Current Clinical Trials | Norton Healthcare Louisville, Ky.

Current Clinical Trials

Compassionate Use of Coated IPG (Medtronic Azure S DR MRI IPG 100% Parylene Coated)
Study Type: Device Study
Kevin Thomas M.D.
Kevin Thomas, M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Medtronic

Acute Coronary Syndrome (ACS)

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome
Study Type: Drug Study
Vipul Panchal  M.D.
Vipul Panchal M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: CSL Behring LLC

Acute Respiratory Illness

Quantifying the Under-Ascertainment of RSV Infections Among Hospitalized Adults 40 and Older Based on RT-PCR Testing of Nasopharyngeal Swabs — North America Multispecimen Study
Study Type: Specimen Study
Julio Ramirez, M.D.
Julio Ramirez, M.D.
Principal Investigator
Norton Infectious Diseases Institute
Sponsor: Pfizer

Advanced Malignancies

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BicycleTx Limited

Advanced Malignancies

An open-label, multicenter Phase I dose escalation study to characterize safety, tolerability, preliminary antitumor activity, pharmacokinetics and maximum tolerated dose of VIP152 (BAY 1251152) in subjects with advanced cancer
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Vincerx Pharma, Inc

Advanced Malignancies

A PHASE 1B OPEN-LABEL DOSE ESCALATION TRIAL OF THE SAFETY OF, AND ANTIGEN-SPECIFIC IMMUNE RESPONSES ELICITED BY, VB10.NEO IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC TUMORS
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Vaccibody AS

Advanced Malignancies

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination with AB122 in Participants with Advanced Malignancies
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Arcus Biosciences, Inc.

Advanced Solid Tumors

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination with Budigalimab and/or Chemotherapy in Subjects with Advanced Solid Tumors
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Trishula Therapeutics, Inc.

Advanced Solid Tumors

First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of GEN1046 in subjects with malignant solid tumors
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Genmab

Advanced Solid Tumors

A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Astellas Pharma Global Development Inc.

Advanced Solid Tumors

An Open-Label Study of ALPN-202 in Subjects with Advanced Malignancies (NEON-1)
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Alpine Immune Sciences, Inc.

Advanced Solid Tumors

A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Tizona Therapeutics, Inc.

Advanced Solid Tumors

A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Seattle Genetics, Inc

Advanced Solid Tumors

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Subjects with Advanced or Metastatic Solid Tumors with KRasG12C Mutation
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: InventisBio US

Advanced Solid Tumors

A Phase 1/2 Dose Escalation And Dose Expansion Study Of Ba3011 Alone And In Combination With Nivolumab In Adult And Adolescent Patients 12 Years And Older With Advanced Solid Tumors
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioAtla LLC

Advanced Solid Tumors

A Phase 1, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of the WEE1 Inhibitor IMP7068 Monotherapy in Patients with Advanced Solid Tumors (MISC 21-07)
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Impact Therapeutics

Advanced Solid Tumors

Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Ascendis Pharma

Advanced Solid Tumors

A PHASE 1/2 DOSE ESCALATION AND DOSE EXPANSION STUDY OF BA3021 ALONE AND IN COMBINATION WITH NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioAtla LLC

Advanced Solid Tumors

Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB Study
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: OncoC4, Inc

Alzheimer’s

Alzheimer’s Disease and Related Disorders Memory Center Recruitment Database
Study Type: Registry
Greg Cooper, M.D.,Ph.D.
Greg Cooper, M.D.,Ph.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: NH Investigator

Alzheimer’s Disease

A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
Study Type: Drug Study
Greg Cooper, M.D.,Ph.D.
Greg Cooper, M.D.,Ph.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: Eli Lilly

Aneurysms

STERLING REGISTRY - A Prospective, Multi-Center, Single Arm, Study to obtain “real world” clinical data and characterize the acute & long term performance of the Micrusframe & Galaxy Coils for the Endovascular treatment of Intracranial Aneurysms
Study Type: Device Study
Tom Yao  M.D.
Tom Yao M.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: Cerenovus, Part of Depuy Synthes Products, Inc

Arthritis

Proximal Inter Phalangeal Finger Joint Prosthesis
Study Type: Device Study
Ethan Blackburn M.D.
Ethan BlackburnM.D.
Principal Investigator
Norton Louisville Arm & Hand
Sponsor: Stryker

