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Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in...
NYU Langone Health
Melanoma
Unresectable Melanoma
The study will evaluate how safe the study drug is, how well you tolerate it, and how it
works in the body and the disease's response to the drug. The study drug being tested is
sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in
patients with stage III or stage... expand
The study will evaluate how safe the study drug is, how well you tolerate it, and how it works in the body and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for this type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA. Type: Interventional Start Date: Dec 2022 |
TMS as a Treatment for Apathy in Alzheimer's Disease
Massachusetts General Hospital
Alzheimer Disease
Apathy in Dementia
This proposal will demonstrate that non-invasive brain stimulation is able to modulate
cortico-striatal circuits in neurodegenerative patients with apathy, and that doing so
results in circuit-specific increases in FC and DA availability. These circuit changes
will be accompanied by changes in specific... expand
This proposal will demonstrate that non-invasive brain stimulation is able to modulate cortico-striatal circuits in neurodegenerative patients with apathy, and that doing so results in circuit-specific increases in FC and DA availability. These circuit changes will be accompanied by changes in specific behavioral dimensions of apathy. This work will lead to larger studies which develop personalized, circuit-specific neuromodulation strategies for AD patients suffering from this intractable neuropsychiatric symptom. Type: Interventional Start Date: May 2024 |
A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's...
Biogen
Parkinson Disease
In this study, researchers will learn more about a study drug called BIIB122 in
participants with early-stage Parkinson's disease (PD). In this study:
- Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by
mouth. A placebo looks like the study drug but has no... expand
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122. Type: Interventional Start Date: Apr 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period expand
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 2022 |
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD. expand
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Type: Interventional Start Date: Jul 2022 |
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Janssen Research & Development, LLC
Multiple Myeloma
The purpose of this study is to collect long-term follow-up data on delayed adverse
events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize
and understand the long-term safety profile of cilta-cel. expand
The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel. Type: Interventional Start Date: Mar 2022 |
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
DualityBio Inc.
HER2-positive Advanced Solid Tumor
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and
tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2. expand
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2. Type: Interventional Start Date: Jan 2022 |
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
MGH Institute of Health Professions
Language Disorders in Children
In the proposed project, the investigators will conduct a multisite randomized controlled
trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused
comprehension intervention, on children's lower- and higher-level language skills and
comprehension skills in the short-... expand
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3). Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school. Type: Interventional Start Date: Jan 2021 |
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease...
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will determine the recommended dose of
mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by
testing how well mitapivat works compared to placebo to increase the amount of hemoglobin
in the blood and to reduce or prevent... expand
This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion. Type: Interventional Start Date: Feb 2022 |
A Study of AAV9 Gene Therapy in Participants With Canavan Disease (CANaspire Clinical Trial)
Aspa Therapeutics
Canavan Disease
The main objective of this trial is to evaluate the safety, tolerability, and
pharmacodynamic activity of BBP-812, an investigational AAV9-based gene therapy, in
pediatric participants with Canavan disease. expand
The main objective of this trial is to evaluate the safety, tolerability, and pharmacodynamic activity of BBP-812, an investigational AAV9-based gene therapy, in pediatric participants with Canavan disease. Type: Interventional Start Date: Sep 2021 |
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
A2 Biotherapeutics Inc.
Solid Tumor, Adult
Colorectal Cancer
Non Small Cell Lung Cancer
Pancreatic Cancer
CRC
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte
Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an
eligible participant's own T cells for future use to make CAR T-Cell therapy for their
disease treatment.
Design:
This... expand
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer. Type: Observational Start Date: Oct 2021 |
Pancreatic Cancer Early Detection Consortium
Arbor Research Collaborative for Health
Pancreas Cancer
Pancreas Cyst
Pancreatic Ductal Adenocarcinoma
Genetic Predisposition
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct
research on multiple aspects of early detection and prevention of pancreatic ductal
adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family
history of PDAC and/or individuals carrying... expand
The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and/or individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up. Type: Observational Start Date: Sep 2020 |
Study of INBRX-109 in Conventional Chondrosarcoma
Inhibrx Biosciences, Inc
Conventional Chondrosarcoma
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or
metastatic conventional chondrosarcoma patients. expand
Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients. Type: Interventional Start Date: Sep 2021 |
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine...
