapy. Exception: the following cancer types are acceptable within five years if curatively treated or under surveillance: * a. in situ cancers of cervix, breast, or skin, * b. superficial bladder cancer (Ta, Tis and T1), * c. limited-stage prostate cancer, * d. basal or squamous cancers of the skin. * Tumors with targetable alterations with approved available therapy, with the exception of HER2 mutation in the TKD. * Inability to discontinue treatment with chronic systemic corticosteroids. Participants who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is acceptable, provided that the dose is stable for \>4 weeks prior to planned start of study intervention. * Pre-existing peripheral neuropathy that is Grade ≥2 by CTCAE (v5.0). * History of severe hypersensitivity reaction to treatment with a monoclonal antibody. * Prior radiotherapy outside of the brain within 21 days before of planned start of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
DRUG: Sevabertinib, DRUG: Pembrolizumab, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed
Advanced Non-small Cell Lung Cancer, HER2 Mutation
NSCLC, ERBB2 mutation, HER2 mutation
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Study Locations

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Location Contacts
?enry Dunant Hospital Center-4th Oncology Department and Clinical Trials Unit Athens,
A Beneficencia Portuguesa de Sao Paulo - Hospital BP Mirante São Paulo, São Paulo
AORN San Giuseppe Moscati Avellino - U.O.C. Oncologia Medica Avellino, Campania
ASST Sette Laghi_Ospedale Macchi - Oncologia Varese,
AZ Delta | Clinical Trial Center - Pneumology Roeselare, West Flanders
Aalborg University hospital - oncology department Aalborg, North Denmark
Aarhus Universitetshospital Aarhus,
Adana Sehir Egitim ve Arastirma Hastanesi Adana,
AdventHealth Cancer Institute Orlando Orlando, Florida
Allegheny General Hospital Pittsburgh, Pennsylvania
Ankara Bilkent Sehir Hastanesi Ankara,
Ankara Etlik Sehir Hastanesi Ankara,
Antwerp University Hospital | Oncology Department Antwerp, Antwerp
Assuta Ashdod Public Hospital (R.A) Ashdod,
Austin Hospital - Olivia Newton John Cancer Research Institute Heidelberg, Victoria
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello - Oncologia Medica Palermo,
Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola - UOC Oncologia Medica Bologna, Emilia-Romagna
Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Oncologia Medica Orbassano, Piedmont
BC Cancer | Vancouver Vancouver, British Columbia
Beacon Hospital Dublin, Co Dublin
Beijing Cancer Hospital - Oncology Department Beijing, Beijing Municipality
Beijing Chest Hospital, Capital Medical University Beijing, Beijing Municipality
Beijing Hospital Beijing,
Belfast City Hospital Belfast, Northern Ireland
Brampton Civic Hospital | Oncology Brampton, Ontario
Budapesti Uzsoki Utcai Korhaz - Tüdogyógyászati Osztály Budapest,
CHU Montpellier - Hopital Arnaud de Villeneuve - Service oncologie thoracique Montpellier, Occitanie
CHU de Rouen - Hopital Charles Nicolle - Service de Pneumologie Rouen, Normandy
CHULN - Hospital Pulido Valente Lisbon,
Calvary Mater Hospital Newcastle - Oncology Waratah, New South Wales
Cancer Hospital, Chinese Academy of Medical Sciences Beijing, Beijing Municipality
CardioMed S.R.L. Cluj-Napoca,
Careggi University Hospital - Oncologia Clinica Florence,
Careggi University Hospital - Oncologia Clinica Florence,
Centre Antoine Lacassagne - Departement Oncologie Nice, Provence-Alpes-Côte d'Azur Region
Centre Hospitalier Intercommunal Creteil - Service de pneumologie Créteil, Île-de-France Region
Centre Hospitalier Michallon Grenoble - Service pneumologie La Tronche, Auvergne-Rhône-Alpes
Centre Hospitalier Universitaire de Limoges - unite oncologie thoracique Limoges, New Aquitaine
Centro Médico Privado CEMAIC Córdoba,
Centro Paulista de Oncologia (CPO) - Sao Paulo - Faria Lima Brasília, Federal District
Centro Ricerche Cliniche Di Verona S.r.l. - Oncologia Verona,
Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC) Buenos Aires,
Centro de Investigaciones Clínicas, Clínica Viedma Viedma, Río Negro Province
Centro de Pesquisa da Clínica de Oncologia Reichow Blumenau, Santa Catarina
Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati Aviano, Friuli Venezia Giulia
Centrul de Oncologie Sfantul Nectarie Craiova,
Charité Universitätsmedizin Berlin CBF - Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie Berlin,
Chi-Mei Medical Center, Liouyine Tainan,
Chonnam National University Hwasun Hospital | Pulmonology and Critical Care Medicine Hwasun-gun, Jeollanam-do
Chung Shan Medical University Hospital Taichung,
Chungbuk National University Hospital | Hematology and Oncology Chungcheongbuk-do, North Chungcheong
Clinica Integral Internacional de Oncologia S. de R.L. de C.V. Puebla City,
Columbia Asia Hospital Bukit Rimau Shah Alam, Selangor
Complex Oncology Center - Plovdiv EOOD Plovdiv,
Complexo Hospitalario Universitario A Coruna | Oncologia A Coruña,
Concord Repatriation General Hospital - Medical Oncology Clinical Trials Unit Concord, New South Wales
Curie Oncology | Farrer Singapore,
Docrates Mehiläinen Syöpäsairaala Helsinki, Uusimaa
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii Wroclaw,
Ege Universitesi Tip Fakultesi Hastanesi Izmir, Bornova
Fakultna Nemocnica Trnava Trnava, Trnava Region
Fakultní Nemocnice Olomouc - Klinika plicních nemocí a tuberkulózy Olomouc, Olomouc Region
Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1 Milan, Lombardy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOSD Oncologia Toraco-Polmonare Rome, Lazio
Fujian Cancer Hospital Fuzhou, Fujian
Fundacao Champalimaud | Centro Clinico Champalimaud - Unidade Investigacao Clinica Lisbon,
Fundacion Instituto Valenciano De Oncologia | Oncologia Valencia,
Fundación CENIT para la Investigación en Neurociencias Buenos Aires,
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, São Paulo
General Hospital of Athens "Alexandra''-Plasma Cell Dyscrasias,Department of Clinical Therapeutics,School of Medicine,NKUA Athens,
General University Hospital Of Larissa-Department of Medical Oncology Larissa,
Genesis Hospital- Department of Pathological Oncology Pylaia Thessaloniki, Thessaloniki
Geniko Nosokomeio Thessalonikis George Papanikolaou-Pulmonary Department Thessaloniki,
Gleneagles Penang Medical Center George Town, Pulau Pinang
Guangxi Medical University (GXMU) - Affiliated Tumor Hospital Nanning, Guangxi
Gustave Roussy - Departement Oncologie-Radiotherapie Villejuif, Île-de-France Region
Gyeongsang National University Hospital | Oncology Jinju, Gyeongsangnam-do
HFR Freiburg - Kantonsspital Fribourg,
Harbin Medical University Cancer Hospital Ha’erbin,
Hokkaido University Hospital Sapporo, Hokkaido
Hong Kong United Oncology Centre Kowloon,
Hopital Foch - Oncologie digestive et thoracique Suresnes, Île-de-France Region
Hopital La Cavale Blanche - CHU de Brest - institut de cancerologie et d'imagerie Brest, Brittany Region
Hopital Nord Laennec - Oncologie medicale thoracique et digestive Nantes, Pays de la Loire Region
Hospital Clinic De Barcelona | Oncologia Barcelona,
Hospital General Universitario Gregorio Marañón | Oncología Madrid,
Hospital Germans Trias I Pujol | Oncologia Badalona, Barcelona
Hospital Pedro Hispano | Clinical Research Center Matosinhos Municipality, Porto District
Hospital Sirio Libanes São Paulo,
Hospital Sirio-Libanes (HSL) - Centro de Oncologia - Brasilia São Paulo, São Paulo
Hospital Universitari Dexeus Grupo Quironsalud | Oncologia Barcelona,
Hospital Universitari Vall D Hebron | Oncologia Barcelona,
Hospital Universitario De Navarra | Oncologia Pamplona, Navarre
Hospital Universitario Fundacion Jimenez Diaz | Oncologia Madrid,
Hospital Universitario Puerta De Hierro De Majadahonda | Oncologia Majadahonda, Madrid
Hospital Universitario Ramon Y Cajal | Oncologia Madrid,
Hospital Universitario Y Politecnico La Fe | Oncologia Valencia,
Hospital Universitrio Dr. José Eleuterio González. Servicio de Oncologia Monterrey,
Hospital de Base | Funfarme - Centro Integrado de Pesquisa - Cardiologia São José do Rio Preto, São Paulo
Hubei Cancer Hospital Wuhan,
Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia Rozzano, Lombardy
Hunan Cancer Hospital - Oncology Department Changsha, Hunan
I.A.Ü. VM Medical Park Florya Hastanesi Küçükçekmece, Istanbul
I.F.O. Istituti Fisioterapici Ospitalieri_Ospedale Regina Elena -- Oncologia Medica 2 Rome, Lazio
IPO Porto Porto,
Institut Bergonié - Unicancer Nouvelle Aquitaine Bordeaux, New Aquitaine
Institut Coeur Poumon CHRU Lille - Pole Cardio-vasculaire et pulmonaire Lille, Hauts-de-France
Institut Curie - Paris - Oncologie medicale Paris, Île-de-France Region
Institut de Cancerologie Ouest - Saint-Herblain Saint-Herblain, Pays de la Loire Region
Instituto Argentino de Diagnostico y Tratamiento (IADT) TBC, Buenos Aires
Instituto Nacional De Cancerologia Bogotá,
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu (IOB); Oncologie Medicala II Bucharest,
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca,
Instytut Gruzlicy i Chorob Pluc Warsaw,
Irmandade Santa Casa de Misericordia de Porto Alegre | Oncology São Paulo, São Paulo
Istanbul Medeniyet Üniversitesi Göztepe Süleyman Yalçin Sehir Hastanesi Kadıköy, Istanbul
Istituto Europeo di Oncologia s.r.l - Oncologia Toracica Milan, Lombardy
Istituto Oncologico Veneto_Padova - UOC Oncologia 2 Padova, Veneto
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. - GDP Toracica Meldola, Emilia-Romagna
Jewish General Hospital | Pulmonary Oncology Montreal, Quebec
Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University Nanjing, Jiangsu
Jilin Cancer Hospital Changchun, Jilin
John B. Amos Cancer Center Columbus, Georgia
Kansai Medical University Hospital Hirakata,
Kantonsspital Baden Baden, Canton of Aargau
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Kindai University Hospital Sakai,
Kitasato University Hospital Sagamihara,
Klinik Floridsdorf, Pneumo-onkologische Ambulanz und Tagesklinik Vienna,
Kliniken der Stadt Köln gGmbH - Krankenhaus Merheim - Lungenklinik Cologne, North Rhine-Westphalia
Klinikum Nürnberg - Klinik für Innere Medizin 3, Schwerpunkt Pneumologie (Lungenheilkunde) Nuremberg, Bavaria