Atrial Arrhythmias

Tracking Results of Ablations to Combat AF Registry (Formerly the Maze IV Registry)
Study Type: Registry
Kent Morris  M.D.
Kent Morris M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: AtriCure Inc

Atrial Fibrillation

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the Management of Patients with Non-Valvular Atrial Fibrillation
Study Type: Device Study
Kent Morris  M.D.
Kent Morris M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Boston Scientific

Atrial Fibrillation

Real-world Experience of Catheter Ablation for the Treatment of Symptomatic Paroxysmal and Persistent Atrial Fibrillation Using Novel Contact Force Technologies: REAL AF Registry
Study Type: Registry
Kent Morris  M.D.
Kent Morris M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

B-Cell Malignancies

A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BeiGene, Ltd

B-Cell Non-Hodgkin Lymphoma

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Teneobio, Inc.

Bladder Cancer

A Phase Ib/II Open Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Locally Advanced Or Metastatic Urothelial Carcinoma After Failure With Platinum-Containing Chemotherapy (MORPHEUS-mUC)
Study Type: Drug Study
Chandler Park  M.D.
Chandler Park M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: F. Hoffmann-LaRoche Ltd.

Bladder Cancer

A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma
Study Type: Drug Study
Chandler Park  M.D.
Chandler Park M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Mirati Therapeutics, Inc

Bladder Cancer

A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer after Failure of Platinum-Based Regimen or Anti-PD-1/ PD-L1 Based Immunotherapy
Study Type: Drug Study
Chandler Park  M.D.
Chandler Park M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Immunomedics, Inc

Blood and Tumor Collection

Detecting cancers Earlier Through Elective plasma-based CancerSEEK Testing – Ascertaining Serial Cancer patients to Enable New Diagnostic II (DETECT-ASCEND 2)
Study Type: Specimen Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Exact Sciences Corporation

Breast Cancer

Collection of sentinel lymph node tissue, blood, urine and saliva from those undergoing surgery for melanoma or breast cancer for the purpose of research now and in the future.
Study Type: Specimen Study
Kelly McMasters M.D.
Kelly McMasters M.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: UofL Investigator

Cancer

Evaluation of Biomarkers as a Predictor of Cancer and Healing
Study Type: Specimen Study
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: UofL Investigator

Cardiovascular Disease

ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
Study Type: Drug Study
Jason A. Hopper M.D.
Jason A. Hopper M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Novo Nordisk, Inc.

Coronary Artery Disease

The REVEALPLAQUE Study: A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA
Study Type: Registry
Steven Raible  M.D.
Steven Raible M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: HeartFlow, Inc

COVID

A PHASE 1 STUDY OF AGENT-797 TO TREAT MODERATE TO SEVERE ACUTE RESPIRATORY SYNDROME IN COVID 19 PATIENTS
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Agentus Therapeutics

COVID-19 Infection

COViMS (COVID-19 Infections in MS & Related Diseases) is a joint effort of the US National MS Society and the Consortium of MS Centers to capture information on outcomes of people with MS and other CNS demyelinating diseases (Neuromyelitis Optica Spectrum Disease, or MOG antibody disease) who have developed COVID-19
Study Type: Registry
Geeta Ganesh  M.D.
Geeta Ganesh M.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: US National MS Society / Consortium of MS Centers

COVID-19 Infection

A Phase 2, Open label Randomized Study of the Efficacy and Safety of Acalabrutinib (a BTK inhibitor) with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

COVID-19 Infection

Prospective Blood and Tissue Sample Collections in Symptomatic and Asymptomatic Pregnant Women During the COVID-19 Pandemic Period
Study Type: Specimen Study
Helen How M.D.
Helen How, M.D.
Principal Investigator
Maternal Fetal Medicine
Sponsor: NH Investigator

Degenerative Disc Disease

An Assessment of P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion with Instrumentation
Study Type: Device Study
Mladen Djurasovic  M.D.
Mladen Djurasovic M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: Cerapedics, Inc

Dementia

New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study - A Study to Improve Precision in Amyloid PET Coverage and Patient Care
Study Type: Observational
Greg Cooper, M.D.,Ph.D.
Greg Cooper, M.D.,Ph.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: American College of Radiology

