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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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... 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 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... 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 |
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... 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 |
J-Valve TF Early Feasibility Study
JC Medical, Inc.
Aortic Valve Disease
Aortic Valve Insufficiency
Aortic Regurgitation
The main objective of this study is to assess the preliminary safety and effectiveness of the
J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are
judged by a multi-disciplinary heart team to be eligible for the device and to be at high... expand
The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement. 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... 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: Jun 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... 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 |
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... 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 |
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's...
Sutro Biopharma, Inc.
Ovarian Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Platinum-resistant Ovarian Cancer
A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC
chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal
cancers) expressing FOLR1.
expand
A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1. Type: Interventional Start Date: Jul 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.... 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 |
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor...
Hoffmann-La Roche
Small Cell Lung Cancer
Neuroendocrine Carcinoma
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3
parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with
advanced... expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study. Type: Interventional Start Date: Jan 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... 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 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With...
Genentech, Inc.
Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
of RO7303509 treatment in participants with systemic sclerosis (SSc) during a
multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of
study drug will... expand
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo. Type: Interventional Start Date: Jan 2023 |
The GORE® VIAFORT Vascular Stent IVC Study
W.L.Gore & Associates
Venous Thromboses
Venous Disease
Venous Leg Ulcer
Venous Stasis
Venous Ulcer
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the
performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of
symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction
in... expand
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients. Type: Interventional Start Date: Oct 2022 |
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Alliance for Clinical Trials in Oncology
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Ann Arbor Stage I Lymphoma
Ann Arbor Stage II Lymphoma
Ann Arbor Stage III Lymphoma
This study collects blood and tissue samples from patients with cancer and without cancer to
evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue
from patients with and without cancer to study in the laboratory may help researchers develop... expand
This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers. Type: Observational Start Date: Aug 2022 |
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
Georgetown University
Cancer Related Cognitive Decline
Non-metastatic Breast Cancer
This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from
chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators
hypothesize that there will be no significant interaction with Azeliragon and chemotherapy... expand
This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators hypothesize that there will be no significant interaction with Azeliragon and chemotherapy and that targeting the RAGE pathway will decrease anthracycline related cardiotoxicity and chemotherapy related cognitive decline. Type: Interventional Start Date: Jun 2023 |
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely...
Janssen Research & Development, LLC
Crohn's Disease
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to
guselkumab and golimumab.
expand
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab. Type: Interventional Start Date: Jul 2022 |
Evolut™ EXPAND TAVR II Pivotal Trial
Medtronic Cardiovascular
Aortic Stenosis Symptomatic
Moderate Aortic Valve Stenosis
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR
System to include patients with moderate, symptomatic AS.
expand
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS. Type: Interventional Start Date: Apr 2022 |
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 |
Cone Beam Breast CT for Breast Cancer Screening
Koning Corporation
Breast Cancer
Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population
will be enrolled and consented to participate in the study to create an enriched data set.
These women will be enrolled from annual screening population and diagnostic workup
population.... expand
Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed. Type: Interventional Start Date: Oct 2021 |
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... 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) and progression-free survival (PFS) 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 |
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 |
Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma
Alliance for Clinical Trials in Oncology
Angioimmunoblastic T-cell Lymphoma
Enteropathy-Associated T-Cell Lymphoma
Follicular T-Cell Lymphoma
Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy
consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in
treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer
cells by blocking... expand
This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma. Type: Interventional Start Date: Jul 2021 |
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal...
National Cancer Institute (NCI)
Primary Mediastinal Large B-Cell Lymphoma
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may
help the... expand
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). 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. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL. Type: Interventional Start Date: Oct 2021 |
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in...
Hoffmann-La Roche
Advanced Liver Cancers
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with advanced liver cancers. The study is designed with the flexibility to open new treatment
arms as new treatments become available, close existing treatment arms that demonstrate
minimal... expand
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer. Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol. Type: Interventional Start Date: Nov 2020 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
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