Merck Sharp & Dohme LLC
Pheochromocytoma/Paraganglioma
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor
HIF-2α Mutated Cancers
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in
participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic
neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced
Gastrointestinal Stromal Tumor (wt GIST), or Advanced... expand
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Aug 2021 |
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout
Massachusetts General Hospital
Gout
The TRUST study is a randomized, controlled multicenter study to evaluate the management
of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to
determine the most beneficial for a patient-centered gout outcomes, as well as relevant
cardiovascular-metabolic-renal endpoints. expand
The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints. Type: Interventional Start Date: Feb 2024 |
SBRT + Atezolizumab + Bevacizumab in Resectable HCC
Massachusetts General Hospital
Hepatocellular Carcinoma
Resectable Hepatocellular Carcinoma
This study is evaluating the safety and tolerability of neoadjuvant stereotactic body
radiation therapy (SBRT) with atezolizumab and bevacizumab for treating resectable
hepatocellular carcinoma.
This study involves the following study interventions:
- Atezolizumab
- Bevacizumab... expand
This study is evaluating the safety and tolerability of neoadjuvant stereotactic body radiation therapy (SBRT) with atezolizumab and bevacizumab for treating resectable hepatocellular carcinoma. This study involves the following study interventions: - Atezolizumab - Bevacizumab - Stereotactic Beam Radiation Therapy (SBRT) - Surgery Type: Interventional Start Date: Jun 2021 |
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Boston Scientific Corporation
Pulmonary Embolism
There are many available treatments for pulmonary embolism (PE), but the best treatment
for this condition is not known. The HI-PEITHO study will compare two treatment options
that are both available on the market for the treatment of PE.
Patients will be randomized 1:1 to receive either blood thinners... expand
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems. Type: Interventional Start Date: Aug 2021 |
Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma...
C4 Therapeutics, Inc.
Multiple Myeloma
Lymphoma, Non-Hodgkin's
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics,
pharmacodynamics, and antitumor activity of oral cemsidomide (also known as CFT7455)
administered at different dosages in subjects with Relapsed/Refractory (r/r)
Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma... expand
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of oral cemsidomide (also known as CFT7455) administered at different dosages in subjects with Relapsed/Refractory (r/r) Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM). Cemsidomide may be administered as a single agent and, in MM only, in combination with oral dexamethasone. Type: Interventional Start Date: Apr 2021 |
Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
United Therapeutics
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against
placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. expand
Study RIN-PF-301 is designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52. Type: Interventional Start Date: Jun 2021 |
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled...
Incyte Corporation
B-Cell Malignancies
This is a Phase 2, multicenter, open-label study to provide continued supply of
parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or
ibrutinib to participants from Incyte-sponsored studies of parsaclisib. expand
This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib. Type: Interventional Start Date: Aug 2020 |
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With...
Takeda
Solid Neoplasms
The main aim of this study is to check if people with advanced solid tumors have side
effects from dazostinag, and to check how much dazostinag they can receive without
getting significant side effects from it when given alone and in combination with
pembrolizumab. The study will be conducted in two... expand
The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC). Type: Interventional Start Date: Jul 2020 |
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
Alliance for Clinical Trials in Oncology
CDK Gene Mutation
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
NTRK Family Gene Mutation
PI3K Gene Mutation
This phase II trial studies how well genetic testing works in guiding treatment for
patients with solid tumors that have spread to the brain. Several genes have been found
to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C.
Medications that target these genes... expand
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. Type: Interventional Start Date: Aug 2019 |
Trial of Parkinson's And Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants... expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL)...
Memorial Sloan Kettering Cancer Center
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Leukemia (SLL)
The purpose of this study is to determine the rate of minimum residual disease (MRD)
negative response (i.e. the rate of no evidence of disease) of the study drugs,
zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL
and/or SLL. expand
The purpose of this study is to determine the rate of minimum residual disease (MRD) negative response (i.e. the rate of no evidence of disease) of the study drugs, zanubrutinib, obinutuzumab, and venetoclax, given in combination as a treatment for CLL and/or SLL. Type: Interventional Start Date: Feb 2019 |
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
National Cancer Institute (NCI)
Autoimmune Disease
Crohn Disease
Dermatomyositis
Hematopoietic and Lymphoid Cell Neoplasm
Inflammatory Bowel Disease
This phase Ib trial studies the side effects of nivolumab and to see how well it works in
treating patients with autoimmune disorders and cancer that has spread to other places in
the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as
nivolumab, may help the body's... expand
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Type: Interventional Start Date: Jul 2019 |
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