Kobe University Hospital Kobe,
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabánya, Komárom-Esztergom
Krajská nemocnice T. Bati - Pneumoonkologická a klinická onkologie Zlín, Zlín
Kyiv City Clinical Oncology Center - Department of Chemotherapy #1 Kyiv,
LLC "RDP Ukraine" - Medical Department Dnipro,
Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal, Rio Grande do Norte
Limited Liability Company "MedOffice Group Medical Center" Kyiv,
LinYi Cancer Hospital (Linyi Tumor Hospital) Linyi, Shandong
Lungenklinik Hemer, Thorakale Onkologie und onkologische Palliativmedizin Hemer, North Rhine-Westphalia
M Health Fairview Masonic Cancer Clinic - Clinics and Surgery Center Minneapolis, Minnesota
MHAT "Heart and brain" Pleven Pleven, Pleven Province
MHAT Park Hospital EOOD Plovdiv, Plovdiv Province
MHAT Serdika Sofia, Sofia City Province
MHAT Sveta Marina EAD Varna, Varna Province
MHAT Uni Hospital Panagyurishte, Pazardzhik Province
MNCE "Uzhhorod City Multidisciplinary Clinical Hospital" -Oncology Department Uzhhorod,
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Istanbul,
Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP) Brno, South Moravian
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy w Otwocku Otwock,
Medical Center LLC "Verum Expert Clinic" Kyiv,
Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie Vienna, State of Vienna
Memorial Cancer Institute at Miramar Miramar, Florida
Metropolitan Hospital- 4th Oncology Clinic Piraeus,
Moffitt Cancer Center Tampa, Florida
Moffitt Cancer Center - Magnolia Campus Tampa, Florida
Multiprofile Hospital for Active Treatment "Sveta Sofia" Sofia, Sofia City Province
Municipal Enterprise Rivne Regional Antitumor Center of the Rivne Regional Council, Abdominal department Rivne,
NAIC - Instituto do Cancer Bauru, São Paulo
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School Nanjing, Jiangsu
NSW Health - Blacktown Hospital Blacktown, New South Wales
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej Warsaw, Masovian Voivodeship
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Nowotworow Pluca i Klatki Piersiowej Warsaw, Masovian Voivodeship
National Cancer Center Hospital East Kashiwa,
National Cancer Center Singapore - Oncology Department Singapore,
National Cancer Center Singapore - Oncology Department Singapore,
National Cheng Kung University Hospital Tainan,
National Hospital Organization Himeji Medical Center Himeji,
National Hospital Organization Kyushu Medical Center Fukuoka,
National Hospital Organization Nagoya Medical Center Nagoya,
National Hospital Organization-Yamaguchi-Ube Medical Center (Sanyo Hospital) Ube, Yamaguchi
National Taiwan University Hospital Taipei,
National Taiwan University Hospital (NTUH) - Cancer Research Center Taipei,
Nederlands Kanker Instituut Amsterdam, North Holland
Nemocnice AGEL Nový Jicín a.s. - Oddelení radioterapie a onkologie Nový Jicín, Moravian-Silesian Region
Nemocnice AGEL Ostrava-Vítkovice a. s. - Plicní oddelení Ostrava - Vítkovice, Moravian-Silesian Region
Niigata Cancer Center Hospital Niigata,
Nippon Medical School - Nippon Medical School Hospital - Cancer Center Bunkyo-ku, Tokyo
Norrlands Universitetssjukhus Umeå - Cancercentrum Umeå, Västerbotten County
ONCARE Treatment Center San Pedro Garza García,
Odense University Hospital | Svendborg Sygehus - Oncology Department Odense, Region Syddanmark
Oncare Viaducto Nápoles Mexico City,
OncoCare Cancer Centre | Gleneagles Medical Centre Singapore,
Oncocenter Puebla City,
Oncologia Integral Satelite Naucalpan,
Osaka International Cancer Institute Osaka,
Ospedale San Raffaele s.r.l. - Oncologia Medica Milan,
Ospedale Vito Fazzi Lecce - Oncologia Lecce,
POKO Poprad s.r.o. Poprad, Presov
Patty & George Hoag Cancer Center Newport Beach, California
Piedmont Healthcare - Atlanta Atlanta, Georgia
Prince of Wales Hospital Shatin,
Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology Toronto, Ontario
Private Enterprise Private Production Company "Acinus", Treatment and Diagnostic Center Kropyvnytskyi,
Profound Research - OMG - Royal Oak Cancer Center Royal Oak, Michigan
Profound Research -OMG - TriAtria Cancer Center Farmington Hills, Michigan
Pronutrir Fortaleza - CE Fortaleza, Ceará
Providence Cancer Institute - Franz Clinic Portland, Oregon
Providence Oncology and Hematology Care Clinic Westside Portland, Oregon
Pusan National University Yangsan Hospital Yangsan,
Queen Elizabeth Hospital Hong Kong Hong Kong, Hong Kong SAR
Queen Mary Hospital Hong Kong,
R.J. Zuckerberg Cancer Center New Hyde Park, New York
Radboud University Medical Center | Afdeling Interne Geneeskunde Nijmegen, Gelderland
Radiotherapy Center Cluj SRL Flore?ti, Comuna Floresti
Raffles Cancer Centre Singapore,
Rede DoR Recife - PE Recife, Pernambuco
Regional Medical Oncology Centre_Oncology Chemotherapy Department Lutsk,
Regionshospitalet Gødstrup - Medicinsk afdeling Herning, Central Jutland
Rigshospitalet Copenhagen University Hospital | Oncology Department Copenhagen, Capital Region
Robert Bosch Krankenhaus - Haematologie, Onkologie und Palliativmedizin Stuttgart, Baden-Wurttemberg
Royal Surrey County Hospital Guildford, Surrey
S.C Ovidius Clinical Hospital SRL - Oncology Department Ovidiu,
Saitama Cancer Center Saitama,
Sakarya Universitesi Egitim ve Arastirma Hastanesi Sakarya,
Samsung Medical Center - Oncology Department Seoul,
Sc Oncolab Srl Craiova, Dolj
Sendai Kousei Hospital Miyagi,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System - Oncology Department Seoul,
Shaare Zedek Medical Center (SZMC) Jerusalem,
Shandong University - Shandong Cancer Hospital Jinan, Shandong
Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai, Shanghai Municipality
Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department Hangzhou, Zhejiang
Skånes Universitetssjukhus - Lund - Lungmedicin Lund, Skåne County
Soroka Medical Center- Legacy Heritage Cancer Center Beersheba,
Specialized Hospital for Active Treatment of Oncology Sofia, Sofia City Province
Spitalul Clinic Coltea Bucharest,
St.Vincent's Hospital - Oncology Department Suwon, Gyeonggi-do
Sunway Medical Centre Subang Jaya,
Sunway Medical Centre Penang Perai, Pulau Pinang
Swietokrzyskie Centrum Onkologii Kielce,
Taichung Veterans General Hospital Taichung,
Taipei Veterans General Hospital Taipei,
Tan Tock Seng Hospital Singapore,
Taylor Cancer Research Center Maumee, Ohio
Tel- Aviv Sourasky Medical Center - Nephrology Tel Aviv,
The Canberra Hospital (TCH) - Canberra Region Cancer Centre (CRCC) Garran,
The First Affiliated Hospital of Guangzhou Medical University Guangzhou,
The Oncology Institute of Hope and Innovation - Fort Lauderdale 17th Street Fort Lauderdale, Florida
The People's Liberation Army General Hospital (Beijing 301 Hospital) Beijing, Beijing Municipality
The University of Chicago Medical Center - Hyde Park - Hematology & Oncology Chicago, Illinois
The University of Texas MD Anderson Cancer Center - Texas Medical Center Houston, Texas
Thoracic General Hospital Of Athens I Sotiria-3rd University Department of Internal Medicine Athens,
Toowoomba Hospital Oncology Clinical Trials Toowoomba, Queensland
Torbay Hospital Torquay,
Tottori University Hospital Yonago,
Turku University Hospital, Turun yliopistollinen sairaala (TYKS) - Keuhkosairauksien poliklinikka Turku, Southwest Finland
UC Medical Center - Oncology Cincinnati, Ohio
UC San Diego Health - Moores Cancer Center San Diego, California
UCLA Health Santa Monica Cancer Care Santa Monica, California
UCSF Bakar Precision Cancer Medicine Building - Thoracic Surgery and Oncology San Francisco, California
UM Greenebaum Comprehensive Cancer Center Baltimore, Maryland
UMass Memorial Medical Center - University Campus - Hematology/Oncology Worcester, Massachusetts
UZ Leuven Gasthuisberg - Pneumology Department Leuven, Flemish Brabant
Unidade Local de Saúde de Coimbra, E.P.E. - Hospitais da Universidade de Coimbra - Serviço de Urologia Coimbra,
Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III Vienna, State of Salzburg
Uniklinikum Salzburg, Universitätsklinik für Pneumologie/ Lungenheilkunde Vienna, State of Salzburg
Union Hospi, Tongji Med College, Huazhong Univ. Scien&Tech Wuhan, Hubei
Universitaetsklinikum Essen - Innere Klinik (Tumorforschung) Essen, North Rhine-Westphalia
Universitaetsklinikum Giessen und Marburg - Medizinische Klinik IV Organonkologie Giessen, Hesse
Universiti Malaya Medical Centre Kuala Lumpur, Kuala Lumpur
University General Hospital Attikon, 2nd Department of Propaedeutic and Internal Medicine Athens,
University General Hospital Attikon-4th Department of Internal Medicine Chaïdári, Attica
University Hospital Kebangsaan Malaysia Cheras, Kuala Lumpur and Selangor
University Hospital Simmons Cancer Center Lung/Head Neck Clinic Dallas, Texas
University Multiprofile Hospital For Active Treatment Sofiamed OOD, Sofia Sofia, Sofia City Province
University of Electronic Science & Technology of China - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital) Chengdu, Sichuan
University of Illinois Hospital - Outpatient Cancer Care Center Chicago, Illinois
University of the Sunshine Coast Buderim, Queensland
Universitätsklinikum Frankfurt - Medizinische Klinik II, Hämatologie und Onkologie Frankfurt am Main, Hesse
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego w Lodzi Lodz, Łódź Voivodeship
Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Podlaskie Voivodeship
VCU Health Ambulatory Care Center - Cardiology Virginia, Washington
Velindre University NHS Trust | Velindre Cancer Centre - Clinical Trials Unit Cardiff, Wales
West China Hospital Sichuan University Chengdu, Sichuan
Wielkopolskie Centrum Pulmonologii i Torakochirurgii Poznan,
Xiamen University - The First Affiliated Hospital Xiamen, Fujian
Zhejiang Cancer Hospital Hangzhou,
Zhejiang University School of Medicine - Taizhou Hospital of Zhejiang Province Taizhou, Jiangsu
Zhongshan Hospital, Fudan University Shanghai, Shanghai Municipality
hopital Emile Muller - Service Pneumologie Mulhouse, Grand Est
hopital Lyon sud HCL - Pneumologie aigue specialisee et cancerologie thoracique Pierre-Bénite, Auvergne-Rhône-Alpes
hopital cochin APHP - service de pneumologie Paris, Île-de-France Region
hospital Italiano de Buenos Aires CABA, Buenos Aires