Diffuse Large B-Cell Lymphoma

A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newlydiagnosed diffuse large B-cell lymphoma (DLBCL) [frontMIND]
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: MorphoSys AG

Education

Effects of a Smartphone App on Compliance and Function in Patients with Breast Cancer
Study Type: Observational
Joseph Flynn, D.O.
Joseph Flynn, D.O., MPH, FACP
Principal Investigator
Norton Cancer Institute
Sponsor: NH Investigator

Endometrial Cancer

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination with Adjuvant Chemotherapy with or without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Carcinoma After Surgery with Curative Intent (MK3475 B21/ENGOT-en11/GOG-3053)
Study Type: Drug Study
Mary Gordinier  M.D.
Mary Gordinier M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck Sharp & Dohme CORP

Epilepsy

PENSAR: PatiEnt Neuropsychological outcomeS After laseR ablation
Study Type: Registry
Bradley Folley, Ph.D.
Bradley Folley, PhD
Principal Investigator
Norton Neuroscience Institute
Sponsor: Monteris Medical Corporation

Esophageal Cancer

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center International Study of Durvalumab Given Concurrently with Definitive Chemoradiation Therapy in Patients with Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma
Study Type: Drug Study
Michael Driscoll  M.D.
Michael Driscoll M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

Gastric Cancer

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant/Adjuvant Durvalumab and Standard Chemotherapy Followed by Adjuvant Durvalumab in Patients with Resectable Gastric and astroesophageal Cancer (GC/GEJC)
Study Type: Drug Study
Michael Driscoll  M.D.
Michael Driscoll M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

Gastric Cancer

A randomized, double-blind, placebo-controlled, active comparator Phase 2/3 study of tucatinib in combination with trastuzumab, ramucirumab, and paclitaxel in subjects with previously treated, locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)
Study Type: Drug Study
Michael Driscoll  M.D.
Michael Driscoll M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Seattle Genetics, Inc

Glioblastoma

EF-32 (TRIDENT): A Pivotal Randomized, Open-Label Study of Optune® (TTFields, 200khz) Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
Study Type: Device Study
Renato LaRocca  M.D.
Renato LaRocca M.D.
Principal Investigator
Norton Brain Tumor Center
Sponsor: NovoCure

Glioblastoma

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1
Study Type: Drug Study
Kaylyn Sinicrope, M.D.
Kaylyn Sinicrope, M.D.
Principal Investigator
Norton Brain Tumor Center
Sponsor: Denovo Biopharma LLC

Glioma

NCCTG N0577/Endorsed Study: Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma
Study Type: Drug Study
Aaron Spalding  M.D.
Aaron Spalding M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Radiation Therapy Oncology Group (RTOG)

Head and Neck Cancer

Phase II, Open-Label, Multi-Center Study of PDS0101 (ImmunoMAPK-RDOTAP/HPV-16 E6 & E7 peptides) and Pembrolizumab (KEYTRUDA) Combination Immunotherapy as a First Line Treatment in Subjects with Recurrent and/or Metastatic Head and Neck Cancer (HNSCC) and High-risk Human Papillomavirus-16 (HPV16) Infection
Study Type: Drug Study
Jaspreet Grewal M.D.
Jaspreet GrewalM.D.
Principal Investigator
Norton Cancer Institute
Sponsor: PDS Biotechnology Corporation

Head and Neck Cancer

An open label Phase II randomized trial of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first line therapy in patients with unresectable recurrent, or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) which is positive for human papilloma virus 16 (HPV16+) and expresses PD-L1
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioNTech RNA Pharmaceuticals GmbH

Heart Failure

Product Surveillance Registry / Site 10123001
Study Type: Registry
Robert Schwartz  M.D.
Robert Schwartz M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Medtronic

Hematological Malignancies

A Phase 1, Multicenter, Open-label, Multiple-ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of KPG-818 in Combination with SOC Therapies in Subjects with Relapsed and Refractory Hematological Malignancies.
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Kangpu Biopharmaceuticals

Hematological Malignancies

A Phase 1a/1b Dose-Escalation and Expansion Trial of TTI-622 in Patients with Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Trillium Therapeutics Inc.

Hepatocellular Carcinoma (HCC)

A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
Study Type: Drug Study
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: Merck Sharp & Dohme LLC

HER2- Locally Advanced Metastatic Breast Cancer

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib In Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced Or Metastatic Breast Cancer
Study Type: Drug Study
Jeffrey Hargis  M.D.
Jeffrey Hargis M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: F. Hoffmann-LaRoche Ltd.

