Search Clinical Trials
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A Novel Digital Music-based Autonomous Personalized Walking Intervention to Improve Gait and Walkin1
Boston University Charles River Campus
Parkinson's Disease (PD)
The purpose of this research study is to examine the effects of a 3-month personalized
community-based walking program using a digital music-based device designed for
self-directed gait training in people with Parkinson disease (PD). The study uses music
cues delivered through this digital device t1 expand
The purpose of this research study is to examine the effects of a 3-month personalized community-based walking program using a digital music-based device designed for self-directed gait training in people with Parkinson disease (PD). The study uses music cues delivered through this digital device to improve walking outcomes. The investigators want to know if personalized music cueing through the digital device can improve walking quality, walking ability, daily walking amount and intensity, and quality of life, while helping walking feel more automatic and require less mental effort. Participants will take part in this research study for approximately 18 weeks in total. During this time, participants will complete 4 study visits at designated research centers at Boston University, Washington University in St. Louis, or the University of Utah, depending on the site of enrollment. Type: Interventional Start Date: Aug 2026 |
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A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Verastem, Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
G12D Mutated KRAS
This study will assess the safety and efficacy of VS-7375 alone and in combination with
cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer expand
This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer Type: Interventional Start Date: Jun 2026 |
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Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervent1
Supira Medical
Coronary Artery Disease
High Risk Percutaneous Coronary Intervention
Interventional Cardiology
Mechanical Circulatory Support
The objective of this study is to assess the safety and efficacy of the Supira System in
providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
Eligible patients will be randomized to undergo HRPCI with either the Supira System
(investigational device) or the commercia1 expand
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device). Type: Interventional Start Date: May 2026 |
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Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients
Satellos Bioscience, Inc.
Duchenne Muscular Dystrophy
Duchenne
DMD
Neuromuscular Diseases
Muscular Dystrophies
Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial
has two parts. In Part 1, the trial will study two doses of SAT-3247 in a randomized,
double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal
dose, safety, tolerability, and preli1 expand
Phase 2a trial of SAT-3247 in ambulatory DMD patients aged ≥ 7 and < 10 years. The trial has two parts. In Part 1, the trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy. In Part 2, the trial will study two doses of SAT-3247 for an additional 9 months. Type: Interventional Start Date: Dec 2025 |
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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is tha1 expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign. Type: Interventional Start Date: May 2025 |
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Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymo1
University of California, San Francisco
Posterior Fossa Ependymal Tumor
This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in
children and young adults with recurrent or progressive Posterior Fossa Group A (PFA)
ependymoma. expand
This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma. Type: Interventional Start Date: May 2026 |
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Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Scree1
Washington University School of Medicine
Lung Cancer
Cancer of the Lung
Inspired by the ongoing Pink & Pearl Campaign, the breast radiology service of Christian
Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this
campaign in its mammography clinics in order to promote awareness, referral, and
completion of lung cancer screening (LCS1 expand
Inspired by the ongoing Pink & Pearl Campaign, the breast radiology service of Christian Hospital in north St. Louis County will partner with Siteman Cancer Center to pilot this campaign in its mammography clinics in order to promote awareness, referral, and completion of lung cancer screening (LCS) among eligible women. This campaign leverages established infrastructure such as nurse navigation and referral to screening or primary care for further shared decision-making on cancer screening. The purpose of this study is to evaluate the effectiveness of the Pink & Pearl Campaign in improving LCS uptake among LCS-eligible women undergoing mammography at Christian Hospital. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, our specific aims for this proposal are to: a) assess whether the Pink & Pearl Campaign increases referrals and uptake/completion of LCS among LCS-eligible women undergoing screening mammography; b) determine median time-to-screening after referral to LCS; and c) evaluate individual and health system factors influencing LCS uptake and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS. Type: Interventional Start Date: Feb 2026 |
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Impact of an Electronic Health Record Maintenance Alert on PSA Screening Rates in a 10-Hospital Int1
Washington University School of Medicine
Prostate Cancer
Cancer of the Prostate
- The investigators propose a clinical trial to evaluate the impact of annual shared
decision making for PSA screening, supported by system-level enhancements to promote
evidence-based care:
- Defined referral thresholds within the health maintenance reminder, aligned with
clinical risk st1 expand
