Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
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Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sanofi
Multiple Sclerosis
The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People... expand
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: - This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized. - The study intervention duration will vary ranging from approximately 12 to 40 months. - The assessment of scheduled visits will include 1 common end of study [EOS] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months. Type: Interventional Start Date: Dec 2023 |
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People...
Pfizer
Advanced or Metastatic Breast Cancer
The purpose of this study is to learn about the safety and how effective the study
medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of
treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one
that is unlikely to be cured or taken care... expand
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer. Advanced cancer is the one that is unlikely to be cured or taken care of with treatment. Metastatic cancer is the one that has spread to other parts of the body. This study is seeking female and male participants who: - are 18 years of age or older; - are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; - have advanced or metastatic breast cancer after taking other treatments before this study; - have not taken or need to take medications that are not allowed by the study protocol; - do not have any medical or mental conditions that may increase the risk of study participation. Half of the participants will take PF-07220060 two times daily by mouth along with fulvestrant. Fulvestrant will be given as a shot into the muscle. The other half will take the study doctor's choice of treatment which can either be: - Fulvestrant alone taken as shot into the muscle. - Everolimus along with exemestane taken once daily by mouth. This study will compare the experiences of participants receiving the study medicine plus fulvestrant to those who are receiving the study doctor's choice of treatment. This will help decide if the study medicine is safe and effective. Participants will receive study treatment and/or will be in the study until: - imaging scans (such as an MRI and/or CT) show that their cancer is getting worse. - the study doctor thinks the participant is no longer benefitting from the study medicine. - has side effects that become too severe. A side effect is a reaction (expected or unexpected) to a medicine or treatment you take. - the participant chooses to stop taking part. Type: Interventional Start Date: Jan 2024 |
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Michael B. Atkins, MD
Advanced Renal Cell Carcinoma
This study is a randomized, open label, multicenter Phase II trial to evaluate the
efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and
balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve
patients with metastatic ccRCC. The study... expand
This study is a randomized, open label, multicenter Phase II trial to evaluate the efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve patients with metastatic ccRCC. The study will plan to enroll 120 eligible patients randomized in a 2:1 fashion to Arm A and Arm B. Patients in all IMDC Risk Groups are included. This study utilizes a Simon's two stage design which is described in the protocol. Patients randomized to Arm A will receive botensilimab in combination with balstilimab. Patients randomized to Arm B will receive ipilimumab in combination with nivolumab. Study treatment on both arms will continue until toxicity, disease progression or a maximum of 96 total weeks (12 weeks induction, 84 weeks maintenance). Type: Interventional Start Date: Sep 2023 |
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
Merck Sharp & Dohme LLC
HIV-1 Infection
This is a randomized, active-controlled, double-blind clinical study designed to evaluate
the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL
[MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1
(HIV-1) infection. It is hypothesized... expand
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL [MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. Type: Interventional Start Date: Mar 2023 |
GENERATION HD2. A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With...
Hoffmann-La Roche
Huntington Disease
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with
placebo in participants with prodromal and early manifest Huntington's Disease expand
This study will evaluate the safety, biomarkers, and efficacy of tominersen compared with placebo in participants with prodromal and early manifest Huntington's Disease Type: Interventional Start Date: Feb 2023 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients...
Gilead Sciences
Triple Negative Breast Cancer
The goal of this study is to find out if the experimental product, sacituzumab
govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective
and safe compared to the treatment of physician's choice (TPC) which includes either
pembrolizumab or pembrolizumab plus capecitabine... expand
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment. Type: Interventional Start Date: Dec 2022 |
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
Pfizer
Pneumonia
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate
vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia
(RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae
that cause pneumonia) included in... expand
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: - are male or female ≥65 years of age. - are hospitalized with physician suspicion of community acquired pneumonia (CAP). - have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review. Type: Observational Start Date: Oct 2022 |
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants...
Merck Sharp & Dohme LLC
Metastatic Esophageal Squamous Cell Carcinoma
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus
lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line
intervention in participants with metastatic esophageal carcinoma.
The primary hypotheses are that pembrolizumab plus lenvatinib... expand
The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma. The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Jul 2021 |
MILD® Percutaneous Image-Guided Lumbar Decompression: a Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against
a control group of similar patients... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Biospecimen Procurement for Head and Neck Disorders
National Cancer Institute (NCI)
Hearing Disorder
Oral Mucosal Disease
Pharyngeal Neoplasm
Head and Neck Neoplasms
Laryngeal Disease
Background:
Researchers want to learn more about head and neck disorders. Understanding these
disorders could help them find better treatments. To do this, they are collecting tissue
samples for research.
Objective:
To create a repository of tissue samples and data to better study conditions... expand
Background: Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research. Objective: To create a repository of tissue samples and data to better study conditions of the head and neck. Eligibility: People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2. Design: Participants will be screened with a questionnaire, medical history, and physical exam. Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used. If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2. Part 2: Participants will have additional samples collected. These could be: - Blood: Blood is drawn through a needle in the arm. - Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek. - Saliva: They rinse their mouth with water and spit into a tube or cup. - Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin. - Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed. Participants samples will be used for future research, including genetic testing. Type: Observational Start Date: May 2018 |
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy...
Biohaven Therapeutics Ltd.
Generalized Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an
additional open-label extension (OLE) phase. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of idiopathic generalized epilepsy with generalized tonic-clonic seizures and includes an additional open-label extension (OLE) phase. Type: Interventional Start Date: Jun 2024 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate...
Eli Lilly and Company
Diabetes Mellitus, Type 2
The purpose of this study is to investigate the efficacy and safety of retatrutide
compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic
control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i).
The study will last about 26 months and... expand
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. Type: Interventional Start Date: Feb 2024 |
A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the...
Ipsen
Spasticity as Sequela of Stroke
This study will monitor patients during the first year following their stroke.
Stroke is a very serious condition where there is a sudden interruption of blood flow in
the brain.
The main aim of the study will be to find out how many of those who experience their
first-ever stroke then go on... expand
This study will monitor patients during the first year following their stroke. Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain. The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication. Spasticity is a common post-stroke condition that causes stiff or ridged muscles. The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity. Type: Observational Start Date: Nov 2023 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in Participants with Progressive Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma
Georgetown University
Borderline Resectable Carcinoma
Biliary Tract Cancer
The goal of this clinical trial is to test feasibility and safety of the combination of
tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment
bridge patients to a curative resection in treatment naïve borderline resectable, or
resectable with high risk for recurrence... expand
The goal of this clinical trial is to test feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge patients to a curative resection in treatment naïve borderline resectable, or resectable with high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question[s] it aims to answer are: - What is the rate of conversion of unresectable tumor to resectable cancer? - What are the side effects of this treatment combination? Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection. If the tumor is unresectable (can't be surgically removed) after 4 cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months. Type: Interventional Start Date: Oct 2024 |
A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With...
Hoffmann-La Roche
Carcinoma, Hepatocellular
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate
neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is
designed with the flexibility to open new treatment arms as new agents become available,
close existing treatment arms that... expand
This is a Phase Ib/II, open-label, multicenter, randomized platform study to evaluate neoadjuvant immunotherapy combinations in participants with resectable HCC. The study is designed with the flexibility to open new treatment arms as new agents become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population. Type: Interventional Start Date: Dec 2023 |
A Study of GEn-1124 in Subjects with Acute Respiratory Distress Syndrome (ARDS)
GEn1E Lifesciences
Respiratory Distress Syndrome, Acute
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of
GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible
after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after
the first dose and will continue with... expand
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days. Type: Interventional Start Date: Apr 2023 |
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Eli Lilly and Company
Breast Neoplasms
The main purpose of this study is to measure how well imlunestrant works compared to
standard hormone therapy in participants with early breast cancer that is estrogen
receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants
must have already taken endocrine therapy for... expand
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Type: Interventional Start Date: Oct 2022 |
A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients
Georgetown University
Ovarian Cancer Stage IV
Ovarian Cancer Stage III
Ovarian Cancer Stage 3
This is an open label, non-randomized, 2-stage phase II, single arm study to determine
the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine
as a priming mechanism to prevent anti-PD1 resistance in patients with
platinum-refractory stage III/IV ovarian cancer (OC). expand
This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC). Type: Interventional Start Date: Oct 2024 |
Testing Atezolizumab With or Without Selinexor in Patients >= 18 Years Old With Alveolar Soft Part Sarcoma,...
National Cancer Institute (NCI)
Advanced Alveolar Soft Part Sarcoma
Advanced Soft Tissue Sarcoma
Metastatic Alveolar Soft Part Sarcoma
Unresectable Alveolar Soft Part Sarcoma
This phase II trial tests whether atezolizumab alone or in combination with selinexor
works to shrink tumors in patients with alveolar soft part sarcoma and whether the study
drugs are better than the usual approach in treating this type of cancer. The usual
approach is defined as care most people... expand
This phase II trial tests whether atezolizumab alone or in combination with selinexor works to shrink tumors in patients with alveolar soft part sarcoma and whether the study drugs are better than the usual approach in treating this type of cancer. The usual approach is defined as care most people get for alveolar soft part sarcoma if they are not part of a clinical study, which includes treatment with radiation, kinase inhibitor drugs, immunotherapy drugs, or chemotherapy drugs. 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. Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may help keep cancer cells from growing and may kill them. Giving atezolizumab alone or in combination with selinexor may help shrink tumors and stabilize the cancer in patients with alveolar soft part sarcoma. Type: Interventional Start Date: Aug 2022 |
Evolut™ EXPAND TAVR II Pivotal Trial
Medtronic Cardiovascular
Moderate Aortic Valve Stenosis
Obtain safety and effectiveness data to support indication expansion for the Medtronic
TAVR System to include patients with moderate, AS. expand
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS. Type: Interventional Start Date: Apr 2022 |
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple...
Novartis Pharmaceuticals
Relapsing Multiple Sclerosis
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with
relapsing multiple sclerosis (RMS) expand
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) Type: Interventional Start Date: Dec 2021 |
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching...
Mirum Pharmaceuticals, Inc.
Primary Biliary Cholangitis
PBC
The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC. expand
The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC. Type: Interventional Start Date: Sep 2021 |
Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive...
Novartis Pharmaceuticals
Atypical Hemolytic Uremic Syndrome
The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is
efficacious and safe for the treatment of aHUS in adult patients who are treatment naive
to complement inhibitor therapy. expand
The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy. Type: Interventional Start Date: Jan 2022 |
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