HER2+ Early Stage Breast Cancer

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast 11)
Study Type: Drug Study
Laila Agrawal  M.D.
Laila Agrawal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

HER2+ Unresectable or Metastatic

Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)
Study Type: Drug Study
Laila Agrawal  M.D.
Laila Agrawal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

HR Positive

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
Study Type: Drug Study
Laila Agrawal  M.D.
Laila Agrawal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biological Activity, and PK of ND-L02-s0201 In Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Nitto Denko Corporation

Kidney Cancer

An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck Sharp & Dohme CORP

Leukemia

Extended treatment protocol for subjects continuing to benefit from Ibrutinib after completion of Ibrutinib (PCI-32965) clinical trials.
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Pharmacyclics, LLC

Leukemia

Tagraxofusp (SL-401) in Patients with Chronic Myelomonocytic Leukemia (CMML) or Myelofibrosis (MF)
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Stemline Therapeutics, Inc

Leukemia

An Open-label, Multicenter, Phase 1b Study of JNJ-74494550 (Cusatuzumab; Anti-CD70 Monoclonal Antibody) in Combination with Background Therapy for the Treatment of Subjects with Acute Myeloid Leukemia
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Janssen Research & Development

Leukemia

A Phase 1 Study of Safety, Pharmacokinetics, and Preliminary Activity of TAS1440, as a Single Agent and in Combination with All-Trans Retinoic Acid (ATRA) in Subjects with Relapsed or Refractory (r/r) Acute Myeloid Leukemia (AML)
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Astex Pharmaceuticals

Leukemia

A Phase 1 Study of Safety, Pharmacokinetics and Preliminary Activity of TAS1553 in Subjects with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Astex Pharmaceuticals

Leukemia

A Phase I/II open label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of ONO-7475 in patients with acute leukemias or myelodysplastic syndromes
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: ONO Pharmaceutical Co., Ltd.

Leukemia

A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator’s Choice of Idelalisib plus Rituximab or Bendamustine plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Loxo Oncology

Leukemia

A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination with Azacitidine and/or Venetoclax in Subjects with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AbbVie

Lumbar Degenerative Spondylolisthesis

A Concurrently Controlled Study of the LimiFlex™ Paraspinous Tension Band in the Treatment of Lumbar Degenerative Spondylolisthesis with Spinal Stenosis
Study Type: Device Study
Jeffrey Gum  M.D.
Jeffrey Gum M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: Empirical Spine, Inc.

Lumbar Fusion Surgery

Detection of Spinal implants at airport security checkpoints - how do updated security measures affect patients?
Study Type: Questionnaire
Charles Crawford, M.D.
Charles Crawford, M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: NH Investigator

Lumbar Fusion Surgery

Impact of Dronabinol on Post-operative Pain After Lumbar Fusion for Degenerative Disorders of the Spine
Study Type: Drug Study
Jeffrey Gum  M.D.
Jeffrey Gum M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: NH Investigator

Lumbar Surgery

Patient Expectations and Patient Reported Outcomes in Lumbar Spine Surgery
Study Type: Questionnaire
Steven Glassman  M.D.
Steven Glassman M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: NH Investigator

Lung Cancer

Determination and Validation of Lung EpiCheck a Multianalyte Assay for Lung Cancer Prediction. A Case-Control Study.
Study Type: Observational
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Nucleix, Inc

Lung Surgery

HUMANITARIAN USE DEVICE: The Spiration® Valve System Protocol# H060002
Study Type: Device Study
Tanya Wiese  D.O.
Tanya Wiese D.O.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Spiration, Inc

Lymphoma

Open-label, 2-arm, randomized, controlled Phase III trial of intravenous PI3K inhibitor copanlisib as monotherapy and in combination with rituximab, compared to rituximab monotherapy, in subjects with indolent B-cell non-Hodgkin lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Bayer Healthcare Pharmaceuticals

Lymphoma

Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T Cells
Study Type: Specimen Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Celgene

Lymphoma

An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an anti-CD20 x anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Follicular Lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Regeneron Pharmaceuticals, Inc.