A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)

Toll Free Number - Trialsites@msd.com

NCT06136559
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following: * Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy. * Has at least 1 marker of disease burden. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization. * Has the ability to swallow and retain oral medication. * 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 deoxyribonucleic acid (DNA) viral load before randomization. * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening. * Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following: * Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection. * Has gastrointestinal (GI) dysfunction that may affect drug absorption. * Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL. * Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening. * Has clinically significant cardiovascular disease. * Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients. * Has history of severe bleeding disorder. * Has known additional malignancy that is progressing or has required active treatment within the past 2 years. * Has received any systemic anticancer therapy for CLL/SLL. * Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors. * 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. Administration of killed vaccines are allowed. * Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration. * Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening. * Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
DRUG: Nemtabrutinib, DRUG: Ibrutinib, DRUG: Acalabrutinib
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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Study Locations

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Location Contacts
AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205) Mechelen, Antwerpen
Aalborg Universitetshospital, Syd ( Site 0403) Aalborg, North Denmark
Akershus Universitetssykehus ( Site 0902) Lørenskog, Akershus
Alta Bates Summit Medical Center ( Site 0004) Berkeley, California
Anhui Provincial Cancer Hospital ( Site 2001) Hefei, Anhui
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1407) Ankara,
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 1401) Ankara,
Antalya Egitim ve Arastırma Hastanesi ( Site 1409) Antalya,
Aotearoa Clinical Trials ( Site 3201) Auckland,
Arizona Oncology Associates - NAHOA ( Site 8007) Prescott, Arizona
BC Cancer Kelowna ( Site 0112) Kelowna, British Columbia
BC Cancer Victoria ( Site 0109) Victoria, British Columbia
Banner MD Anderson Cancer Center ( Site 0059) Gilbert, Arizona
Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0051) Phoenix, Arizona
Barnet Hospital ( Site 3005) Barnet,
Bnai Zion Medical Center ( Site 1505) Haifa,
Bradfordhill-Clinical Area ( Site 2310) Santiago, Region M. de Santiago
Cancer Care Associates Of York ( Site 0005) York, Pennsylvania
Cancer Institute Hospital of JFCR ( Site 1906) Koto, Tokyo
Care Access - South Pasadena ( Site 0070) Pasadena, California
Carolina Oncology Specialists, PA ( Site 0054) Charlotte, North Carolina
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0100) Rimouski, Quebec
Centro Medico Monte Carmelo-Oncology ( Site 2706) Arequipa, Ariqipa
Centro de Infusion Superare ( Site 2602) Mexico City, Mexico City
Champalimaud Foundation ( Site 3102) Lisbon, Lisbon District
Chang Gung Medical Foundation-Linkou Branch ( Site 1703) Taoyuan,
Chang Gung Memorial Hospital at Kaohsiung-Division of Hematology and Oncology ( Site 1702) Kaohsiung City,
Chiba Cancer Center ( Site 1905) Chiba,
Chongqing University Cancer Hospital ( Site 2041) Chongqing, Chongqing Municipality
Chulalongkorn University ( Site 1802) Pathumwan, Bangkok
City Hospital, Nottingham University Hospitals NHS Trust ( Site 3003) Nottingham,
Clermont Oncology Center ( Site 0046) Clermont, Florida
Clínica Alemana de Santiago-Unidad de Investigaciones ( Site 2306) Santiago, Region M. de Santiago
Clínica Anglo Americana ( Site 2701) Lima,
Constantiaberg Haematology ( Site 1106) Plumstead, Western Cape
Consultants in Medical Oncology and Hematology (CMOH) ( Site 8002) Broomall, Pennsylvania
Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011) Grand Rapids, Michigan
Eastern CT Hematology & Oncology Associates ( Site 0033) Norwich, Connecticut
Ege Universitesi Hastanesi ( Site 1404) Izmir,
Evangelismos General Hospital of Athens ( Site 0700) Athens, Attica
FALP-UIDO ( Site 2300) Santiago, Region M. de Santiago
Faculty of Medicine Siriraj Hospital-Division of Hematology, Department of Medicine ( Site 1801) Bangkok, Bangkok
Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0301) Hradec Králové,
Fakultni nemocnice Olomouc ( Site 0303) Olomouc,
Florida Cancer Specialists - East ( Site 7002) West Palm Beach, Florida
Florida Cancer Specialists - South ( Site 7001) Fort Myers, Florida
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 2402) Cali, Valle del Cauca Department
Galilee Medical Center ( Site 1507) Nahariya,
General Hospital of Athens "Laiko" ( Site 0704) Athens, Attica
GenesisCare - Bristol ( Site 3011) Bristol, South Gloucestershire
GenesisCare - Cambridge ( Site 3001) Newmarket, Suffolk
GenesisCare - Windsor ( Site 3002) Windsor, Windsor And Maidenhead
Groote Schuur Hospital-Clinical Haematology ( Site 1100) Cape Town, Western Cape
Grupo Médico ASSET ( Site 2611) Mexico City,
Guangxi Medical University Affiliated Tumor Hospital ( Site 2004) Nanning, Guangxi
Gunma University Hospital ( Site 1903) Maebashi, Gunma
HOSPITAL CLÍNIC DE BARCELONA ( Site 1202) Barcelona, Catalonia
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 1208) Majadahonda, Madrid, Comunidad de
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1209) Pozuelo de Alarcón, Madrid
Hadassah Medical Center-Hemato-Oncology ( Site 1500) Jerusalem,
Haemalife ( Site 1105) Kuilsriver, Western Cape
Hainan General Hospital ( Site 2018) Haikou, Hainan
Health Pharma Professional Research S.A. de C.V: ( Site 2608) Mexico City, Mexico City
Henan Cancer Hospital-hematology department ( Site 2025) Zhengzhou, Henan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital ( Site 1913) Hiroshima,
Hokkaido University Hospital ( Site 1900) Sapporo, Hokkaido
Hospital 9 De Julho ( Site 2206) São Paulo, São Paulo
Hospital Paulistano-Americas Oncologia ( Site 2202) São Paulo,
Hospital Pulau Pinang ( Site 1602) George Town, Pulau Pinang
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1206) Barcelona,
Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1201) Salamanca,
Hunan Cancer Hospital ( Site 2020) Changsha, Hunan
IMAT S.A.S ( Site 2401) Montería, Departamento de Córdoba
InVO Institut für Versorgungsforschung in der Onkologie ( Site 0606) Koblenz, Rhineland-Palatinate
Inova Schar Cancer Institute ( Site 0015) Fairfax, Virginia
Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 1207) L'Hospitalet Del Llobregat, Barcelona
Institute of hematology&blood disease hospital-Lymphoma ( Site 2005) Tianjin, Tianjin Municipality
Instituto Nacional de Câncer - INCA ( Site 2201) Rio de Janeiro,
Instituto Português de Oncologia de Lisboa Francisco Gentil ( Site 3103) Lisbon, Lisbon District
Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 3100) Porto,
Intermountain Health St. Mary's Regional Hospital ( Site 0025) Grand Junction, Colorado
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0052) Billings, Montana
Japanese Red Cross Osaka Hospital ( Site 1908) Osaka,
Jiangsu Province Hospital ( Site 2000) Nanjing, Jiangsu
Jiangxi Provincial Cancer Hospital ( Site 2009) Nanchang, Jiangxi
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) Hackensack, New Jersey
Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County
Kindai University Hospital ( Site 1909) Sakai, Osaka
Kliniken Maria Hilf ( Site 0603) Mönchengladbach, North Rhine-Westphalia
Kobe City Medical Center General Hospital ( Site 1910) Kobe, Hyōgo
