
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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Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Sparrow Pharmaceuticals
Type 2 Diabetes
Cortisol Excess
CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with
type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence
of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to
either clofutriben or placebo in th1 expand
CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment). Type: Interventional Start Date: Nov 2025 |
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A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Scler1
Novartis Pharmaceuticals
Secondary Progressive Multiple Sclerosis (SPMS)
The purpose of this study is to provide efficacy and safety data for remibrutinib in
patients with secondary progressive multiple sclerosis (SPMS) expand
The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS) Type: Interventional Start Date: Nov 2025 |
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Health Promotion With Targeted Exercise Intervention for Decreasing Fall Risk and Inactivity in Agi1
VA Office of Research and Development
Falls
Sarcopenia
Obesity
Falls are a major health risk for older Veterans, especially those with both obesity and
low muscle mass or strength (sarcopenia), which together increase the chances of falling
and losing independence. Many older Veterans have difficulty staying active and often
lack information about how to safel1 expand
Falls are a major health risk for older Veterans, especially those with both obesity and low muscle mass or strength (sarcopenia), which together increase the chances of falling and losing independence. Many older Veterans have difficulty staying active and often lack information about how to safely exercise. While current guidelines focus mostly on weight loss, losing weight alone can weaken muscles and bones, which may actually raise the risk of falls and injuries. This study is testing the benefits of a virtual group exercise program combined with health education. The goal is to find out if exercise combined with health education is better at lowering fall risk and improving daily activity than health education alone for Veterans with obesity and signs of sarcopenia. Type: Interventional Start Date: Apr 2026 |
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A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Imm1
Pfizer
COVID-19 Infection
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy,
superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in
combination with remdesivir IV compared to remdesivir IV alone for the treatment of
symptomatic COVID-19 in severely immunocompromised1 expand
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19. Type: Interventional Start Date: Jul 2025 |
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A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Ve1
Merck Sharp & Dohme LLC
Endometrial Cancer
Researchers are looking for new ways to treat people with proficient mismatch repair
(pMMR) endometrial cancer (EC) that is advanced or recurrent.
- EC is a type of cancer that starts in the tissues inside the uterus (womb)
- pMMR indicates that certain normal proteins are present in the ca1 expand
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. - EC is a type of cancer that starts in the tissues inside the uterus (womb) - pMMR indicates that certain normal proteins are present in the cancer cells - Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery - Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone. Type: Interventional Start Date: May 2025 |
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Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalu1
Alliance for Clinical Trials in Oncology
Castration-Sensitive Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
This phase III trial compares the effect of adding docetaxel to hormonal therapy and
apalutamide versus hormonal therapy and apalutamide alone in treating patients with
prostate cancer that has spread from where it first started (primary site) to other
places in the body (metastatic). Docetaxel is1 expand
This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone. Type: Interventional Start Date: Dec 2025 |
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A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
argenx
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
The main purpose of this study is to compare empasiprubart and IVIg for treating people
with CIDP. This study consists of a Part A where participants will either receive
empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling
empasiprubart for 24 weeks (6 months). Following Pa1 expand
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months). More information can be found here: https://clinicaltrials.argenx.com/emvigorate Type: Interventional Start Date: Aug 2025 |
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A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubici1
Merck Sharp & Dohme LLC
Lymphoma, Large B-Cell, Diffuse
Researchers are looking for ways to treat germinal center B-cell-like diffuse large
B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells.
GCB is a type of DLBCL that affects young B-cells that are still maturing.
The goal of this study is to learn if more people w1 expand
Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP. Type: Interventional Start Date: Apr 2025 |
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The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Boehringer Ingelheim
Bronchiectasis
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis.
People can participate in this study if they produce sputum and have had flare-ups (also
called exacerbations).
The purpose of this study is to find out whether a medicine called BI 1291583 helps
people with bron1 expand
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Jun 2025 |
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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Takeda
Immune Thrombocytopenic Purpura (ITP)
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly
destroys platelets, which are cells that help stop bleeding. This leads to a low number
of platelets, making it easier to bruise or bleed. The main aim of this study is to learn
whether mezagitamab, when given j1 expand
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study). Type: Interventional Start Date: Feb 2025 |
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A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-li1
Janssen Research & Development, LLC
Colorectal Neoplasms
The purpose of this study is to compare how long the participants are disease-free
(progression-free survival) when treated with amivantamab and chemotherapy with
5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin
(mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folin1 expand
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer. Type: Interventional Start Date: Oct 2024 |
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A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Pre1
Pfizer
Menstrual Migraine
The purpose of this study is to evaluate the efficacy and safety of rimegepant when
administered during the peri-menstrual period (PMP) for intermittent prevention of
migraine in women who experience menstrual migraine attacks. expand
The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks. Type: Interventional Start Date: Mar 2025 |
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Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanc1
OncoC4, Inc.
