This phase II trial studies how well the combination of dabrafenib and trametinib works after
radiation therapy in children and young adults with high grade glioma who have a genetic
change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells
and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells
by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their
growth. Giving dabrafenib with trametinib after radiation therapy may work better than
treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade
glioma.

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Providence

Rhode Island Hospital

Biospecimen Collection

Dabrafenib Mesylate

Lumbar Puncture

Magnetic Resonance Imaging

Radiation Therapy

Trametinib Dimethyl Sulfoxide

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

This study has 2 parts: First part is the main study and second part is the extension study.
During the main study participants will receive 1 of 4 study medicines. If participants
continue in the extension study, they will not receive any study medicine during the
extension. The main study will look at how well CagriSema helps participants with excess body
weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and
semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy"
medicine. Which treatment participants get is decided by chance. They will take one injection
once a week. The study medicine is injected briefly with a thin needle, typically in the
stomach, thighs or upper arms.
Extension study: After the main study, not all participants will continue in the extension
study. The study staff will tell the participant if they will continue or not into the
extension study. In the extension study we will look at what happens to the participant's
body weight and diseases related to excess body weight after the participant stops taking the
study medicine. The main study will last for about 1½ years and the extension study will last
for another 2 years.

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Cumberland

Novo Nordisk Investigational Site

Cagrilintide

Semaglutide

Placebo cagrilintide

Placebo semaglutide

Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

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

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 test the long-term safety of rimegepant in the acute
treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of
age).

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

East Greenwich

Velocity Clinical Research, Providence

Rimegepant / BHV3000

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age.

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in
the acute treatment of moderate or severe migraine in children and adolescents.

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Rimegepant/BHV3000

Matching placebo

Phase 3, Multicenter, Randomized, Double-blind,Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant or the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to <18 Years of Age

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

This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of
BLU-5937 in participants with Refractory Chronic Cough (RCC).

A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

Warwick

AAPRI Clinical Research Institute

BLU-5937

Placebo

A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough

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

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 purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo
in skin of color participants with predominant moderate-to-severe body psoriasis or
predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and
symptoms of psoriasis.

Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

Guselkumab

A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Skin of Color Who Have Moderate-to-Severe Plaque Psoriasis and/or Moderate-to-Severe Scalp Psoriasis

Rhode Island