Kyushu University Hospital ( Site 1914) Fukuoka,
Liuzhou People's Hospital ( Site 2029) Liuzhou, Guangxi
Lutheran Medical Center ( Site 0027) Golden, Colorado
Lynn Cancer Center at Boca Raton Regional Hospital ( Site 0063) Boca Raton, Florida
Maharaj Nakorn Chiang Mai Hospital ( Site 1800) Muang, Chiang Mai
Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1408) Istanbul,
McGill University Health Centre ( Site 0106) Montreal, Quebec
Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010) Spokane, Washington
Mega Medipol ( Site 1412) Istanbul,
MidAmerica Cancer Care, LLC ( Site 0043) Kansas City, Missouri
Moores Cancer Center ( Site 0003) La Jolla, California
Nagoya University Hospital ( Site 1907) Nagoya, Aichi-ken
Naresuan University Hospital ( Site 1804) Muang, Changwat Phitsanulok
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1000) Gliwice, Silesian Voivodeship
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 1004) Warsaw, Masovian Voivodeship
National Cheng Kung University Hospital ( Site 1700) Tainan,
National Taiwan University Hospital ( Site 1701) Taipei,
Netcare Pretoria East Hospital-Alberts Cellular Therapy ( Site 1101) Pretoria, Gauteng
New York Oncology Hematology, P.C. ( Site 0069) Albany, New York
North Shore Hospital-Department of Haematology ( Site 3200) Auckland,
Odense Universitetshospital-Department of Hematology ( Site 0401) Odense C, Region Syddanmark
Okayama University Hospital ( Site 1912) Okayama,
Ondokuz Mays Üniversitesi ( Site 1410) Samsun,
Onkologische Schwerpunktpraxis Kurfuerstendamm ( Site 0600) Berlin,
Oslo Universitetssykehus Rikshospitalet-Avdeling for blodsykdommer ( Site 0901) Oslo,
Owensboro Medical Health System ( Site 0066) Owensboro, Kentucky
Parkview Research Center at Parkview Regional Medical Center ( Site 0002) Fort Wayne, Indiana
Peking University First Hospital ( Site 2022) Beijing, Beijing Municipality
Peking University Third Hospital-Hematology ( Site 2011) Beijing, Beijing Municipality
Pratia MCM Krakow ( Site 1007) Krakow, Lesser Poland Voivodeship
Pratia Onkologia Katowice ( Site 1009) Katowice, Silesian Voivodeship
Queen Elizabeth Hospital ( Site 1603) Kota Kinabalu, Sabah
Queen Mary Hospital ( Site 3300) Hong Kong,
RPCI Oncology, PC- Northtowns ( Site 0061) Williamsville, New York
Rabin Medical Center ( Site 1504) Petah Tikva,
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 1503) Haifa,
Regions Hospital ( Site 0042) Saint Louis Park, Minnesota
Roskilde Sygehus-Department of Hematology ( Site 0402) Roskilde, Region Sjælland
Roswell Park Cancer Institute ( Site 0023) Buffalo, New York
Royal Lancaster Infirmary ( Site 3012) Lancaster, Lancashire
Royal North Shore Hospital ( Site 2806) St Leonards, New South Wales
SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048) Madison, Wisconsin
Saint Alphonsus Regional Medical Center ( Site 0067) Boise, Idaho
Saint Elizabeth Healthcare ( Site 0041) Edgewood, Kentucky
Saint Joseph Hospital ( Site 0026) Denver, Colorado
Samodzielny Publiczny Zakład Opieki Zdrowotnej MSWiA w Olsztynie-Oddzial Kliniczny Hematologii ( Site 1005) Olsztyn, Warmian-Masurian Voivodeship
Shaanxi provincial people's hospital ( Site 2012) Xi'an, Shaanxi
Shandong Cancer Hospital ( Site 2003) Jinan, Shandong
Shanxi Cancer Hospital ( Site 2033) Taiyuan, Shanxi
Sheba Medical Center-Hemato Oncology ( Site 1501) Ramat Gan,
Shimane University Hospital ( Site 1911) Izumo, Shimane
Sisli Florence Nightingale Hastanesi ( Site 1411) Istanbul,
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 2405) Valledupar, Cesar Department
Songklanagarind hospital ( Site 1803) Hat Yai, Changwat Songkhla
Southeastern Medical Oncology Center ( Site 0049) Goldsboro, North Carolina
Southern Medical University Nanfang Hospital-Department of Hematopathology ( Site 2006) Guangzhou, Guangdong
Southmead Hospital ( Site 3010) Bristol, Bristol, City of
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3006) London, London, City of
St James's University Hospital ( Site 3004) Leeds,
Summit Medical Group Cancer Center ( Site 0007) Florham Park, New Jersey
Sun Yat-sen University Cancer Center ( Site 2028) Guangzhou, Guangdong
Sykehuset i Vestfold ( Site 0903) Tønsberg, Vestfold
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0031) Nashville, Tennessee
Tennessee Oncology-Chattanooga ( Site 0045) Chattanooga, Tennessee
Texas Oncology - Central/South Texas ( Site 8008) Austin, Texas
Texas Oncology - Northeast Texas ( Site 8012) Tyler, Texas
Texas Oncology - San Antonio ( Site 8006) San Antonio, Texas
The Affiliated Hospital of Guizhou Medical University ( Site 2024) Guiyang, Guizhou
The Affiliated Hospital of Xuzhou Medical College ( Site 2013) Xuzhou, Jiangsu
The Center for Cancer and Blood Disorders ( Site 0032) Fort Worth, Texas
The Churchill Hospital ( Site 3007) Oxford, Oxfordshire
The First Affiliated Hospital of Nanchang University ( Site 2023) Nanchang, Jiangxi
The First Affliated Hospital of Suzhou University ( Site 2027) Suzhou, Jiangsu
The First Hospital of Jilin University-Hematology ( Site 2030) Changchun, Jilin
The Ottawa Hospital - General Campus ( Site 0102) Ottawa, Ontario
The Second Xiangya Hospital of Central South University ( Site 2010) Changsha, Hunan
The first Affiliated Hospital, Zhejiang University School of Medicine-Hematology ( Site 2002) Hangzhou, Zhejiang
Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 2019) Tianjin, Tianjin Municipality
Tohoku University Hospital ( Site 1901) Sendai, Miyagi
Tongji Hospital Affiliated to Tongji Medical College of HUST ( Site 2016) Wuhan, Hubei
Trakya University Medical Faculty Hospital-Hematology ( Site 1403) Edirne,
USA Mitchell Cancer Institute ( Site 0014) Mobile, Alabama
UZ Leuven-Hematology ( Site 0200) Leuven, Vlaams-Brabant
Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 3107) Vila Nova de Gaia, Porto District
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 3104) Lisbon,
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 3106) Lisbon,
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 2015) Wuhan, Hubei
Universitaetsklinikum Ulm. ( Site 0601) Ulm, Baden-Wurttemberg
University Hospital and UW Health Clinics ( Site 0006) Madison, Wisconsin
University Hospital of Alexandroupolis ( Site 0701) Alexandroupoli, East Macedonia and Thrace
University Hospital of Ioannina ( Site 0702) Ioannina,
University Malaya Medical Centre ( Site 1604) Lembah Pantai, Kuala Lumpur
University of Iowa Health Care. ( Site 0017) Iowa City, Iowa
University of Iowa Health Care. ( Site 0057) Waukee, Iowa
University of Virginia Cancer Center ( Site 0040) Charlottesville, Virginia
Universitätsklinikum Halle ( Site 0604) Halle, Saxony-Anhalt
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie-Oddział Hematoonkologii-Transplantacji Szpiku i Chem ( Site 1006) Lublin, Lublin Voivodeship
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1011) Gdansk, Pomeranian Voivodeship
VK&K Studien GbR ( Site 0607) Landshut, Bavaria
Virginia Commonwealth University (VCU) Medical Center ( Site 0030) Richmond, Virginia
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302) Prague,
Waikato Hospital-Haematology ( Site 3202) Hamilton, Waikato Region
West China Hospital, Sichuan University-Head and Neck Oncology ( Site 2026) Chengdu, Sichuan
William Osler Health System ( Site 0103) Brampton, Ontario
Wits Clinical Research ( Site 1102) Johannesburg, Gauteng
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oddział Hematologii i Transplantacji ( Site 1013) Słupsk, Pomeranian Voivodeship
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2014) Ürümqi, Xinjiang
Yamagata University Hospital ( Site 1902) Yamagata,
Yitzhak Shamir Medical Center. ( Site 1506) Ẕerifin,
Zhejiang Cancer Hospital ( Site 2017) Hangzhou, Zhejiang
hospital universitario de canarias ( Site 1205) San Cristóbal de La Laguna, Santa Cruz De Tenerife

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (SUPRAME)

