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

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 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

The main purpose of this study is to measure the effect, safety and how well the body absorbs
lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe
atopic dermatitis (AD).

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Lebrikizumab

Topical corticosteroid

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Upper limb essential tremor (UL ET) is a movement disorder characterized by postural and/or
kinetic tremor. It can cause difficulty with everyday tasks such as writing, pouring, and
eating, and patients also experience associated social embarrassment. This study will assess
how safe and effective BOTOX is in treating UL ET. Adverse events and change in disease
activity will be evaluated.
BOTOX is an investigational drug being developed for the treatment of UL ET. Participants are
randomly assigned to 1 of the 4 groups, called treatment arms. Each group receives different
treatment. There is 1 in 2 chance that participants will be assigned to placebo. Around 174
participants, aged 18 to 80 years with UL ET will be enrolled in approximately 40 sites in
North America.
Participants will receive BOTOX or placebo injections in Cycle 1 and Cycle 2. In Cycle 3,
participants will receive unilateral or bilateral BOTOX injections. Each cycle is 12 weeks.
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 of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

Gamma Therapeutic Center /ID# 232547

BOTOX

Placebo for BOTOX

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor

This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and
non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This
clinical trial is designed to assess the safety and microbiological activity of bacteriophage
product WRAIR_PAM-CF1, directed at Pseudomonas aeruginosa in clinically stable CF individuals
chronically colonized with P. aeruginosa. WRAIR_PAM-CF1 is a 4 component anti-pseudomonal
bacteriophage mixture containing between 4 x 10^7 and 4 x 10^9 Plaque Forming Units (PFU) of
bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In
stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a
single dosage of the IV bacteriophage therapy (4 x 10^7 PFU, 4 x 10^8 PFU, and 4 x 10^9 PFU;
total of 6 sentinel subjects), followed by 30 ± 7 days observation period. If no SAEs
(related to the study product) are identified during the 96 hours after bacteriophage
administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In
Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10^7 PFU, 4 x 10^8
PFU, and 4 x 10^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after
all subjects have completed follow up visit 7 on Day 30 to select the IV bacteriophage dose
with the most favorable safety and microbiological activity profile. During Stage 2b,
subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis
following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects
total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b
bacteriophage dose.

A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

WRAIR_PAM-CF1

A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

This study is open to people with a type of cancer called dedifferentiated liposarcoma.
People with advanced liposarcoma aged 18 or older who are not receiving any other cancer
treatment can participate.
The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in
people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to
treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.
During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks,
participants take BI 907828 as tablets or doxorubicin as an infusion into a vein.
Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin
treatment.
Participants can continue treatment in the study as long as they benefit from it and can
tolerate it.
Doctors regularly check the size of the tumour and check whether it has spread to other parts
of the body. The doctors also regularly check participants' health and take note of any
unwanted effects.

Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Boehringer Ingelheim Investigational Site

BI 907828

Doxorubicin

Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of BI 907828 Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

Milwaukee, Wisconsin

Milwaukee

< 0 mi

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

< 0 mi

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

< 0 mi

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

< 0 mi

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

< 0 mi

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

< 0 mi

Transforaminal Lumbar Interbody Fusion (TLIF)

< 0 mi

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

< 0 mi

Study of BOTOX Injections to Assess Change in Disease Symptoms in Adult Participants With Upper Limb Essential Tremor

< 0 mi

A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa

< 0 mi

Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma