Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic and debilitating urological
complex of disorders characterized by symptoms of bladder pain or discomfort, mostly upon
bladder filling, and often accompanied by lower urinary tract symptoms (LUTS). This study
will assess how safe and effective BOTOX (onabotulinumtoxinA) is in treating IC/BPS. Adverse
events and change in disease symptoms will be evaluated.
BOTOX (onabotulinumtoxinA) is an investigational drug being developed for the treatment of
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Study doctors randomly assign the
participants to 1 of 2 groups, called treatment arms, to receive BOTOX or placebo. There is a
1 in 2 chance that participants will be assigned to placebo. Approximately 80 female
participants, aged 18 to 75 years, with a diagnosis of IC/BPS will be enrolled in
approximately 40 sites in the United States and Canada.
Participants will receive BOTOX or placebo injected into the bladder on Day 1 and will be
followed for at least 12 weeks in treatment 1. Eligible participants may request additional
dose of BOTOX between Weeks 12 and 24, and will be followed for 12 weeks in treatment period
2.
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 Activity and Adverse Events in Adult Female Participants With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Washington D.C.

Medstar Health Research Institute /ID# 245371

BOTOX

Placebo for BOTOX

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Arm Study to Assess the Safety and Efficacy of a Single Treatment of BOTOX, Followed by an Optional Open-Label Treatment With BOTOX, in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

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

Children's National Medical Center

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 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

Washington DC VA Med Center; Hematology

Obinutuzumab

Prednisone

Placebo

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

MedStar Washington Hospital Center

Carboplatin

Computed Tomography

Ipilimumab

Nab-paclitaxel

Nivolumab

Paclitaxel

Pembrolizumab

Pemetrexed

Quality-of-Life Assessment

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

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

Children's National Hospital

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 study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications

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

Sibley Memorial Hospital

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

This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical
trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian
Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy,
vaccinia-naïve adults 18 to 50 years of age, inclusive. At least 210 participants will be
enrolled and randomized to one of three study arms. The two dose sparing strategies include
one-fifth (2 x 10^7) and one-tenth (1 x 10^7) of the standard dose of MVA-BN administered ID
on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose
standard (1 x 10^8) MVA-BN SC regimen.
The study will enroll a 1:1:1 randomization allocation. Participants will not be stratified
by clinical trial site, demographic characteristics or human immunodeficiency virus (HIV)
infection status; however, these data will be collected during screening and enrollment. Each
participant may be screened either in a separate visit in the 7 days prior to Day 1 or on Day
1.
The primary hypothesis involves a two-step hierarchical process. The study will first test
non-inferiority of the 2 x 10^7 ID regimen relative to 1 x 10^8 SC (standard dose regimen).
If the 2 x 10^7 ID regimen is non-inferior to the standard dose regimen, hypothesis testing
will proceed to test non-inferiority of the 1 x 10^7 ID regimen relative to the standard dose
regimen.
The primary objectives are: 1) to determine if peak humoral immune responses following an ID
regimen of 2 x 10^7 50% Tissue Culture Infectious Dose (TCID50) MVA-BN are non-inferior to
the licensed regimen of 1 x 10^8 MVA-BN administered SC; 2) to determine if peak humoral
immune responses following an ID regimen of 1 x 10^7 TCID50 MVA-BN are non-inferior to the
licensed regimen of 1 x 10^8 MVA-BN administered SC.

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine

The GW Vaccine Research Unit

JYNNEOS

A Phase 2 Randomized, Open-Label, Multisite Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Vaccine

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

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)

District of Columbia