- The investigators propose a clinical trial to evaluate the impact of annual shared decision making for PSA screening, supported by system-level enhancements to promote evidence-based care: - Defined referral thresholds within the health maintenance reminder, aligned with clinical risk stratification per NCCN guidelines. - Enhanced clinical decision support (CDS) tools to reduce provider variation and ensure guideline-concordant screening and referral practices. - The goal is to reduce late-stage presentation without increasing overdiagnosis-ensuring that prostate cancer screening is both accessible and clinically effective. Type: Interventional Start Date: Aug 2025 |
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A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Mu1
Takeda
Multiple Myeloma
Secondary Immunodeficiency
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10
percentage (%) (IGI, 10%) can help prevent infections in participants with multiple
myeloma receiving B-cell maturation antigen (BCMA) x clu1 expand
Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants with multiple myeloma receiving B-cell maturation antigen (BCMA) x cluster of differentiation 3 (CD3) directed bispecific antibody therapy. Participants will be randomly assigned to one of two groups: 1. Primary infection prevention group: They will receive IGI, 10% for 12 months. 2. Secondary infection prevention group: They will only receive IGI, 10% if they develop a serious infection during the 12 months study period. During the study, participants will visit their study clinic 15 times (for 4-week dosing interval) or 19 times (for 3-week dosing interval) and their total participation duration will be up to 14 months (including screening period approximately 8 weeks). Type: Interventional Start Date: Jan 2026 |
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ANCHOR Study: A Study to Assess the Safety and Efficacy of ABBV-CLS-628 in Adult Participants With1
Calico Life Sciences LLC
Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of
kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of
this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of
ADPKD in adult participants.
ABBV-CL1 expand
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jun 2025 |
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Role of KATP Channel Loss in Type 2 Diabetes
Washington University School of Medicine
Obesity and Type 2 Diabetes
Insulin is a hormone that is made by β-cells in the pancreas and when released into the
bloodstream helps control blood sugar levels. Insulin release is regulated by electrical
activity in the β-cell which is generated by the ATP-sensitive potassium (KATP) channel.
While reduced KATP activity is as1 expand
Insulin is a hormone that is made by β-cells in the pancreas and when released into the bloodstream helps control blood sugar levels. Insulin release is regulated by electrical activity in the β-cell which is generated by the ATP-sensitive potassium (KATP) channel. While reduced KATP activity is associated with increased insulin secretion, animals lacking KATP exhibit reduced secretion. This crossover from hypersecretion to undersecretion with KATP loss mirrors insulin secretion during type 2 diabetes. Intriguingly, evidence from cell and animal models suggest that chronically stimulated β-cells can lose KATP revealing a possible role for KATP loss in the failure of insulin secretion and poor control of blood sugar observed in type 2 diabetes. This study will therefore examine insulin responses following ingestion of a single dose of a sulfonylurea called glipizide that inhibits KATP channels in people with and without type 2 diabetes. The goal is to determine whether KATP channel activity is reduced during type 2 diabetes progression. Type: Interventional Start Date: Mar 2025 |
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A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multip1
Celgene
Multiple Sclerosis Spasticity
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986368 in participants with Multiple Sclerosis Spasticity expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity Type: Interventional Start Date: Jun 2025 |
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Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcin1
Regeneron Pharmaceuticals
Cutaneous Squamous Cell Carcinoma (CSCC)
This study will test a study drug called cemiplimab to see if it can help treat
early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab
works by helping the immune system to kill cancer cells. It binds to a protein called
Programmed cell Death-1 (PD-1) on the surface1 expand
This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: - The side effects cemiplimab might cause - How well cemiplimab works compared to surgery Type: Interventional Start Date: Jan 2025 |
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Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal1
NRG Oncology
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Leptomeninges
Stage IV Lung Cancer AJCC v8
This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field
radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that
has spread from where it first started to the cerebrospinal fluid filled space that
surrounds the brain and spinal cord (lep1 expand
This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer. Type: Interventional Start Date: Mar 2025 |
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Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipie1
National Institute of Allergy and Infectious Diseases (NIAID)
Lung Transplant
The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks
in addition to your usual care and medication, will prevent Chronic Lung Allograft
Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of
rejection or inflammation to the transplanted l1 expand
The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death. Type: Interventional Start Date: Mar 2025 |
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Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer
ECOG-ACRIN Cancer Research Group
Refractory Differentiated Thyroid Gland Carcinoma
This phase III trial compares the effect of cabozantinib versus combination dabrafenib
and trametinib for the treatment of patients with differentiated thyroid cancer that does
not respond to treatment (refractory) and which expresses a BRAF V600E mutation.
