This phase III trial investigates the best dose of vinblastine in combination with
selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib
alone in treating children and young adults with low-grade glioma (a common type of brain
cancer) that has come back after prior treatment (recurrent) or does not respond to therapy
(progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells
grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill
cancer cells. Giving selumetinib in combination with vinblastine may work better than
selumetinib alone in treating recurrent or progressive low-grade glioma.

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

Morgantown

West Virginia University Healthcare

Biospecimen Collection

Magnetic Resonance Imaging

Quality-of-Life Assessment

Questionnaire Administration

Selumetinib Sulfate

Vinblastine Sulfate

A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed
for treatment of psoriatic arthritis (PsA).
This study will evaluate the efficacy of izokibep in subjects with PsA.

Psoriatic Arthritis Study of Izokibep

Beckley

Clinical Research Site

Izokibep

Placebo to izokibep

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

The primary objective of this study is to evaluate the safety and efficacy of pitolisant
compared with placebo in treating excessive daytime sleepiness (EDS) in patients with
idiopathic hypersomnia (IH) age ≥18 years.
Key secondary objectives of this study are to assess the impact of pitolisant on:
-  Overall symptoms of IH
-  Patient impression of overall change in their symptoms of IH
-  Investigator assessment of overall disease severity of IH
Other secondary objectives of this study are to assess the impact of pitolisant in patients
with IH on:
-  Patient impression of overall severity of their EDS
-  Functional status and activities of daily living
-  Sleep-related impairment
-  Sleep inertia
-  Cognitive function

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

West Virginia University - Department of Neurology

Pitolisant Oral Tablet

Placebo oral tablet

A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study.
Clinical and radiological evaluation will be performed preoperatively and postoperatively up
to 24 months; and endpoint success will be determined at 24 months postoperatively.
Overall a maximum of 1017 subjects will be enrolled and treated. The purpose of the study is
to provide safety and effectiveness data of Infuse™ in A Transforaminal Lumbar Interbody
Fusion (TLIF) procedures and to obtain indication expansion for Infuse™ use in one and two
level TLIF procedures.

Transforaminal Lumbar Interbody Fusion (TLIF)

West Virginia University, 1 Medical Center Drive

Infuse™ Bone Graft (Infuse™)

Intervertebral body fusion device and Medtronic posterior Fixation Systems

Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft With an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus
placebo in participants with active psoriatic arthritis who are naïve to biologic
disease-modifying anti-rheumatic drugs. The long term extension period will provide
additional long-term efficacy and safety information.

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Rheumatology & Pulmonary Clinic

Deucravacitinib

Placebo

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

The purpose of the study is to assess the safety and tolerability of UCB0599 and to
demonstrate the superiority of UCB0599 over placebo with regard to clinical symptoms of
disease progression over 12 and 18 months in participants diagnosed with early-stage
Parkinson's Disease.

A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease

Crab Orchard

Pd0053 50402

UCB0599

A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's Disease

This phase I trial is to find out the best dose, possible benefits and/or side effects of
lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in
patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow
primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth.
Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune
system attack the cancer, and may interfere with the ability of cancer cells to grow and
spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer
cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents
to improve response. This study may help increase the understanding of lenalidomide and
nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see
whether the control of CNS lymphoma can be extended by using these study drugs as maintenance
(prolonged therapy) after control is achieved with the initial chemotherapy regimen
(induction).

Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Lenalidomide

Methotrexate

Nivolumab

Rituximab

Phase I Trial of Methotrexate, Rituximab, Lenalidomide, and Nivolumab (Nivo-MR2) Induction Followed by Lenalidomide and Nivolumab Maintenance in Primary CNS Lymphoma

To test the effectiveness and safety of Optune® given concomitantly with radiation therapy
(RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy
and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued
following radiation therapy.

Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM

West Virginia University Cancer Institute

Optune®

EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study
assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally
recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor
therapy.

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Research Site

Dato-DXd

Paclitaxel

Nab-paclitaxel

Carboplatin

Capecitabine

Eribulin mesylate

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

The main purpose of this study is to assess the efficacy and safety of Tirzepatide
(LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

West Virginia University

Tirzepatide

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

West Virginia