Advanced Solid Tumor
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and
efficacy of AI-081 in solid tumors. expand
BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors. Type: Interventional Start Date: Mar 2025 |
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A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patien1
Hoffmann-La Roche
Lymphoma
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in
participants in the United States, including under-represented racial and ethnic
populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL). expand
The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Type: Interventional Start Date: Apr 2025 |
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A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Imm1
argenx
Primary Immune Thrombocytopenia (ITP)
The main purpose of this study is to look at the effect (efficacy) and safety of
efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up
to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to
receive either efgartigimod IV or placebo1 expand
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancenext Type: Interventional Start Date: Oct 2024 |
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EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empaglifl1
Boehringer Ingelheim
Kidney Disease, Chronic
This study is open to adults with chronic kidney disease at risk of progression. People
with and without type 2 diabetes can take part in this study. The study is open to people
who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or
angiotensin receptor blockers (ARB). P1 expand
This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart disease. This study has 2 parts. In the first part, participants get empagliflozin or placebo matching BI 690517 for at least 6 weeks. Participants continue taking ACEi or ARB throughout the study if such treatments are indicated. In the second part, participants are divided into 2 groups by chance. One group takes BI 690517 tablets and the other group takes placebo tablets. Placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants take 1 tablet once a day in addition to empagliflozin for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 4 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects. Type: Interventional Start Date: Aug 2024 |
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Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cance1
NRG Oncology
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Digestive System Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Brain
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery
(FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer
that has spread from where it first started to the brain. Radiation therapy uses high
energy x-rays to kill tumor cells and1 expand
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain. Type: Interventional Start Date: Dec 2024 |
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Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment1
National Cancer Institute (NCI)
Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
This phase III trial compares durvalumab to the usual approach (patient observation)
after surgery for the treatment of patients with early-stage non-small cell lung cancer.
Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune
system attack the cancer, and may in1 expand
This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach. Type: Interventional Start Date: Apr 2025 |
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Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
Accelerated Cure Project for Multiple Sclerosis
Multiple Sclerosis
Fatigue
CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple
sclerosis (MS). Although they differ, both of these online programs contain information
about MS and fatigue intended to help people with MS understand and manage their fatigue.
This large-scale, decentralized cli1 expand
CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials. The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial. Type: Interventional Start Date: Dec 2024 |
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Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of refractory focal epilepsy. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: May 2024 |
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Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezoliz1
National Cancer Institute (NCI)
Extensive Stage Lung Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase I/II trial tests the safety, side effects, and best dose of iadademstat when
given together with atezolizumab or durvalumab, and studies the effect of the combination
in treating patients with small cell lung cancer that has spread outside of the lung in
which it began or to other parts1 expand
This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer. Type: Interventional Start Date: Apr 2025 |
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Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High1
NRG Oncology
Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
This phase III trial compares stereotactic body radiation therapy (SBRT), (five
treatments over two weeks using a higher dose per treatment) to usual radiation therapy
(20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer.
SBRT uses special equipment to position a p1 expand
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment. Type: Interventional Start Date: Dec 2023 |
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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
W.L.Gore & Associates
Venous Thromboses
Venous Disease
Venous Leg Ulcer
Venous Stasis
Venous Ulcer
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to
evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent
(formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral
venous obstruction. expand
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction. Type: Interventional Start Date: Mar 2023 |
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A Study of ASP3082 in Adults With Advanced Solid Tumors
Astellas Pharma Inc
Solid Tumor
This is an open-label study. This means that people in this study and clinic staff will
know that people will receive ASP3082. The study aims to check how safe and
well-tolerated ASP3082 is for people with advanced solid tumors that have a specific
mutation called KRAS G12D.
This study will be in1 expand
This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment. Type: Interventional Start Date: Jun 2022 |
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A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants1
Janssen Research & Development, LLC
Advanced or Metastatic Colorectal Cancer
The purpose of this study is to assess the anti-tumor activity of amivantamab as a
monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose
(RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize
the safety of amivantamab when added to s1 expand
The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts) and to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts). Type: Interventional Start Date: Jul 2022 |