Cabozantinib is in a class of medications1 expand
This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer. Type: Interventional Start Date: Aug 2024 |
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Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Canc1
Georgetown University
Non-small Cell Lung Cancer Stage III
The goal of this clinical trial is to learn about neoadjuvant cemiplimab with
histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3
non-small cell lung cancer (NSCLC) with select N3 lymph node involvement or other
high-risk subsets in which there is no consensus o1 expand
The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with select N3 lymph node involvement or other high-risk subsets in which there is no consensus on resectability. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes can undergo surgery to remove the cancer after receiving treatment with chemotherapy + immunotherapy. Participants will receive FDA-approved chemotherapy called platinum-doublet chemotherapy together with an immunotherapy drug targeting the immune marker PD-1 called cemiplimab. Patients will receive a 3 drug combination for 4 total treatments given every 3 weeks before surgery. After surgery, patients will have the option to undergo radiation therapy if it is recommended by their treatment team. After this, they will receive cemiplimab every 3 weeks for one year. Type: Interventional Start Date: Aug 2026 |
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Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular L1
National Cancer Institute (NCI)
Classic Follicular Lymphoma
Follicular Lymphoma With Unusual Cytological Features
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating
patients with follicular lymphoma with a low tumor burden. 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 cancer1 expand
This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. 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. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden. Type: Interventional Start Date: Oct 2024 |
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Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic D1
Washington University School of Medicine
Pancreatic Cancer
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at
5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone
have shown improvement in local control, initial invigoration of immune response, and
relief of symptom burden, SBRT has1 expand
The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival. Type: Interventional Start Date: Jan 2024 |
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Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Oct 2023 |
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Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Com1
Alliance for Clinical Trials in Oncology
Anatomic Stage II Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
This phase III trial compares the effect of continuation of treatment with pembrolizumab
(usual approach) to observation only at preventing cancer from coming back in patients
with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete
response after preoperative chemot1 expand
This phase III trial compares the effect of continuation of treatment with pembrolizumab (usual approach) to observation only at preventing cancer from coming back in patients with early-stage triple-negative breast cancer (TNBC) who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. The usual approach for patients with early-stage TNBC who receive preoperative chemotherapy plus pembrolizumab is to continue to receive pembrolizumab for up to 27 weeks after surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation is as good as receiving pembrolizumab for 27 weeks after surgery in triple-negative breast cancer patients who achieved a pathologic complete response after preoperative treatment with chemotherapy and pembrolizumab. Type: Interventional Start Date: Jun 2023 |
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A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and1
Bristol-Myers Squibb
Obstructive Hypertrophic Cardiomyopathy
This registry evaluates patient characteristics, real-world treatment patterns, and
short- and long-term outcomes in a population of patients in the United States and Europe
with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving
mavacamten, receiving other treatment for ob1 expand
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment. United States Sub-Study: The purpose of this study is to evaluate the safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Europe Sub-Study: The purpose of this study is to evaluate the effectiveness and safety of mavacamten in patients with symptomatic obstructive HCM in the real-world setting. Type: Observational [Patient Registry] Start Date: Aug 2022 |
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FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metas1
Regor Pharmaceuticals Inc.
Breast Cancer
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety,
tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B
administered orally as monotherapy OR in combination with Hormonal Therapy in subjects
with HR+, HER2- locally advanced and unresectable1 expand
This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy. Type: Interventional Start Date: Mar 2022 |
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Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of1
Genelux Corporation
Platinum-resistant Ovarian Cancer
Platinum-refractory Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
High-grade Serous Ovarian Cancer
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the
safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab
compared to the Active Comparator Arm with Physician's Choice of chemotherapy and
bevacizumab in women diagnosed with pla1 expand
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population. Type: Interventional Start Date: Aug 2022 |
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Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HE1
Greenwich LifeSciences, Inc.
Breast Cancer
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center,
Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive
subjects who are at high risk for disease recurrence and have completed both neoadjuvant
and postoperative adjuvant standard of car1 expand
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects. Type: Interventional Start Date: Dec 2022 |