
Search Clinical Trials
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Assessment of Combined CCM and ICD Device in HFrEF
Impulse Dynamics
Heart Failure
Heart Failure With Reduced Ejection Fraction
Implantable Defibrillator User
CCM Therapy
Non-ischemic Cardiomyopathy
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System
(the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF)
and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in... expand
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years. Type: Interventional Start Date: May 2023 |
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human...
Gilead Sciences
Locally Advanced or Unresectable Metastatic Breast Cancer
Stage IV Breast Cancer
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life
spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or
spread when compared to current available standard treatments, such as paclitaxel,
nab-paclitaxel... expand
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS). Type: Interventional Start Date: May 2023 |
Study of M5049 in DM and PM Participants (NEPTUNIA)
EMD Serono Research & Development Institute, Inc.
Dermatomyositis
Polymyositis
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049
in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis
(PM) participants for 24 weeks.
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The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks. Type: Interventional Start Date: Jan 2023 |
A Study of MORAb-202 Versus Investigator's Choice Chemotherapy in Female Participants With Platinum-resistant...
Bristol-Myers Squibb
Neoplasms, Ovarian
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab
ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female
participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube... expand
The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer. Type: Interventional Start Date: Feb 2023 |
A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular...
Ionis Pharmaceuticals, Inc.
Hypertriglyceridemia
Cardiovascular Diseases
Atherosclerosis
The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting
triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and
atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.
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The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia. Type: Interventional Start Date: Nov 2022 |
PRO1184 for Advanced Solid Tumors
ProfoundBio US Co.
Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Endometrial Cancer
Non-small Cell Lung Cancer
This study will test the safety, including side effects, and determine the characteristics of
a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic) or
cannot be removed with surgery... expand
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Part A of the study will find out how much and how frequently PRO1184 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1184 is and if it works to treat solid tumor cancers. Type: Interventional Start Date: Dec 2022 |
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy
Hoffmann-La Roche
Facioscapulohumeral Muscular Dystrophy (FSHD)
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability,
pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to
human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular
dystrophy... expand
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular dystrophy (FSHD). Type: Interventional Start Date: Feb 2023 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
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 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab...
Gilead Sciences
Triple Negative Breast Cancer
PD-L1 Positive
The primary objective of this study is to compare the progression-free survival (PFS) between
sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice
(TPC) and pembrolizumab in participants with previously untreated, locally advanced
inoperable... expand
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Type: Interventional Start Date: Jul 2022 |
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced...
EMD Serono Research & Development Institute, Inc.
Locally Advanced or Metastatic Urothelial Carcinoma
The purpose of this study is to assess the safety and efficacy of avelumab in combination
with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.
expand
The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer. Type: Interventional Start Date: Aug 2022 |
LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
PureTech
Idiopathic Pulmonary Fibrosis
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of
LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
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This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Jul 2022 |
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's...
Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and
safety of giredestrant plus everolimus compared with the physician's choice of endocrine
therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal
growth... expand
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting. Type: Interventional Start Date: Aug 2022 |
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants...
Genentech, Inc.
Non-Hodgkin Lymphoma
This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab
subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of
non-Hodgkin's lymphoma [NHL]).
expand
This study will evaluate the efficacy, safety, and pharmacokinetics of mosunetuzumab subcutaneous (SC) formulation in participants with selected B-cell malignancies (types of non-Hodgkin's lymphoma [NHL]). Type: Interventional Start Date: Feb 2022 |
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide...
NRG Oncology
Glioblastoma
Gliosarcoma
This phase III trial compares the effect of adding lomustine to temozolomide and radiation
therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly
diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and
temozolomide,... expand
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, 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. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma. Type: Interventional Start Date: Nov 2021 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment...
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better
match therapies to an individual patient's cancer aggressiveness. The Decipher risk score
evaluates... expand
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Type: Interventional Start Date: Nov 2021 |
Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis
Celgene
Eosinophilic Esophagitis
This study is an open-label, uncontrolled study design to evaluate the long-term safety and
tolerability of treatment with CC-93538. The study will enroll participants who participated
in the CC-93538-EE-001 or CC-93538-DDI-001 studies.
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This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies. Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative...
Amgen
Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of
clinical remission in participants with moderately to severely active ulcerative colitis
(UC).
Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo... expand
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product. Type: Interventional Start Date: Jan 2022 |
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Janssen Research & Development, LLC
Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to
placebo in participants with generalized myasthenia gravis (gMG).
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The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). Type: Interventional Start Date: Jul 2021 |
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Boehringer Ingelheim
Depressive Disorder, Major
This study is open to adults with depression (major depressive disorder) for whom standard
treatment with antidepressants alone does not work sufficiently. The purpose of the trial is
to find out whether a medicine called BI 1358894 helps to improve symptoms of depression.... expand
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants. Type: Interventional Start Date: Nov 2020 |
Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for...
NovoCure GmbH
Glioblastoma Multiforme
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy
(RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy
and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued
following... expand
To test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy. Type: Interventional Start Date: Dec 2020 |
Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and...
Merck Sharp & Dohme LLC
Squamous Cell Carcinoma of Head and Neck
This study is designed to assess the safety and efficacy of lenvatinib in combination with
pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and
efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck... expand
This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review. Type: Interventional Start Date: Aug 2020 |
A Phase 1/2 Study in Patients With HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma...
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of
HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+
confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.... expand
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After...
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy
uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex
hormones,... expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Defining Clinical Endpoints in Limb Girdle Muscular Dystrophy (LGMD)
Virginia Commonwealth University
Limb Girdle Muscular Dystrophy
Muscular Dystrophies
Limb Girdle Muscular Dystrophy comprise a group of disorders made up of over 30 mutations
which share a common phenotype of progressive weakness of the shoulder and hip girdle
muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the
four... expand
Limb Girdle Muscular Dystrophy comprise a group of disorders made up of over 30 mutations which share a common phenotype of progressive weakness of the shoulder and hip girdle muscles. While the individual genetic mutations are rare, as a cohort, LGMDs are one of the four most common muscular dystrophies. The overall goal of project 1 is to define the key phenotypes as measured by standard clinical outcome assessments (COAs) for limb girdle muscular dystrophies (LGMD) to hasten therapeutic development. Type: Observational Start Date: Jun 2019 |
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