
Search Clinical Trials
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A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Acti1
Merck Sharp & Dohme LLC
Colitis Ulcerative
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with
moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690
is superior to placebo with respect to the proportion of participants achieving clinical
remission per Modified Mayo Scor1 expand
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12. Type: Interventional Start Date: Mar 2026 |
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A Study of Buntanetap in Participants With PD
Annovis Bio Inc.
Parkinson's Disease (PD)
Deep Brain Stimulation
This study will examine the long-term safety of buntanetap in participants with PD. This
will be a 36-month open-label safety study. This study will be conducted with two
cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously
participated in buntanetap clinical tr1 expand
This study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days. Type: Interventional Start Date: Jan 2026 |
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A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-01
Merck Sharp & Dohme LLC
Pulmonary Arterial Hypertension
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the
lungs become thick and narrow, which makes it harder for blood to flow. This causes high
blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and
be active. Some standard (usual) tre1 expand
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time. Type: Interventional Start Date: May 2021 |
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A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemother1
Amgen
Metastatic Castration-resistant Prostate Cancer
The primary objective of this study is to compare overall survival (OS) in participants
receiving xaluritamig plus abiraterone against investigator's choice (docetaxel,
cabazitaxel, or abiraterone). expand
The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone). Type: Interventional Start Date: Nov 2025 |
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OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Preve1
Amgen
Cardiovascular Disease
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the
risk for coronary heart disease death (CHD death), myocardial infarction, or urgent
coronary revascularization in participants at risk for a first major cardiovascular event
with elevated lipoprotein(a) (Lp[a]1 expand
The primary objective is to evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]). Type: Interventional Start Date: Aug 2025 |
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A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fian1
NSABP Foundation Inc
Colo-rectal Cancer
The NSABP FC-13 study is being done to determine if using immunotherapies alone or in
combination with other drugs will delay or prevent colorectal cancer from coming back in
patients with colorectal cancer who are ctDNA-positive after their treatment.
Immunotherapeutic drugs (immunotherapies) act1 expand
The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075. Type: Interventional Start Date: Apr 2026 |
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Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Adva1
Relay Therapeutics, Inc.
PIK3CA Mutation
HER2- Negative Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Metastatic Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the
efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the
treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or
progression on or after treatment with a CDK4/61 expand
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor. Type: Interventional Start Date: Aug 2025 |
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A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With R1
BeOne Medicines
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone
compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously
treated with a covalent Bruton tyrosine kinase1 expand
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Type: Interventional Start Date: Sep 2025 |
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A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Dise1
BlueRock Therapeutics
Parkinsons Disease (PD)
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled,
double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102
adults with Parkinson's Disease (PD). expand
Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD). Type: Interventional Start Date: Jun 2025 |
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Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)
Connect Biopharm LLC
COPD Acute Exacerbation
This is a Phase 2, multicenter study in adult participants with an acute COPD
exacerbation and type 2 inflammation expand
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation Type: Interventional Start Date: Aug 2025 |
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A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Boehringer Ingelheim
Interstitial Lung Diseases
Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Adults 18 years of age and older or above legal age with lung fibrosis related to
systemic autoimmune rheumatic disease can participate in this study. People can only take
part if they show no improvement in lung function after standard treatment with
immunosuppressant medicine. The main purpose of1 expand
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Sep 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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Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the1
National Cancer Institute (NCI)
Non-Muscle Invasive Bladder Urothelial Carcinoma
Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage I Bladder Cancer AJCC v8
This phase II trial compares the use of pembrolizumab and radiation therapy to
chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation
therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with
monoclonal antibodies, such as pembrolizumab, may1 expand
This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. 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. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, 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 x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer. Type: Interventional Start Date: Jun 2025 |
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A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
Stemline Therapeutics, Inc.
Advanced Breast Cancer
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor,
in adult participants with advanced breast cancer. expand
This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer. Type: Interventional Start Date: Oct 2024 |
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Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non1
Alliance for Clinical Trials in Oncology
Resectable 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 standard therapy given after surgery (adjuvant) to standard
therapy given before and after surgery (perioperative) in treating patients with stage
II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable).
The usual approach for patients wi1 expand
This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC. Type: Interventional Start Date: Dec 2024 |
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The Fourth Left Atrial Appendage Occlusion Study
Hamilton Health Sciences Corporation
Atrial Fibrillation
Stroke, Ischemic
Systemic Embolism
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion
prevents ischemic stroke or systemic embolism in participants with atrial fibrillation,
who remain at high risk of stroke, despite receiving ongoing treatment with oral
anticoagulation. expand
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation. Type: Interventional Start Date: Nov 2023 |
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Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
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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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Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capeci1
National Cancer Institute (NCI)
Metastatic Colorectal Carcinoma
Metastatic Malignant Solid Neoplasm
Stage IV Colorectal Cancer AJCC v8
Unresectable Colorectal Carcinoma
Unresectable Malignant Solid Neoplasm
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in
combination with the usual treatment with capecitabine in treating patients with cancer
that has spread from where it first started (primary site) to other places in the body
(metastatic) or cannot be removed by surger1 expand
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors. Type: Interventional Start Date: Nov 2023 |
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A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Xenon Pharmaceuticals Inc.
Primary Generalized Tonic-Clonic Seizures
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). expand
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS). Type: Interventional Start Date: Feb 2023 |
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Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and1
SWOG Cancer Research Network
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
This phase II Lung-MAP treatment trial test the combination of targeted drugs
(capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell
lung cancer that may have spread from where it first started to nearby tissue, lymph
nodes, or distant parts of the body (advanced) an1 expand
This phase II Lung-MAP treatment trial test the combination of targeted drugs (capmatinib, osimertinib, and/or ramucirumab) in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has EGFR and MET gene changes. Capmatinib and osimertinib are in a class of medications called kinase inhibitors. They work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving capmatinib, osimertinib, and/or ramucirumab and targeting abnormal gene changes in tumor cells may be effective in shrinking or stabilizing advanced non-small cell lung cancer. Type: Interventional Start Date: May 2023 |
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A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal1
Janssen Research & Development, LLC
Carcinoma, Non-small-Cell Lung
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characteriz1 expand
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Type: Interventional Start Date: Nov 2022 |
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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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A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Can1
Astellas Pharma Global Development, Inc.
Gastric Adenocarcinoma
Gastroesophageal Junction (GEJ) Adenocarcinoma
Pancreatic Adenocarcinoma
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It
is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help
control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune
cell called a T-cell. This "tel1 expand
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: - To check the safety of ASP2138 and how well people can tolerate medical problems during the study. - To find a suitable dose of ASP2138 to be used later in the study. - These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 - ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). - Different small groups are given lower to higher doses of ASAP2138. - ASP2138 is either given by itself, or given with 1 of 3 standard treatments: - Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) - Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) - ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 - ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. - People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. - This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. - The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself. Type: Interventional Start Date: Jun 2022 |