Lymphoma

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Southwest Oncology Group (SWOG)

Lymphoma

A Phase 2/3, Multicenter, Randomized, Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Karyopharm Therapeutics Inc.

Lymphoma

Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study Comparing the Efficacy and Safety of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) Alone Versus in Combination with Acalabrutinib in Subjects ≤65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AstraZeneca

Lymphoma

A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 Plus Rituximab in Patients with Relapsed/Refractory Non–Hodgkin Lymphoma of B-Cell Origin
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Artiva Biotherapeutics, Inc.

Lymphoma

A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults with Refractory B-Cell Malignancies, in Monotherapy and Combination with IL-2
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Adicet Bio, Inc

Lymphoma

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcRIIB), in Combination with Rituximab in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioInvent International AB

Lymphoma

An Open-Label, Phase 1/2 Study Evaluating AVM0703 in Patients With Lymphoid Malignancies
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AVM Biotechnology

Lymphoma

A SINGLE-ARM, OPEN-LABEL, PHASE 1/2 STUDY EVALUATING THE SAFETY, EFFICACY, AND CELLULAR KINETICS/PHARMACODYNAMICS OF ALLO--501A, AN ANTI-CD19 ALLOGENEIC CAR T CELL THERAPY IN SUBJECTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (LBCL)
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Allogene Therapeutics, Inc.

Lymphoma

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Incyte Corporation

Lymphoma

Long-term Follow-up Protocol for Subjects Treated with Adicet Allogeneic Gamma Delta (γδ) CAR T Cell Investigational Products
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Adicet Therapeutics Inc

Lymphoma

A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: ADC Therapeutics SA

Major Adverse Cardiovascular Events (MACE)

SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity
Study Type: Drug Study
Joseph Lash  M.D.
Joseph Lash M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Novo Nordisk, Inc.

Melanoma

The Sunbelt Melanoma Trial: A Multicenter Trial of Adjuvant Interferon Alfa-2b for Melanoma Patients with Early Lymph Node Metastasis Detected by Lymphatic Mapping and Sentinel Lymph Node Biopsy
Study Type: Specimen Study
Kelly McMasters M.D.
Kelly McMasters M.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: UofL Investigator

Melanoma

A Randomized Phase II, Open-label, Active-controlled, Multicenter Study Investigating the Efficacy and Safety of UV1 Vaccination in Combination with Nivolumab and Ipilimumab as First-line Treatment of Patients with Unresectable or Metastatic Melanoma (UV1-202)
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Ultimovacs

Melanoma

Phase 2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in Patients With Advanced Melanoma Who Have Previously Received anti-PD-[L]1 Therapy - ARTISTRY-6
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Alkermes, Inc

Melanoma

Open-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma (DERM 20-91)
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioNTech RNA Pharmaceuticals GmbH

Merkel Cell Carcinoma

A Phase 2, Open-Label, Single-Arm Study of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Kartos Therapeutics, Inc

Metastatic Colorectal Cancer

A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PDL1 positive Colorectal Cancer
Study Type: Drug Study
Michael Driscoll  M.D.
Michael Driscoll M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck & Co., Inc

Metastatic Esophageal Carcinoma

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal Carcinoma
Study Type: Drug Study
Michael Driscoll  M.D.
Michael Driscoll M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck Sharp & Dohme CORP

Metastatic HER2+ Cancer

A randomized, double-blind, phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for metastatic HER2+ breast cancer (HER2CLIMB-05)
Study Type: Drug Study
Laila Agrawal  M.D.
Laila Agrawal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Seagen Inc.

Multiple Myeloma

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Regeneron Pharmaceuticals, Inc.

Multiple Myeloma

A Phase 1b, Open-Label Study of Eftozanermin Alfa (ABBV-621) in Combination with Bortezomib and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AbbVie

Multiple Myeloma

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Janssen Research & Development

Multiple Myeloma

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Janssen Research & Development

Multiple Myeloma

A Phase 1b, Dose Escalation and Expansion Study of Lemzoparlimab (TJ011133) with or without Dexamethasone and in Combination with Anti-Myeloma Regimens for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AbbVie

Multiple Myeloma

A PHASE I OPEN-LABEL STUDY OF THE SAFETY, TOLERABILITY AND PRELIMINARY CLINICAL ACTIVITY OF ALLOGENEIC INVARIANT NATURAL KILLER (INKT) NON-TRANSDUCED CELLS (AGENT-797) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Agentus Therapeutics