Immatics US, Inc. - ctgovinquiries@immatics.com

NCT06743126
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Inclusion Criteria:
* Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic cutaneous melanoma * Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient * Life expectancy more than 6 months * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm) * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization and prior to trial treatment start.
Exclusion Criteria:
* Primary mucosal or uveal melanoma * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years * Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents. * History of cardiac conditions as per protocol * Prior allogenic stem cell transplantation or solid organ transplantation * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician * History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs * Known hypersensitivity to any of the rescue medications * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. * Any condition contraindicating leukapheresis * Pregnant or breastfeeding * Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment) * Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis, * Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis. * Patients with any active infection or ongoing reactivation of infection * Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months * Prior treatment with IMA203 * Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months * Patients with LDH greater than 2.0-fold ULN * Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment * Patients with active brain metastases or leptomeningeal metastases * Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization * Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment * Other protocol defined inclusion/exclusion criteria could apply
BIOLOGICAL: IMA203, BIOLOGICAL: nivolumab plus relatlimab, BIOLOGICAL: lifileucel, BIOLOGICAL: nivolumab, BIOLOGICAL: pembrolizumab, BIOLOGICAL: ipilimumab, DRUG: Dacarbazine, DRUG: temozolomide, DRUG: paclitaxel, DRUG: paclitaxel plus carboplatin, DRUG: Albumin-Bound Paclitaxel
Melanoma, Cutaneous Malignant
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AdventHealth, Orlando Orlando, Florida
Assistance Publique Hopitaux De Paris, Hôpital Saint Louis Paris,
Atlantic Health System/Morristown Medical Center Morristown, New Jersey Eric Whitman, MD - (eric.whitman@atlantichealth.org)
Avera Cancer Institute Sioux Falls, South Dakota Benjamin Solomon, MD - (Benjamin.Solomon@avera.org)
BC Cancer - Vancouver Vancouver, British Columbia Alison Weppler, MD - (alison.weppler@phsa.ca)
Baylor University Dallas, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts David McDermott, MD - (dmcdermo@bidmc.harvard.edu)
Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital Cambridge,
Centre Hospitalier Universitaire de Lille Lille,
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec
Charite Universitaetsmedizin Berlin KöR Berlin,
City of Hope National Medical Center Duarte, California Yan Xing, MD - (yxing@coh.org)
Cleveland Clinic, Taussig Cancer Institute Cleveland, Ohio James Isaac - (isaacsj3@ccf.org)
Cross Cancer Institute, Alberta Edmonton, Alberta
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Rotterdam,
Fox Chase Cancer Center Philadelphia, Pennsylvania Anthony J Olszanski, MD, RPh - (Anthony.Olszanski@FCCC.edu)
Fred Hutchinson Cancer Center Seattle, Washington Sylvia Lee, MD - (leesm@uw.edu)
Goethe University Frankfurt Frankfurt am Main,
Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center Glasgow,
Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital London,
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Amsterdam,
Honor Health Research Institute Scottsdale, Arizona Justin Moser, MD - (jmoser@honorhealth.com)
Huntsman Cancer Institute, University of Utah Salt Lake City, Utah Siwen Hu-Lieskovan, MD, PhD - (Siwen.Hu-Leiskovan@hci.utah.edu)
Institut Gustave Roussy Villejuif,
Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health New York, New York Maya Dimitrova, MD - (maya.dimitrova@nyulangone.org)
Lehigh Valley Topper Cancer Institute Allentown, Pennsylvania Rino Seedor, MD - (Rino.Seedor@jefferson.edu)
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic Rochester, Minnesota Seetharam Mahesh, MD - (Seetharam.Mahesh@mayo.edu)
Mayo Clinic Rochester, Minnesota Arkadiusz Dudek, MD, PhD - (dudek.arkadiusz@mayo.edu)
Mayo Clinic Florida Jacksonville, Florida Ruqin Chen, MD - (chen.ruqin@mayo.edu)
Memorial Sloan Kettering Cancer Center New York, New York James Smithy, MD - (smithyj@mskcc.org)
Moffitt Cancer Center Tampa, Florida
Ohio State University Columbus, Ohio
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital Oxford,
Providence Cancer Institute Franz Clinic Portland, Oregon Matthew Taylor, MD - (Matthew.Taylor@providence.org)
SCRI Oncology Partners Nashville, Tennessee
Stanford Cancer Center Palo Alto, California Alison Betof Warner, MD, PhD - (allison.betof@stanford.edu)
Technische Universitaet Dresden Dresden,
The Christie NHS Foundation Trust Manchester, Lancashire
The Royal Marsden NHS Foundation Trust London,
The University of Texas MD Anderson Cancer Center Houston, Texas Rodabe N Amaria, MD - (RNAmaria@mdanderson.org)
Thomas Jeffersion University, Sidney Kimmel Cancer Center Philadelphia, Pennsylvania Rino Seedor, MD - (Rino.Seedor@jefferson.edu)
UC San Diego Moores Cancer Center La Jolla, California Gregory Daniels, MD - (gdaniels@health.ucsd.edu)
UCLA Hematology/Oncology Los Angeles, California Bartosz Chmielowski, MD, PhD - (bchmielowski@mednet.ucla.edu)
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California Adil Daud, MD - (adil.daud@ucsf.edu)
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill, North Carolina Stergios Moschos, MD - (stergios_moschos@med.unc.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania Diwakar Davar, M.D. - (davard@upmc.edu)
Universitaet Leipzig Leipzig,
Universitaetsklinikum Bonn AöR Bonn,
Universitaetsklinikum Erlangen AöR Erlangen,
Universitaetsklinikum Essen AöR Essen,
Universitaetsklinikum Heidelberg AöR Heidelberg,
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Mainz,
Universitair Medisch Centrum Groningen Groningen,
Universitatsklinikum Koeln Cologne, Northrhine-W Estphalia
University Health Network, Princess Margaret Cancer Centre Toronto, Ontario Marcus Butler, MD - (Marcus.Butler@uhn.ca)
University Medical Center Hamburg-Eppendorf Hamburg,
University of Chicago Medical Center Chicago, Illinois Daniel Olson, MD - (dolson2@medicine.bsd.uchicago.edu)
University of Colorado, Anschutz Medical Campus Aurora, Colorado
University of MD Greenebaum Comprehensive Cancer Center Baltimore, Maryland Petra Hausner, MD, PhD - (phausner@umm.edu)
University of Miami - Sylvester Comprehensive Cancer Cente Miami, Florida Leonel Hernandez-Aya, MD - (l.hernandezaya@med.miami.edu)
University of Michigan Ann Arbor, Michigan Leslie Fecher, MD - (lfecher@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Bhavina Sharma, MD - (bhsharma@unmc.edu)
University of Pennsylvania, Abramson Cancer Center Philadelphia, Pennsylvania
University of Rochester Rochester, New York Sahasrabudhe Deepak, MD - (deepak_sahasrabudhe@urmc.rochester.edu)
University of Southampton NHS Foundation Trust, Southampton General Hospital Southampton,
University of Texas Southwestern Medical Center Dallas, Texas Sanjay Chandrasekaran, MD - (Sanjay.Chandrasekaran@utsouthwestern.edu)
University of Wisconsin Madison, Wisconsin
Virginia Commonwealth University Richmond, Virginia Andrew Poklepovic, MD - (andrew.poklepovic@vcuhealth.org)
Winship Cancer Institute, Emory University Atlanta, Georgia
Yale Cancer Center New Haven, Connecticut

Advancing Water Security: A Community Participatory School-Based Hydration Intervention

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

Melanie Bean
NCT06714929
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Inclusion Criteria:
* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible * BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g) * Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district. * Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Exclusion Criteria:
* Lunchroom observations: None. * BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration * Student surveys: None. * Staff surveys: None.
BEHAVIORAL: Hydration
Dental Caries, Obesity Prevention
hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
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Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, PhD - (melanie.bean@vcuhealth.org)

Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy (REBIRTH)

Dennis McNamara, MD - mcnamaradm@upmc.edu

NCT05180773
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Inclusion Criteria:

• Presentation with a new diagnosis of peripartum cardiomyopathy
• Post-delivery and within the first 5 months post-partum.
• Clinical assessment of an LVEF \< or =0.40 within 4 weeks of consent for randomized control trial
• Clinical assessment of an LVEF \< or =0.40 within 8 weeks of consent for breastfeeding cohort
• Age \> or = 18.
Exclusion Criteria:

