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

Milwaukee

Children's Hospital of Wisconsin

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

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

Madison

University of Wisconsin-Madison

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 study is being done to see if tucatinib works better than placebo when given with other
drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks
the same as tucatinib but has no medicine in it. This study will also test what side effects
happen when participants take this combination of drugs. A side effect is anything a drug
does to the body besides treating your disease.
Participants will have cancer that has spread in the body near where it started (locally
advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).
In this study, all participants will get either tucatinib or placebo. Participants will be
assigned randomly to a group. This is a blinded study, so patients and their doctors will not
know which group a participant is in.
All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat
this type of cancer.

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Medical College of Wisconsin (Milwaukee)

Tucatinib

Trastuzumab

Pertuzumab

Combination product: Trastuzumab + Pertuzumab

Placebo

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)

This phase I/II trial tests the safety, side effects, and best dose of selinexor given in
combination with standard radiation therapy in treating children and young adults with newly
diagnosed diffuse intrinsic pontine glioma (DIPG) or high-grade glioma (HGG) with a genetic
change called H3 K27M mutation. It also tests whether combination of selinexor and standard
radiation therapy works to shrink tumors in this patient population. Glioma is a type of
cancer that occurs in the brain or spine. Glioma is considered high risk (or high-grade) when
it is growing and spreading quickly. The term, risk, refers to the chance of the cancer
coming back after treatment. DIPG is a subtype of HGG that grows in the pons (a part of the
brainstem that controls functions like breathing, swallowing, speaking, and eye movements).
This trial has two parts. The only difference in treatment between the two parts is that some
subjects treated in Part 1 may receive a different dose of selinexor than the subjects
treated in Part 2. In Part 1 (also called the Dose-Finding Phase), investigators want to
determine the dose of selinexor that can be given without causing side effects that are too
severe. This dose is called the maximum tolerated dose (MTD). In Part 2 (also called the
Efficacy Phase), investigators want to find out how effective the MTD of selinexor is against
HGG or DIPG. Selinexor blocks a protein called CRM1, which may help keep cancer cells from
growing and may kill them. It is a type of small molecule inhibitor called selective
inhibitors of nuclear export (SINE). Radiation therapy uses high energy to kill tumor cells
and shrink tumors. The combination of selinexor and radiation therapy may be effective in
treating patients with newly-diagnosed DIPG and H3 K27M-Mutant HGG.

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Biopsy

Radiation Therapy

Selinexor

A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)

The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus
placebo for the treatment of participants with active PsA who are naïve to biologic disease
modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long
term extension period will provide additional long-term safety and efficacy 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 or Had Previously Received TNFα Inhibitor Treatment

Rheumatic Disease Center

Deucravacitinib

Apremilast

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment

This trial studies the side effects of radiation therapy followed by atezolizumab in treating
patients with stage II or III non-small cell lung cancer. Hyperfractionated radiation therapy
delivers smaller doses of radiation therapy over time and may kill more tumor cells and have
fewer side effects. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help
the body's immune system attack the cancer, and may interfere with the ability of tumor cells
to grow and spread. The purpose of this study is to test the safety and effectiveness of
radiation therapy followed by atezolizumab and find out what side effects, if any, it has on
patient's non-small cell lung cancer.

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

Ascension Southeast Wisconsin Hospital - Saint Joseph Campus

Atezolizumab

Hypofractionated Radiation Therapy

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status

This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared
with placebo in patients with International Society of Nephrology/Renal Pathology Society
(ISN/RPS) class III or IV lupus nephritis (LN) when added on to standard-of-care therapy
consisting of mycophenolate mofetil (MMF) and corticosteroids.

A Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis

University of Wisconsin School of Medicine and Public Health

Obinutuzumab

Prednisone

Methylprednisolone

Acetaminophen

Diphenhydramine

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY)

This phase II/III trial compares the addition of radiation therapy to the usual treatment
(immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating
patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes
(advanced) or has spread to other places in the body (metastatic) whose tumor is also
negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a
type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors.
This method uses special equipment to position a patient and precisely deliver radiation to
tumors with fewer doses over a shorter period and may cause less damage to normal tissue than
conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab,
ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may
interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as
carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, work in different ways to stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. The addition of radiation therapy to usual treatment may stop
the cancer from growing and increase the life of patients with advanced non-small cell lung
cancer who are PD-L1 negative.

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative

Waukesha

UW Cancer Center at ProHealth Care

Carboplatin

Computed Tomography

Ipilimumab

Nab-paclitaxel

Nivolumab

Paclitaxel

Pembrolizumab

Pemetrexed

Stereotactic Body Radiation Therapy

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The
purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how
safe they are in adult participants with CLL who were previously treated with VenG. Adverse
events and change in disease activity will be assessed.
Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants
in 1 of 2 groups, called treatment arms, based on when symptoms of CLL came back after
previous treatment with VenG. Approximately 75 adult participants with CLL who have been
treated with VenG will be enrolled in the study in approximately 60 sites worldwide.
Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day
cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone,
for a total treatment of 12 to 24 cycles, depending on the cohort.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital or
clinic. The effect of the treatment will be checked by medical assessments, blood tests,
checking for side effects and completing questionnaires.

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

University of Wisconsin-Madiso /ID# 232612

Venetoclax

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

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)

Medical College of Wisconsin

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

Wisconsin