Multiple Sclerosis (MS)

TRaditional versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) Trial
Study Type: Observational
Geeta Ganesh  M.D.
Geeta Ganesh M.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: Johns Hopkins School of Medicine

Myeloid Leukemia

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Seattle Genetics, Inc

Myeloproliferative Neoplasm

A Phase 1 Open-Label Study Evaluating the Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination with Ruxolitinib in Myeloproliferative Neoplasm Subjects
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: AbbVie

Newly Diagnosed Glioblastoma

Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)
Study Type: Drug Study
Renato LaRocca  M.D.
Renato LaRocca M.D.
Principal Investigator
Norton Brain Tumor Center
Sponsor: MimiVax, LLC

NMOSD

CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study Type: Registry
Geeta Ganesh  M.D.
Geeta Ganesh M.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: CorEvitas, LLC

Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination with AB122, and AB154 in Combination with AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
Study Type: Drug Study
Adam Lye  M.D.
Adam Lye M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Arcus Biosciences, Inc.

Non-Small Cell Lung Cancer (NSCLC)

A PHASE 2 STUDY OF BA3011 ALONE AND IN COMBINATION WITH NIVOLUMAB IN ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAD PRIOR DISEASE PROGRESSION ON A PD-1/L-1 INHIBITOR
Study Type: Drug Study
Adam Lye  M.D.
Adam Lye M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: BioAtla LLC

Obstructive Sleep Apnea (OSA)

Investigational Plan for Pivotal THN Study #3 (aura6000 Targeted Hypoglossal Neurostimulation System)
Study Type: Device Study
David Winslow M.D.
David Winslow, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: LivaNova, USA, Inc

Obstructive Sleep Apnea (OSA)

Sleep SMART: Sleep for Stroke Management And Recovery Trial
Study Type: Device Study
David Hasselbacher, M.D.
David Hasselbacher, M.D.
Principal Investigator
Norton Sleep Center
Sponsor: The Regents of the University of Michigan

Oral Appliance

Randomized, Open Label Clinical Trial of an Oral Appliance to Reduce Snoring
Study Type: Device Study
David Winslow M.D.
David Winslow, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Delta Dental

Oropharyngeal Cancer

NRG-HN005: A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients with Early-Stage, p16-Positive, Non-Smoking Associated Oropharyngeal Cancer
Study Type: Drug Study
Aaron Spalding  M.D.
Aaron Spalding M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: NRG Oncology

Ovarian Cancer

MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression
Study Type: Drug Study
Mary Gordinier  M.D.
Mary Gordinier M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: ImmunoGen, Inc.

PAH

RiOciguAt UseRs Registry – The ROAR registry
Study Type: Registry
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Bayer Healthcare Pharmaceuticals

Pancreatic Adenocarcinoma

Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Study Type: Drug Study
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: Bristol-Myers Squibb (BMS)

Pancreatic Adenocarcinoma

Registry To Evaluate Effectiveness And Safety Of The NanoKnife System For The Ablation Of Stage 3 Pancreatic Adenocarcinoma: The Direct Registry For IRE Cancer Treatment
Study Type: Registry
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: AngioDynamics, Inc.

Pancreatic Cancer

Chemotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma
Study Type: Observational
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: UofL Investigator

Pancreatic Cancer

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma
Study Type: Device Study
Robert Martin  M.D., Ph.D.
Robert Martin M.D., Ph.D.
Principal Investigator
University of Louisville Physicians - Surgical Oncology
Sponsor: AngioDynamics, Inc.

Preeclampsia

Antithrombin III (AT) Activity in Women with Severe Preeclampsia (PE) or Superimposed PE prior to 31 weeks
Study Type: Specimen Study
Helen How M.D.
Helen How, M.D.
Principal Investigator
Maternal Fetal Medicine
Sponsor: University of Texas Health Science Center at Houst

Primary Central Nervous System Lymphoma

An open-label phase II study to investigate the efficacy, safety, and pharmacokinetics of tirabrutinib in patients with Primary Central Nervous System Lymphoma (PCNSL)
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: ONO Pharmaceutical Co., Ltd.

Prostate Cancer

A Phase 3 Randomized, Double-Blind Study of Nivolumab or Placebo in Combination with Docetaxel, in Men with Metastatic Castration-resistant Prostate Cancer (CheckMate 7DX:CHECKpoint pathway and nivoluMAB clinical Trial Evaluation 7DX)
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Bristol-Myers Squibb (BMS)

Prostate Cancer

A Phase 1, Dose Escalation Study of JNJ-75229414, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against KLK2 for Metastatic Castration-Resistant Prostate Cancer
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Janssen Research & Development

Prostate Cancer

Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)
Study Type: Drug Study
Joseph Maly  M.D.
Joseph Maly M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck Sharp & Dohme CORP

Prostate Cancer

An Open Label, Single arm, Roll-over Study to provide continued treatment with Darolutamide in participants who were enrolled in previous Bayer-sponsored studies
Study Type: Drug Study
Chandler Park  M.D.
Chandler Park M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Bayer Healthcare Pharmaceuticals

Pulmonary Arterial Hypertension

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-Label Extension (ADVANCE-extension)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: UNITED THERAPEUTICS CORPORATION

Pulmonary Arterial Hypertension

Pulmonary Hypertension Association Registry (PHAR)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Pulmonary Hypertension Association (PHA)

Pulmonary Arterial Hypertension

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Merck Sharp & Dohme CORP

Pulmonary Arterial Hypertension

Retrospective Evaluation of Pulmonary Arterial Hypertension (PAH) Patients: Real-World Experience from the Trio Health Network
Study Type: Registry
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Actelion Pharmaceuticals US, Inc

Pulmonary Arterial Hypertension

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Gossamer Bio, Inc.

Pulmonary Arterial Hypertension

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Rodatristat Ethyl in Patients with Pulmonary Arterial Hypertension
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Altavant Sciences, Inc.

Pulmonary Arterial Hypertension (PAH)

A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: UNITED THERAPEUTICS CORPORATION

Pulmonary Arterial Hypertension (PAH)

A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Actelion/Janssen

Pulmonary Embolism

FLowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Study Type: Registry
Daniel Rothschild M.D.
Daniel Rothschild M.D.
Principal Investigator
Norton Heart & Vascular Institute
Sponsor: Inari Medical Inc

Pulmonary Hypertension

A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: UNITED THERAPEUTICS CORPORATION

Pulmonary Hypertension

An Open-Label Extension study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: UNITED THERAPEUTICS CORPORATION

Pulmonary Hypertension

A Randomized, Double-Blind, Placebo-Controlled Dose Escalation And Verification Clinical Study To Assess The Safety And Efficacy Of Pulsed, Inhaled Nitric Oxide (iNO) In Subjects At Risk Of Pulmonary Hypertension Associated With Pulmonary Fibrosis On Long Term Oxygen Therapy (Part 1 And Part 2)
Study Type: Drug Study
John McConnell M.D.
John McConnell, M.D.
Principal Investigator
Norton Pulmonary Specialists
Sponsor: Bellerophon Pulse Technologies LLC

Recurrent Glioblastoma

A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined with Temozolomide in Patients with Recurrent Glioblastoma
Study Type: Drug Study
Kaylyn Sinicrope, M.D.
Kaylyn Sinicrope, M.D.
Principal Investigator
Norton Brain Tumor Center
Sponsor: Oblato, Inc.

Registry

AANS and ASTRO Stereotactic Radiosurgery Registry (SRS Registry)
Study Type: Registry
Aaron Spalding  M.D.
Aaron Spalding M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: NeuroPoint Alliance

Registry

Laser Ablation of Abnormal Neurological Tissue using Robotic Neuroblate system (LAANTERN) Prospective Registry
Study Type: Registry
David Sun  M.D.
David Sun M.D.
Principal Investigator
Norton Brain Tumor Center
Sponsor: Monteris Medical Corporation

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-413 in Adult Patients with Relapsed or Refractory B-cell Non Hodgkin Lymphoma
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Kymera Therapeutics, Inc

Relapsed or Refractory Diffuse Large B-Cell Lympho

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Merck & Co., Inc

Relapsed or Refractory Lymphomas

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-333 in Adult Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia and Solid Tumors
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Kymera Therapeutics, Inc

Relapsed, Indolent B-Cell Malignancies

A Phase 1a/1b Study of PSB202 in Patients with Previously Treated, Relapsed, Indolent B-Cell Malignancies
Study Type: Drug Study
Don Stevens  M.D.
Don Stevens M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Qilu Puget Sound Biotherapeutics