• Previous diagnosis of cardiomyopathy, valvular disease or congenital heart disease (with the exception of women with a history of peripartum cardiomyopathy with complete recovery and a documented LVEF \> 0.55 prior to or in early pregnancy)
• Refractory hypertension (Systolic \>160 or Diastolic \> 95) either at the time of enrollment or at the time of the qualifying LVEF.
• Postpartum women currently breastfeeding and planning to continue.
• Evidence of coronary artery disease (\>50% stenosis of major epicardial vessel or positive non-invasive stress test)
• Previous cardiac transplant
• Current durable LVAD support
• Currently requiring support with extracorporeal membrane oxygenation (ECMO)
• Current history of alcohol or drug abuse
• Chemotherapy or chest radiation within 5 years of enrollment
• Evidence of ongoing bacterial septicemia
• Medical, social or psychiatric condition which limit the ability to comply with follow-up.
DRUG: Bromocriptine, DRUG: Placebo, DRUG: Guideline Directed Medical Therapy for Heart Failure (GDMT), DRUG: Rivaroxaban, DRUG: Second Placebo
Peripartum Cardiomyopathy, Postpartum
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Albert Einstein College of Medicine/ Montefiore Medical Center The Bronx, New York Vanya Prasad - (vprasad@montefiore.org)
Ascension St. Vincent Heart Center Indianapolis, Indiana Anne Renick - (anne.renick@ascension.org) Regina Margiotti - (RAMARGIO@ascension.org)
Atrium Health Sanger Heart and Vascular Institute Charlotte, North Carolina Sangeetha Dinakaran - (Sangeetha.dinakaran@atriumhealth.org)
Baylor College of Medicine Houston, Texas Sandra Pena - (sandra.pena@bcm.edu)
Brigham and Women's Hospital Boston, Massachusetts Audrey Yun - (ayun1@bwh.harvard.edu) Mariam Markabani - (mmarkabani@bwh.harvard.edu)
Cedars-Sinai Medical Center Los Angeles, California Odette Chida Ibarra - (odette.chidaibarra@cshs.org)
Cleveland Clinic Cleveland, Ohio Barbara Gus - (gusb@ccf.org)
Columbia University Irving Medical Center New York, New York Hadley Reinke - (hnr2111@cumc.columbia.edu) Jessica Idumonyi - (joi2102@cumc.columbia.edu)
Emory University Atlanta, Georgia Eisha Udeshi - (eudeshi@emory.edu) Nino Kavtaradze - (nkavtar@emory.edu)
Hartford Hospital Hartford, Connecticut Khadija El Aoudi - (Khadija.ElAoudi@hhchealth.org)
Henry Ford Health System Novi, Michigan Jodi Carter - (jcarte23@hfhs.org)
Indiana University/Indiana University Health Indianapolis, Indiana Srdjan Kurbalija - (skurbalija@iuhealth.org)
Inova Healthcare Services Fairfax, Virginia Joanne Wotring - (joanne.wotring@inova.org)
Intermountain Medical Center Murray, Utah Morgan McClure - (morgan.mcclure@imail.org)
Johns Hopkins University Baltimore, Maryland Yavette Goldsborough - (ygoldsb1@jhmi.edu)
Karen L Florio, MD Columbia, Missouri Kaycee Mackanos - (kmznn@umsystem.edu)
Keck School of Medicine of USC Los Angeles, California Jorge Caro - (jorge.caro@med.usc.edu)
Lehigh Valley Health Network Allentown, Pennsylvania
Louisiana State University Shreveport, Louisiana Monicah Jepkemboi - (monicah.jepkemboi@lsuhs.edu)
Massachusetts General Hospital Boston, Massachusetts Monica Duan - (mduan2@mgb.org)
Mayo Clinic, Florida Jacksonville, Florida Jena Hayes - (hayes.jena@mayo.edu) Ann Dunshee - (Dunshee.Ann@mayo.edu)
Mayo Clinic, Rochester Rochester, Minnesota Lezlie Peterson - (Johnson.Lezlie@mayo.edu) Kayla Syring - (Syring.Kayla@mayo.edu)
Medical College of Wisconsin Milwaukee, Wisconsin Faith Boemer - (fboerner@mcw.edu)
Medical University of South Carolina Charleston, South Carolina Virginia Theodorof - (theodoro@musc.edu) Olivia Washington - (washoliv@musc.edu)
Minneapolis Heart Institute Foundation Minneapolis, Minnesota Sarah Schwager - (Sarah.Schwager@allina.com) Molly Fuller - (Molly.Fuller@allina.com)
Mount Sinai Hospital New York, New York Lovelyne Julien - (lovelyn.julien@mountsinai.org) Tiffany Soto - (tiffany.soto@mssm.edu)
NYU Langone Health New York, New York Lucia Muzzarelli - (Lucia.Muzzarelli@nyulangone.org)
Northwestern University Chicago, Illinois Kathleen Flores - (Kathleen.Flores@northwestern.edu)
Oklahoma University Health Science Center Oklahoma City, Oklahoma Natalie Feland - (natalie-feland@ouhsc.edu)
Old Dominion University Norfolk, Virginia Kristin Ayers - (ayerskl@evms.edu)
Penn State Hershey Medical Center Hershey, Pennsylvania Katie Loffredo - (kloffredo@pennstatehealth.psu.edu) Veronica Bausher - (vbausher@pennstatehealth.psu.edu)
Rhode Island Hospital Providence, Rhode Island Kelly Franchetti, RN - (kfranchetti@lifespan.org)
Saint Luke's Hospital of Kansas City Kansas City, Missouri Rosann Gans, RN - (rgans@saint-lukes.org)
Stanford University Stanford, California Tamara Bazouzi - (bazouzit@stanford.edu)
Stern Cardiovascular Foundation, Inc Germantown, Tennessee Denise Peeler - (denise.peeler@sterncardio.com) Kari Fondren - (kari.fondren@sterncardio.com)
Stony Brook Medicine Stony Brook, New York Uzma Usmani - (Uzma.Usmani@stonybrookmedicine.edu)
Temple Heart and Vascular Institute Philadelphia, Pennsylvania Jennie Wong - (jennie.wong@tuhs.temple.edu)
UT Southern Medical Center Dallas, Texas
University Hospitals, Cleveland Medical Center Cleveland, Ohio Emily Mullenax - (Emily.Mullenax@UHhospitals.org)
University of Alabama Birmingham Birmingham, Alabama LaTangellia Walker - (latangelliadwalker@uabmc.edu) Nancy Saxon - (nbsaxon@uabmc.edu)
University of Arizona Sarver Heart Center Tucson, Arizona Lizzette Cruz - (marquez@shc.arizona.edu)
University of California Irvine Health Orange, California Linh Huỳnh, MPH - (plhuynh@hs.uci.edu)
University of California San Diego San Diego, California Rachel Han - (rah015@health.ucsd.edu)
University of Colorado Anschutz Medical Campus Aurora, Colorado Jamie Demmitt, BA - (jamie.demmitt@cuanschutz.edu)
University of Florida Gainesville, Florida David Solares - (David.Solares@medicine.ufl.edu) Vanessa Holway Scheuble - (Vanessa.Scheuble@medicine.ufl.edu)
University of Illinois Health Heart Center Chicago, Illinois Muriel Chen - (yining@uic.edu)
University of Iowa Hospitals and Clinic Iowa City, Iowa Traci Parks - (traci-parks@uiowa.edu) Page Scovel - (page-scovel@uiowa.edu)
University of Kentucky, Gill Heart & Vascular Institute Lexington, Kentucky Jennifer Isaacs - (Jennifer.isaacs@uky.edu) Travis Sexton - (trsext2@uky.edu)
University of Maryland Medical Center, Baltimore Baltimore, Maryland Caitlin Hearn - (chearn@som.umaryland.edu)
University of Michigan Ann Arbor, Michigan Sharada Lanka - (slanka@med.umich.edu)
University of Minnesota Minneapolis, Minnesota Melanie Farinella - (crawl027@umn.edu)
University of Pennsylvania Philadelphia, Pennsylvania Alavi Hossain - (Alavi.Hossain@Pennmedicine.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Dennis McNamara, MD - (mcnamaradm@upmc.edu) Donna Simpson, CRNP, MPH - (simpsondm@upmc.edu)
University of Rochester Rochester, New York Lori Caufield, RN BSN CCRC - (lori_caufield@urmc.rochester.edu)
University of South Florida Tampa, Florida Amanda McNamara - (alett1@usf.edu) Laura Cordero - (lauracordero@usf.edu)
University of Texas Health San Antonio San Antonio, Texas
University of Vermont Medical Center Burlington, Vermont Meghan Sesera, RN - (meghan.sesera@uvmhealth.org) Michaelanne Rowen - (Michaelanne.Rowen@uvmhealth.org)
University of Virginia Charlottesville, Virginia Frankie Shelton - (ZSB5KR@uvahealth.org) Caroline Flournoy - (clf4w@uvahealth.org)
University of Washington Medical Center Seattle, Washington Adele Stefanowicz - (amstef99@cardiology.washington.edu)
University of Wisconsin Madison Madison, Wisconsin Karen Olson - (kjolson@medicine.wisc.edu)
Vanderbilt Nashville, Tennessee Olivia Patridge - (olivia.h.patridge@vumc.org)
Virginia Commonwealth University Richmond, Virginia Melissa Sears - (melissa.sears@vcuhealth.org)
Washington University School of Medicine St Louis, Missouri Annie Dirks - (aplatts@wustl.edu) Lesley Alexander - (alesley@wustl.edu)
Yale University New Haven, Connecticut Cinthia S De Freitas - (cinthia.defreitas@yale.edu)

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps (FORTE)

