LOTAM: A RANDOMIZED, PHASE III CLINICAL TRIAL OF LOW-DOSE TAMOXIFEN FOR SELECTED PATIENTS WITH MOLECULAR LOW-RISK EARLY-STAGE BREAST CANCER

Date Added
May 1st, 2025
PRO Number
Pro00144117
Researcher
Abirami Sivapiragasam

List of Studies

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

This study is for subjects that are post-menopausal women that have been diagnosed with early-stage, low molecular risk breast cancer. Subjects are expected to remain in the study for 60months. There will be a total of 25 subjects enrolled locally.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc0clinical-trials@musc.edu

Perioperative Versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer- Prospect Lung

Date Added
April 30th, 2025
PRO Number
Pro00143693
Researcher
Barry Gibney

List of Studies


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

This is a Phase III study is for patients that have been diagnosed with with early-stage non-small cell lung cancer. The primary purpose of this study is to see if there is a difference in overall survival rate in patients changes based on when they start their drug treatment, either before or after surgical intervention. Participants in this study can expect to be followed for up to 10 years. This study has two groups and a computer will be used to assign study groups. Participants will be randomly assigned to receive either neoadjuvant therapy followed by surgery and adjuvant therapy, or surgery followed by adjuvant therapy. This is called randomization. Patients will have an equal chance of being in either group, similar to flipping a coin.

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

A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide

Date Added
April 30th, 2025
PRO Number
Pro00141089
Researcher
Kimberly Green

List of Studies

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

This is a randomized, Phase 3, active-controlled, parallel, multicenter, interventional, open-label study in participants with relapsed or refractory multiple myeloma who have received 1 to 4 prior lines of therapyincluding an anti-CD38 mAb and lenalidomide.An IRC will be commissioned to adjudicate participants' response to treatment and disease progression.An IDMC will be commissioned to review safety periodically and efficacy at prespecified interim analysis
timepoints.The study will include a Screening Phase, a Treatment Phase, and a Follow-up Phase. The Screening Phase will be up to 28 days before randomization. The Treatment Phase will extend from C1D1 until confirmed disease progression, death, intolerable toxicity, withdrawal of consent, or discontinuation of all study treatment (whichever occurs first). Participants can continue therapy with talquetamab/teclistamab (as appropriate) for up to 26cycles if they have no sign of PD or toxicity. Following the Treatment Phase, participants will continue in the Follow-up Phase until death, withdrawal of consent, loss to
follow-up, orend of the study, whichever occurs first. The EOS is considered as completion of the final OS analysis, which will occur after approximately 311 death events for each comparison.

Institution
MUSC
Recruitment Contact
Shanta Salzer
(843)792-9300
salzers@musc.edu

Lung Cancer Screening, Lung Nodule, and Lung Cancer Biorepository

Date Added
April 24th, 2025
PRO Number
Pro00143404
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Lung
Summary

This study will enroll patients and collect blood samples from those who are either in lung cancer screening, have a lung nodule that is suspicious for malignancy, a newly diagnosed cancer, or healthy control subjects. These samples that are being collected and banked will be used for future development of blood tests to detect lung cancer in future patients at the earliest stages.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Date Added
April 24th, 2025
PRO Number
Pro00137101
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a multicenter, open-label extension (OLE) study to see how safe and effective an inhaled medication called seralutinib is for people with Pulmonary Arterial Hypertension (PAH). The primary objective of this study was to assess improvement in cardiopulmonary hemodynamics as measured by change in pulmonary vascular resistance (PVR) from baseline to Week 24. The secondary objective of this study was to assess improvement in exercise capacity as measured by change in six-minute walk distance (6MWD) from baseline to Week 24.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared with Placebo in Participants with Alcohol Use Disorder

Date Added
April 23rd, 2025
PRO Number
Pro00142519
Researcher
Sarah Book

List of Studies


Keywords
Substance Use
Summary

This is a 28-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, Mazdutide, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to Mazdutide or a matched placebo

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" with the Lung: A Randomized Control Trial (KOURAGE)

Date Added
April 22nd, 2025
PRO Number
Pro00143675
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

This study is designed to help doctors understand how to safely - and at what dose – to give the study drug to patients suffering from acute kidney injury with accompanying acute hypoxic respiratory failure (AHRF). The study is testing Auxora (study drug) against placebo (a substance that has no medical effect).

Your chance of receiving a dose is 50% (for every 1 who receives placebo, 1 receives a dose of Auxora). This selection process is called randomization (like a ‘flip of a coin') and neither you nor your study doctor will know to which group you have been assigned. Every patient in the study will receive his/her dose of Auxora or placebo once a day, for 5 days in a row.

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects with Obesity or Overweight

Date Added
April 17th, 2025
PRO Number
Pro00142892
Researcher
Robert Malcolm

List of Studies


Keywords
Alcohol, Obesity, Weight Control
Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437924442
woodsonm@musc.edu



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