Relapsed/Refractory Solid Cancers

AN OPEN-LABEL, MULTICENTER, PHASE I STUDY OF IGM-8444 AS A SINGLE AGENT AND IN COMBINATION IN SUBJECTS WITH RELAPSED AND/OR REFRACTORY SOLID CANCERS
Study Type: Drug Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: IGM Biosciences

Relapsed/Refractory Solid tumors

A Phase 1 Open-Label Study Of The Safety, Tolerability And Preliminary Clinical Activity Of Allogeneic Invariant Natural Killer (INKT) Non-Transduced Cells (AGENT-797) As A Single Agent And In Combination With Approved Immune Checkpoint Inhibitors In Patients With Relapsed/Refractory Solid Tumors
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Agentus Therapeutics

Relapsing Multiple Sclerosis (RMS)

A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing Oral SAR442168 to Oral Teriflunomide (Aubagio®) in Patients With Relapsing Forms of Multiple Sclerosis
Study Type: Drug Study
Geeta Ganesh  M.D.
Geeta Ganesh M.D.
Principal Investigator
Norton Neuroscience Institute
Sponsor: Sanofi-Aventis

Rheumatoid Arthritis (RA)

SR™ MCP Implant System ~ Metacarpophalangeal Finger Joint Prosthesis
Study Type: Device Study
Ethan Blackburn M.D.
Ethan BlackburnM.D.
Principal Investigator
Norton Louisville Arm & Hand
Sponsor: Stryker

Robotic Assisted Spine Surgery

Multi-Center Robotic Assisted Spine Surgery
Study Type: Registry
Jeffrey Gum  M.D.
Jeffrey Gum M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: National Spine Health Foundation

Scoliosis

Scoliosis-Specific Exercises for At-Risk Mild AIS Curves: A Multi-Site Preliminary Randomized Trial
Study Type: Observational
Steven Glassman  M.D.
Steven Glassman M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: Texas Scottish Rite Hosp - Scoliosis Research Soci

Scoliosis

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis (Long-term Follow-Up)
Study Type: Observational
Steven Glassman  M.D.
Steven Glassman M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: Scoliosis Research Society (SRS)

Scoliosis

Quantitative Romberg Test in Normal Healthy Volunteers and Patients with Spinal Deformity
Study Type: Observational
Leah Carreon, M.D.
Principal Investigator
Norton Leatherman Spine
Sponsor: NH Investigator

Small Cell Lung Cancer

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study Of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: NRG Oncology

Solid Tumors

PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
Study Type: Drug Study
John Hamm  M.D.
John Hamm M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Pfizer

Specimen

Collection And Distribution Of Biofluids And Tumor Tissue Biospecimens For Research Purposes
Study Type: Specimen Study
Jaspreet Grewal  M.D.
Jaspreet Grewal M.D.
Principal Investigator
Norton Cancer Institute
Sponsor: Bluestar Genomics
Clinical trials

Clinical Trials

Learn more about clinical trials at Norton Healthcare
(502) 629-3500

Is it a monkeypox rash or something minor?

Monkeypox rash symptoms include pimples or blisters that can be painful or itchy and often are located on or near the genitals or anus, according to health care providers. In addition to the groin area, […]

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How to help a loved one cope with dementia-related decision-making changes

Dementia and other neurological disorders can have devasting effects on the patient and their family. One of the ways dementia changes someone’s life is its impact on decision-making: the ability to gather and process information [...]

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From stage 4 prostate cancer to ‘no disease detected’

During the 2018 Bike to Beat Cancer, William Cohen and his Omega Psi Phi fraternity brother pedaled through the “Mile of Silence” – a stretch of the route where riders can reflect on the cause […]

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Deep brain stimulation surgery helps Parkinson’s patient get her life back

Holly Cooper was diagnosed with Parkinson’s disease in 2015. One day, Holly, who also is a breast cancer survivor, noticed a small tremor in her thumb. Over time, the tremor gradually became more debilitating. Daily […]

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What type of arthritis do I have?

Arthritis is a disease of the joints. The two most common types of arthritis are osteoarthritis (OA) and rheumatoid arthritis (RA). If you wonder “What kind of arthritis do I have?” Or if you are […]

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