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

Wilmington

Alfred I duPont Hospital for Children

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 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

Dabrafenib Mesylate

Lumbar Puncture

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 phase III trial studies how well atezolizumab added to the usual radiation therapy works
in treating patients with stage I-IIA non-small cell lung cancer. 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. Radiation
therapy, such as stereotactic body radiation therapy, uses special equipment to position a
patient and deliver radiation to tumors with high precision. This method can kill tumor cells
with fewer doses over a shorter period and cause less damage to normal tissue. Giving
atezolizumab and radiation therapy may work better than radiation therapy alone in treating
patients with early non-small cell lung cancer.

Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Rehoboth Beach

Beebe Health Campus

Atezolizumab

Stereotactic Body Radiation Therapy

A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

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)

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed
treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic
lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications
called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by
blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal
antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and
may interfere with the ability of tumor cells to grow and spread. Starting treatment with the
venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes
for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to
starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Bone Marrow Aspiration

Computed Tomography

Obinutuzumab

Venetoclax

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell
responsible for fighting infections). The purpose of this study is to assess the safety and
tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants
with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be
assessed.
Epcoritamab is an investigational drug being developed for the treatment of NHL. Study
doctors put the participants in groups called treatment arms. The combination of epcoritamab
with anti-neoplastic agents will be explored. Each treatment arm receives a different
treatment combination depending on eligibility. Approximately 132 adult participants with NHL
will be enrolled in 100 sites globally.
In both the dose escalation and dose expansion arms participants will receive subcutaneous
(SC) epcoritamab in combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2
and 21- day cycles for arm 3.
Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with
relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in
participants with with R/R DLBCL.
Arm 3: SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab,
IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in
participants with newly diagnosed treatment-naïve DLBCL.
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 an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, questionnaires and side effects.

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Newark

Christiana Care Health Service /ID# 242301

Epcoritamab

Lenalidomide

Ibrutinib

Rituximab

Cyclophosphamide

Doxorubicin Hydrochloride [HCl]

Prednisone

Polatuzumab

Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

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

Carboplatin

Ipilimumab

Nab-paclitaxel

Nivolumab

Paclitaxel

Pembrolizumab

Pemetrexed

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

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

Nemours/AI DuPont Hospital for Children

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

The primary purpose of this trial is to investigate whether men with idiopathic infertility
(unexplained reduction of semen quality), after being treated with a daily dose of 12 µg
recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of
spontaneous pregnancy observed in their female partners in comparison to placebo (inactive
treatment).

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

Ferring Investigational Site

FE 999049

Placebo

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of FE 999049 for Treatment of Men With Idiopathic Infertility

This phase II trial studies whether adding pembrolizumab to olaparib (standard of care) works
better than olaparib alone in treating patients with pancreatic cancer with germline BRCA1 or
BRCA2 mutations that has spread to other places in the body (metastatic). BRCA1 and BRCA2 are
human genes that produce tumor suppressor proteins. These proteins help repair damaged
deoxyribonucleic acid (DNA) and, therefore, play a role in ensuring the stability of each
cell's genetic material. When either of these genes is mutated, or altered, such that its
protein product is not made or does not function correctly, DNA damage may not be repaired
properly. As a result, cells are more likely to develop additional genetic alterations that
can lead to some types of cancer, including pancreatic cancer. Immunotherapy with monoclonal
antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and
may interfere with the ability of tumor cells to grow and spread. Olaparib is an inhibitor of
PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep tumor cells from
repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted
therapy. The addition of pembrolizumab to the usual treatment of olaparib may help to shrink
tumors in patients with metastatic pancreatic cancer with BRCA1 or BRCA2 mutations.

Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations

Olaparib

Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients With Germline BRCA1 or BRCA2 Mutations

Delaware