A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Date Added
February 21st, 2025
PRO Number
Pro00141448
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have recurrent/persistent endometrial cancer. The investigational drug used in this study is Sacituzumab Govitecan (SG). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The study drug is given to participants through infusion. The primary purpose of the study is to compare the effect of SG relative to treatment of physician's choice (TPC) on progression-free survival (PFS) and on overall survival (OS). Participants can expect to be on this study until their demise.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Date Added
February 14th, 2025
PRO Number
Pro00141956
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer who have received at least 1 and no more than 3 prior systemic lines of anticancer therapy. The investigational drug used in this study is Raludotatug Deruxtecan (R-DXd). Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the optimal dose of R-DXd for further clinical development. In Phase 3, participants will be randomized between R-DXd and investigator's choice of chemotherapy. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants through infusion. Participants can continue to receive the study drug until it no longer gives them benefit. Researchers will continue to follow up with patients long-term.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa.

Date Added
February 13th, 2025
PRO Number
Pro00141590
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-304 is a Phase 3, open-label, single-arm design that assesses the safety and tolerability of sonelokimab in adolescent patients with HS. The study population will comprise adolescent participants (aged ≥12 to ≤17 years) with moderate to severe HS.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 12th, 2025
PRO Number
Pro00142401
Researcher
Lauren Sullivan

List of Studies

Keywords
Nontuberculous mycobacteria (NTM)
Summary

This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

Implementation of the New Pediatric Obesity Clinical Practice Guideline in Rural Families and Clinics: A Randomized Clinical Trial

Date Added
February 12th, 2025
PRO Number
Pro00140879
Researcher
James Roberts

List of Studies


Keywords
Children's Health, Obesity, Pediatrics
Summary

iAmHealthy CPG aims to provide valuable insights into tailored obesity interventions for rural populations through dual interventions: iAmHealthy, a family-based behavioral group program delivered via telehealth, and Healthy Clinic, which enhances clinic processes through provider prompts and skills training. The study employs a stepped wedge design, allowing clinics to transition from a control condition to the intervention in staggered, randomized waves.

The study will evaluate the effectiveness of iAmHealthy compared to a control group, assess the impact of the Healthy Clinic intervention on obesity management at the practice-level, and explore the combined effects of both interventions. Quality improvement concepts and processes will be covered through various topics during monthly virtual learning collaborative meetings once your practice enters the intervention phase. Key outcomes will include changes in children's BMI, physical activity, dietary behaviors, and sleep quality.

Institution
MUSC Health Marion Medical Center
Recruitment Contact
Shannon Cabaniss
843-732-1839
smw207@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Date Added
February 12th, 2025
PRO Number
Pro00137540
Researcher
Anand Achanti

List of Studies


Keywords
Kidney
Summary

IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.

The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.

If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.

There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II

Date Added
February 11th, 2025
PRO Number
Pro00141326
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular
Summary

This study is asking for volunteers who have been diagnosed with acute pulmonary embolism (PE). PE is a blood clot that blocks and stops blood flow to an artery in the lung. PE usually results from a blood clot in the leg that travels to the lung. Patients with PE may have shortness of breath, chest pain and/or an irregular heartbeat. This study will use a device known as the Vertex Pulmonary Embolectomy System. The Vertex Pulmonary Embolectomy System is a medical device which is indicated for use in the pulmonary arteries for the non-surgical removal of blood clots from blood vessels. The Vertex System has not yet been approved for use by the Food and Drug Administration (FDA) but is approved for use in this study for PE removal. Your study doctor will inform you about the risks that are related to your PE procedure. The risks associated with the study include loss of confidentiality and unknown risks. There will be no benefit to you, but it is hoped the information gained will add to the understanding of treatment options for others in the future. You do not have to participate to have your condition treated. This study will take 30 days to complete.

Institution
MUSC
Recruitment Contact
Kara Loutzenhiser
843-792-1238
loutzenh@musc.edu

A Multicenter, Open Label, Randomized, Phase 2 Study of Venetoclax and Azacitidine Plus Cusatuzumab Versus Venetoclax and Azacitidine Alone in Newly Diagnosed AML Patients who are not Candidates for Intensive Therapy

Date Added
February 7th, 2025
PRO Number
Pro00139765
Researcher
Alexander Coltoff

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to see if the investigational study drug, called cusatuzumab, is safe and effective when given together with other standard of care drugs used to treat Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow. Cusatuzumab is a new type of drug for AML. Cusatuzumab is designed to target a protein found on the surface of AML tumor cells, called human cluster of differentiation CD70. CD70 is not widely found in healthy cells. By targeting and killing cells expressing CD70, cusatuzumab has been shown in the laboratory and in animal studies to reduce tumor growth. In this study, cusatuzumab is being tested together with two other drugs that are commonly used to treat AML as a standard of care. These standard of care drugs are called venetoclax and azacitidine. In this consent form, cusatuzumab, venetoclax, and azacitidine will be referred to as "study drugs".

Institution
MUSC
Recruitment Contact
Shanta Salzer
8437929300
salzers@musc.edu



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