Director, Department of Regulatory Affairs - langerj@nrgoncology.org

NCT05080673
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Inclusion Criteria:
* The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish.
Exclusion Criteria:
* • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size. * Traditional serrated adenomas found on the qualifying colonoscopy. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy. * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization. * Incomplete qualifying colonoscopy (e.g., cecum not visualized). * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.) * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.) * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]). * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis). * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.
PROCEDURE: 5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
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Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
AdventHealth Littleton Littleton, Colorado
AdventHealth Parker Parker, Colorado
AdventHealth Porter Denver, Colorado
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
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Alta Bates Summit Medical Center - Summit Campus Oakland, California
Altru Cancer Center Grand Forks, North Dakota
Ann M Wierman MD LTD Las Vegas, Nevada
Armes Family Cancer Center Findlay, Ohio
Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin
Ascension Calumet Hospital-Chilton Chilton, Wisconsin
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin
Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin
Ascension Saint Francis Hospital-Milwaukee Milwaukee, Wisconsin
Ascension Southeast Wisconsin Hospital - Franklin Franklin, Wisconsin
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin
Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee Milwaukee, Wisconsin
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Audie L Murphy VA Hospital San Antonio, Texas
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
BASS Medical Group - Lennon Walnut Creek, California
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Bay Area Breast Surgeons Inc Emeryville, California
Bay Area Tumor Institute Oakland, California
Bay Pines VA Healthcare System Bay Pines, Florida Site Public Contact - (vhabayresearch@va.gov)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Beaufort Memorial Hospital Beaufort, South Carolina Site Public Contact - (kwade@bmhsc.org)
Benefis Helena Specialty Center Helena, Montana Site Public Contact - (mccinfo@mtcancer.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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
Boston Veteran's Affairs Medical Center Jamaica Plain, Massachusetts Site Public Contact - (ctsucontact@westat.com)
Boulder Community Foothills Hospital Boulder, Colorado
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)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Health Saint Francis Grand Island, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CHI Saint Vincent Cancer Center Hot Springs Hot Springs, Arkansas
CTCA at Western Regional Medical Center Goodyear, Arizona
Cambridge Medical Center Cambridge, Minnesota
Camden Clark Medical Center Parkersburg, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer Center-Metro Medical Center Bayamon Bayamón,
Cancer and Blood Specialists-Henderson Henderson, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois
Carle Physician Group-Effingham Effingham, Illinois
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois
Carle at The Riverfront Danville, Illinois
Carson Tahoe Regional Medical Center Carson City, Nevada Site Public Contact - (research@sncrf.org)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.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)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (Roster@nrgoncology.org)
Colorado Blood Cancer Institute Denver, Colorado
CommonSpirit Cancer Center Mercy Durango, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Anthony Hospital Cancer Center Lakewood, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Bardstown Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital - Lexington Lexington, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital London London, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Hospital Mount Sterling Mount Sterling, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
CommonSpirit Saint Joseph Medical Center - East Lexington Lexington, Kentucky 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 Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (cancerresearch@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)
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)
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 Grand Rapids Hospitals - Helen DeVos Children's 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)
Cotton O'Neil Cancer Center / Stormont Vail Health Topeka, Kansas
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC - Troy Troy, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Dayton Physicians LLC-Miami Valley South Centerville, Ohio
Dayton Physicians LLC-Wayne Greenville, Ohio
Doctors Cancer Center Manati,
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care Partners in Cancer Care Emeryville, California
Epic Care-Dublin Dublin, California
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Saint Joseph's Crosslake Clinic Crosslake, Minnesota
Essentia Health - Saint Joseph's Pequot Lakes Clinic Pequot Lakes, Minnesota
Essentia Health - Saint Joseph's Pine River Clinic Pine River, Minnesota
Essentia Health - Saint Joseph's Staples Clinic Staples, 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 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)
FPG - Surgical Oncology Clinics Gastrointestinal Oncology Surgery Sarasota, Florida Site Public Contact - (Research-Institute@smh.com)
Fairbanks Memorial Hospital Fairbanks, Alaska
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 Physicians Group - Gastroenterology Obesity Medicine Sarasota, Florida
Franciscan Research Center-Northwest Medical Plaza Tacoma, Washington
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Gastro Health - Galloway Miami, Florida Site Public Contact - (jleavitt@gastrohealth.com)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Center-Cancer Center Hazleton Hazleton, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah
George Washington University Medical Center Washington D.C., District of Columbia
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 Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Greater Dayton Cancer Center Kettering, Ohio
Greater Regional Medical Center Creston, Iowa
HIMA San Pablo Oncologic Hospital Caguas,
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii
Health Partners Inc Minneapolis, Minnesota
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (Roster@nrgoncology.org)
Highline Medical Center-Main Campus Burien, Washington
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)
Idaho Urologic Institute-Meridian Meridian, Idaho
Indu and Raj Soin Medical Center Beavercreek, Ohio
Instituto Oncologia Moderna Ponce Ponce,
Jefferson Healthcare Port Townsend, Washington
Jewish Hospital Louisville, Kentucky
Jewish Hospital Medical Center South Shepherdsville, Kentucky
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kaiser Permanente - Kensington Medical Center Kensington, Maryland Site Public Contact - (Charmaine.A.Mckie@kp.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 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 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-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-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Franklin Denver, Colorado Site Public Contact - (KPCOIHRClinicalResearch@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 Site Public Contact - (KPCOIHRClinicalResearch@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Rio San Diego San Diego, 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 Site Public Contact - (KPCOIHRClinicalResearch@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Vallejo Vallejo, 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)
Kansas City Veterans Affairs Medical Center Kansas City, Missouri
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kettering Medical Center Kettering, Ohio
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.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)
Kuakini Medical Center Honolulu, Hawaii
LSU Health Sciences Center at Shreveport Shreveport, Louisiana Site Public Contact - (LPost@lsuhsc.edu)
Labette Health Parsons, Kansas
Lake Region Healthcare Corporation-Cancer Care Fergus Falls, Minnesota
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Las Vegas Prostate Cancer Center Las Vegas, Nevada
Las Vegas Urology - Cathedral Rock Las Vegas, Nevada
Las Vegas Urology - Green Valley Henderson, Nevada
Las Vegas Urology - Pebble Henderson, Nevada
Las Vegas Urology - Pecos Las Vegas, Nevada
Las Vegas Urology - Smoke Ranch Las Vegas, Nevada
Las Vegas Urology - Sunset Las Vegas, Nevada
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)
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Louis Stokes Cleveland VA Medical Center Cleveland, Ohio Site Public Contact - (holly.henry@va.gov)
Louisiana State University Health Science Center New Orleans, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Lovelace Medical Center-Saint Joseph Square Albuquerque, New Mexico
Low Country Cancer Care Savannah, Georgia
Loyola University Medical Center Maywood, Illinois
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Malcom Randall Veterans Administration Medical Center Gainesville, Florida Site Public Contact - (trials@cancer.ufl.edu)
Marshfield Clinic-Wausau Center Wausau, 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 - 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)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic in Rochester Rochester, Minnesota
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital of Laramie County Cheyenne, Wyoming Site Public Contact - (Roster@nrgoncology.org)
Mercy Cancer Center Merced, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Health - Paducah Cancer Center Paducah, Kentucky
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 Pittsburg Pittsburg, Kansas
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
Mercy Medical Center-West Lakes West Des Moines, Iowa
Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (ResearchInstituteInquiries@commonspirit.org)
Mercyhealth Cancer Institute - Rockford Rockford, Illinois Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.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)
Midlands Community Hospital Papillion, Nebraska
Midwestern Regional Medical Center Zion, Illinois
Miller-Dwan Hospital Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Minneapolis VA Medical Center Minneapolis, Minnesota
Minnesota Oncology - Burnsville Burnsville, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Coon Rapids Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Edina Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology - Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Minnesota Oncology Hematology PA-Chaska Chaska, 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)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida Site Public Contact - (yenrique@msmc.com)
Mount Sinai Medical Center New York, New York Site Public Contact - (Yvonne.Enriquez@msmc.com)
Mountain Blue Cancer Care Center - Swedish Englewood, Colorado
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island, Nebraska
New Ulm Medical Center New Ulm, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
North Grove Medical Park Spartanburg, South Carolina
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)
Northwest Cancer Center - Crown Point Crown Point, Indiana
Northwest Cancer Center - Hobart Hobart, Indiana
Northwest Cancer Center - Valparaiso Valparaiso, Indiana
Northwest Oncology LLC Dyer, Indiana
Northwest Wisconsin Cancer Center Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Northwestern University Chicago, Illinois
OSF Saint Anthony's Health Center Alton, Illinois
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio
Oncology Las Vegas - Henderson Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oncology Las Vegas - Tenaya Las Vegas, Nevada Site Public Contact - (research@sncrf.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)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Orion Cancer Care Findlay, Ohio
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
PROncology San Juan, Site Public Contact - (info@PRoncology.com)
Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Pali Momi Medical Center ‘Aiea, Hawaii
Pan American Center for Oncology Trials LLC San Juan, Site Public Contact - (marcia.cruzcorrea@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)
Pan American Center for Oncology Trials LLC - Manati Manati, Site Public Contact - (info@panoncologytrials.com)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.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)
Piedmont Hospital Atlanta, Georgia
Portland VA Medical Center Portland, Oregon
Premier Blood and Cancer Center Dayton, Ohio
Presbyterian - Saint Lukes Medical Center - Health One Denver, Colorado
Primary Care Physician Group San Juan,
Princeton Community Hospital Princeton, West Virginia
Prisma Health Greenville Memorial Hospital Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Providence Veterans Administration Hospital Providence, Rhode Island
Puerto Rico Hematology Oncology Group Bayamón,
Queen's Cancer Center - Kuakini Honolulu, Hawaii
Queen's Cancer Center - Pearlridge ‘Aiea, Hawaii
Queen's Medical Center Honolulu, Hawaii
Radiation Oncology Associates Reno, Nevada
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)
Ralph H Johnson VA Medical Center Charleston, South Carolina Site Public Contact - (ashley.salvo@va.gov)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana
Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Riverwood Healthcare Center Aitkin, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Robert J Dole VA Medical Center Wichita, Kansas
Rocky Mountain Cancer Centers - Centennial Centennial, Colorado
Rocky Mountain Cancer Centers - Swedish Englewood, Colorado
Rocky Mountain Cancer Centers-Aurora Aurora, Colorado
Rocky Mountain Cancer Centers-Boulder Boulder, Colorado
Rocky Mountain Cancer Centers-Lakewood Lakewood, Colorado
Rocky Mountain Cancer Centers-Littleton Littleton, Colorado
Rocky Mountain Cancer Centers-Longmont Longmont, Colorado
Rocky Mountain Cancer Centers-Midtown Denver, Colorado
Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Rocky Mountain Cancer Centers-Rose Denver, Colorado
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree, Colorado
Rocky Mountain Cancer Centers-Thornton Thornton, Colorado
Rocky Mountain Regional VA Medical Center Aurora, Colorado
Rush MD Anderson Cancer Center Chicago, Illinois
Rush-Copley Healthcare Center Yorkville, Illinois
Rush-Copley Medical Center Aurora, Illinois
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)
Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon
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 Anthony North Hospital Westminster, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Catherine Hospital Indianapolis, Indiana
Saint Clare Hospital Lakewood, Washington
Saint Elizabeth Boardman Hospital Boardman, Ohio
Saint Elizabeth Healthcare Edgewood Edgewood, Kentucky Site Public Contact - (Kristi.Curtsinger@stelizabeth.com)
Saint Elizabeth Healthcare Fort Thomas Fort Thomas, Kentucky
Saint Elizabeth Hospital Enumclaw, Washington
Saint Elizabeth Regional Medical Center Lincoln, Nebraska
Saint Elizabeth Youngstown Hospital Youngstown, Ohio
Saint Francis Cancer Center Colorado Springs, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Francis Hospital Federal Way, Washington
Saint Francis Regional Medical Center Shakopee, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint John's Hospital - Healtheast Maplewood, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Saint Joseph Medical Center Hematology and Oncology - Silverdale Silverdale, Washington 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
Saint Joseph's Medical Center Stockton, California
Saint Luke's Cancer Center - Allentown Allentown, Pennsylvania
Saint Luke's Hospital - Monroe Campus Stroudsburg, Pennsylvania Site Public Contact - (Roster@nrgoncology.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 Corwin Medical Center Pueblo, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Saint Mary Medical Center Hobart, Indiana
Saint Mary's Hospital Centralia, Illinois
Saint Mary's Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, 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)
Saints Mary and Elizabeth Hospital Louisville, Kentucky
San Juan City Hospital San Juan,
San Juan Community Oncology Group San Juan,
San Juan Veterans Affairs Medical Center San Juan, Site Public Contact - (sajresearchcontactus@va.gov)
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)
Sarasota Memorial Health Care Center at University Parkway Sarasota, Florida
Sarasota Memorial Hospital Sarasota, Florida
Sarasota Memorial Hospital-Venice N. Venice, Florida
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)
Southpointe-Sanford Medical Center Fargo Fargo, North Dakota
Sovah Health Martinsville Martinsville, Virginia
Spartanburg Medical Center Spartanburg, South Carolina Site Public Contact - (kmertz-rivera@gibbscc.org)
Spartanburg Medical Center - Mary Black Campus Spartanburg, South Carolina
Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (cancertrialsinfo@stanford.edu)
Straub Clinic and Hospital Honolulu, Hawaii
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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Tamarack Health Hayward Medical Center Hayward, Wisconsin
The Carle Foundation Hospital Urbana, Illinois
The Community Hospital Munster, Indiana
The Melanoma and Skin Cancer Institute Englewood, Colorado
The Women's Imaging Center Denver, Colorado
TriHealth Cancer Institute-Anderson Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
TriHealth Cancer Institute-Westside Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
UCHealth University of Colorado Hospital Aurora, Colorado
UCLA / Jonsson Comprehensive Cancer Center Los Angeles, California
UHHS-Chagrin Highlands Medical Center Beachwood, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
UHHS-Westlake Medical Center Westlake, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
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
UPMC-Presbyterian Hospital Pittsburgh, Pennsylvania
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas
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United Hospital Center Bridgeport, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)
Unity Hospital Fridley, Minnesota
University Cancer Center Las Vegas, Nevada
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University of Arizona Cancer Center - Prevention Research Clinic Tucson, Arizona Site Public Contact - (pcarino@arizona.edu)
University of Cincinnati Cancer Center-UC Medical Center Cincinnati, Ohio
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University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
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University of Michigan Rogel Cancer Center Ann Arbor, Michigan
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UofL Health Medical Center Northeast Louisville, Kentucky
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Urology Specialists of Nevada - Central Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven, Connecticut
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William S Middleton VA Medical Center Madison, Wisconsin
Women's Cancer Center of Nevada Las Vegas, Nevada
Women's Diagnostic Center - Munster Munster, Indiana
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Yale-New Haven Hospital Saint Raphael Campus New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin

Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

Clinical Trials Administrator - clinicaltrials@regeneron.com

NCT03564340
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Key
Inclusion Criteria:

• Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
• serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening, not required for low-grade serous carcinoma)
• has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
• documented relapse or progression on or after the most recent line of therapy
• no standard therapy options likely to convey clinical benefit
• Adequate organ and bone marrow function as defined in the protocol
• Life expectancy of at least 3 months
• Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 2 to 4 lines of platinum-based therapy as defined in the protocol.
• Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:
• MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC), as defined in the protocol
• 1-4 prior lines of systemic therapy, as described in the protocol Key
Exclusion Criteria:

• Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
• Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy (does not apply to low-grade serous ovarian cancer cohort)
• Prior treatment with a MUC16 - targeted therapy
• Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
• History and/or current cardiovascular disease, as defined in the protocol
• Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen Note: Other protocol-defined Inclusion/Exclusion Criteria apply
DRUG: Ubamatamab, DRUG: Cemiplimab, DRUG: Sarilumab, DRUG: Tocilizumab
Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Recurrent Endometrial Cancer, Endometrial Cancer, Low-grade Serous Ovarian Cancer
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Location Contacts
Asan Medical Center, Univ. of Ulsan Seoul,
Centre Antoine Lacassagne Nice,
Centre Francois Baclesse (CFB) Caen, Normandy
Centre Georges Francois Leclerc Dijon, Côte-d'Or
Clinica Universidad Navarra (CUN) Madrid Madrid,
Clinica Universidad de Navarra Madrid,
Columbia University Medical Center New York, New York
Dana Farber / Harvard Cancer Center Boston, Massachusetts
Erasmus MC Rotterdam,
Fondazione Policlinico Universitario Agostino Gemelli Irccs Rome,
Fundacion Jimenez Diaz Madrid,
Grand Hopital de Charleroi Charleroi, Hainaut
Guys Hospital London,
Hopital Lyon Sud Pierre-Bénite,
Hospital Clinico Universitatio Santiago de Compostela Santiago de Compostela,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario San Carlos Madrid,
Humanitas S. Pio X Milan,
Imperial College Healthcare NHS Trust London, Greater London
Institut Bergonie Bordeaux,
Institut Catala d'Oncologia Barcelona,
Institut Catala dOncologia Badalona Badalona,
Institut Gustave Roussy Villejuif,
Instituto Nazionale Tumori- Fondazione Pascale Naples,
Istituto Europeo Di Oncologia Milan,
Korea University Guro Hospital Seoul, Guro-gu
Massachusetts General Hospital Boston, Massachusetts
Mayo Clinic - Rochester Rochester, Minnesota
Memorial Sloan Kettering Cancer Center New York, New York
Peter MacCallum Cancer Center Melbourne,
Prince of Wales Hospital Shatin,
Radboudumc Nijmegen,
Rambam Health Care Campus Haifa,
Roswell Park Cancer Institute Buffalo, New York
Royal Marsden Hospital - Sutton Sutton, Surrey
Samsung Medical Center Seoul,
Sarah Cannon Research Institute Denver, Colorado
Seoul National University Hospital Seoul,
Sharet Institute of Oncology Jerusalem,
Sheba Medical Center Ramat Gan,
Stephenson Cancer Center Oklahoma City, Oklahoma
The Christie NHS Foundation Trust Manchester, Lancashire
The Ohio State University Wexner Medical Center Columbus, Ohio
The Royal Marsden NHS Foundation Trust London,
UZLeuven Leuven, Vlaams-Brabant
Universitair Ziekenhuis Antwerpen Edegem,
University College London Hospitals London,
University Medical Center Groningen Groningen,
University of Alabama_6th Ave Birmingham, Alabama
University of Oxford Oxford, Oxfordshire
Virginia Commonwealth University Richmond, Virginia
Yonsei University Health System Seoul,

Psychobiological Responses Following Exercise and Brain Stimulation

Edmund Acevedo - eoacevedo@vcu.edu

NCT06874595
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Inclusion Criteria:
* Healthy adults * aged 18 to 50 * consent and complete a Physical Activity Readiness Questionnaire (PAR-Q) * be free from any neurological or psychiatric disorder * not be taking any medication that could affect the central nervous system * not have any contraindication for HD-tDCS (i.e. not having metal implanted in the head, pacemaker, medical bumps, seizures, lesions on the scalp or head ) or for bioelectrical impedance (i.e., electronic medical implant, such as a pacemaker or implantable cardioverter defibrillator, and limb amputation) * not be regular users of tobacco products (cigarettes, cigars, chewing tobacco) * not consume an average of more than ten alcoholic beverages per week
Exclusion Criteria:
* Individuals who do not meet the PAR-Q screening criteria for participation in moderate physical activity will be excluded from participating in this study * women who are pregnant will be exclude from this study
OTHER: Cycling exercise at 65% of HRR for 20 minutes followed by HD-tDCS (exercise + HD-tDCS), OTHER: Cycling exercise at 65% of HRR exercise followed by sham HD-tDCS (exercise + sham tDCS), OTHER: No exercise followed by HD-tDCS (no exercise + HD-tDCS)., OTHER: State Anxiety Inventory, OTHER: Visual Analog Scale for Anxiety
Psychological
Exercise and Brain Stimulation
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Virginia Commonwealth University Richmond, Virginia Edmund Acevedo, PhD - (eoacevedo@vcu.edu)

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Joseph T Hull, PhD - jhull@supernus.com

NCT04781140
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Inclusion Criteria:

• Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.
• Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.
• Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.
• Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study).
• Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.
• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
Exclusion Criteria:

• Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.
• Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.
• Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).
• Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).
• Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).
DRUG: 100mg SPN-812, DRUG: Placebo
Attention-Deficit/Hyperactivity Disorder
ADHD
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AIM Trials, LLC Plano, Texas - (info@aimtrials.com)
APG Research LLC Orlando, Florida - (kkenworthyapg@gmail.com)
Advanced Discovery Research LLC Atlanta, Georgia - (contact@advdiscovery.com)
Advanced Research Center (ARC), Inc. Anaheim, California - (contact@arctrials.com)
Alliance Research Long Beach, California - (Research@asclepes.com)
Avantis Clinical Research LLC Miami, Florida - (info@avantisclinicalresearch.com)
Boston Children's Hospital Boston, Massachusetts - (benamin.mills@childrens.harvard.edu)
CenExcel iResearch, LLC Decatur, Georgia
CenExel iResearch, LLC. Savannah, Georgia
Cincinnati Children's Hospital and Medical Center Cincinnati, Ohio - (ADHDResearch@cchmc.org)
CincyScience West Chester, Ohio - (research@cincyscience.com)
Clinical Integrative Research Center of Atlanta Atlanta, Georgia
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee - (orlinfo@cnshealthcare.com)
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical Research Partners, LLC Petersburg, Virginia - (Recruitment@ClinicalResearchRVA.com)
Clinical Research of Southern Nevada, LLC. Las Vegas, Nevada - (kluna.cpbm@gmail.com)
Coastal Carolina Research Center North Charleston, South Carolina - (CCRC@CoastalCarolinaResearch.com)
Coastal Pediatric Research Summerville, South Carolina - (info.research@cpakids.com)
Cyn3rgy Research Gresham, Oregon - (support@cyn3rgy.com)
D&H Tamarac Research Center Tamarac, Florida - (info@dhnrc.com)
DelRicht Research Prairieville, Louisiana - (info@delricht.com)
DelRicht Research (Touro Medical Center) New Orleans, Louisiana - (info@delricht.com)
Duke University Durham, North Carolina
Family Psych of The Woodlands The Woodlands, Texas - (info@woodlandspsych.com)
Hope Research Network, LLC. Miami, Florida - (info@hoperesearchnetwork.com)
Houston Clinical Trials, LLC. Bellaire, Texas
IMMUNOe Research Centers Centennial, Colorado - (verosinfo@veroshealth.com)
Icahn School of Medicine at Mount Sinai New York, New York - (adhd.research@mssm.edu)
Javara Dallas, Texas
Jersey Shore University Medical Center Neptune City, New Jersey - (andrew.layman@hmhn.org)
Kennedy Krieger Institute Baltimore, Maryland
Kentucky Pediatric/Adult Research Bardstown, Kentucky - (kpar@kpar.us)
Luna Research Center Coral Gables, Florida
Med Clinical Research Irvington, New Jersey - (info@medclinicalresearch.com)
Medical Research Group of Central Florida Orange City, Florida
Neurobehavioral Medicine Group Bloomfield Hills, Michigan - (info@neurobmg.com)
Pediatric Neurology and Epilepsy Specialists Winter Park, Florida - (ARiveraDelValle@pediatricneurologyandepilepsy.com) - (DHubert@pediatricneurologyandepilepsy.com)
Penn State Health Medical Group - Psychiatry and Behavioral Health Hershey, Pennsylvania - (rmyers12@pennstatehealth.psu.edu)
Precise Research Centers Flowood, Mississippi
Preferred Research Partners, Inc. Little Rock, Arkansas - (info@preferredresearchpartners.com)
Qualmedica Research, LLC. Owensboro, Kentucky
Qualmedica Research, LLC. Owensboro, Kentucky
Sarkis Clinical Trials Gainesville, Florida
Sun Valley Research Center Imperial, California - (svrcinfo@sunvalleyb.com)
The Center for Clinical Trials, Inc. Saraland, Alabama - (info@thecenterforclinicaltrials.com)
Virginia Commonwealth University, Virginia Treatment Center for Children Richmond, Virginia