OASIS Project 1: Development of a text message-based approach to depression screening for cancer survivors

Date Added
May 30th, 2025
PRO Number
Pro00143112
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer
Summary

Depression is common among cancer survivors, but current ways to address this area of care are lacking. In this project, we will work with cancer survivors and oncology providers to build a text-message based approach to screen cancer survivors for depression. Long term, we hope this research can be used to improve screening for depression for cancer survivors

Institution
MUSC
Recruitment Contact
Nivetha Baskar
843-792-0719
baskar@musc.edu

Pilot Evaluation of a 2D Embodied Conversational Agent to Support Speech Engagement in Parkinson's Disease

Date Added
June 4th, 2025
PRO Number
Pro00145307
Researcher
Kelly Richardson

List of Studies

Keywords
Parkinsons
Summary

We are testing a 2D system designed to help people with Parkinson's disease practice their speech. In this study, participants will speak with a virtual character, called an embodied conversational agent, using a laptop. Our goal is to see if this technology is helpful and easy to use for people with Parkinson's disease to use. This research will help us learn whether using virtual characters at home could support long-term speech improvements.

Institution
MUSC
Recruitment Contact
Kelly Richardson
8437929468
richkell@musc.edu

Randomized Phase 2 Trial of Sacituzumab Govitecan With or Without Pembrolizumab in First-line Metastatic PD-L1-negative TNBC

Date Added
July 8th, 2025
PRO Number
Pro00145388
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone in patients with PD-L1-negative metastatic TNBC, who have not received prior therapy for metastatic breast cancer and who have not received a prior PD-1/L1 inhibitor.

Subjects can remain on study for as long as they are benefitting from treatment - there are no set number of visits required to participate in this study. Sacituzumab govitecan and pembrolizumab are taken via intravenous (IV) infusion. Risks include decrease in white blood cell count, anemia, nausea, joint pain, and headache.

The U.S. Food and Drug Administration (FDA) has approved Sacituzumab govitecan for metastatic triple-negative breast cancer, however, it is considered experimental in this study because it is currently only approved for patients who have had more treatment than patients eligible to participate in this study. The FDA has approved Pembrolizumab for metastatic triple-negative breast cancer, but it is also considered experimental in this study because it is not currently approved for patients with PD-L1 negative cancer.

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

Randomized Phase II study of the Addition of Targeted Therapeutic Agents to Tafasitamab-based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-cell Lymphoma

Date Added
July 10th, 2025
PRO Number
Pro00146204
Researcher
Brian Hess

List of Studies


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

This is a randomized, phase II study for patients with Relapsed/Refractory Large B-Cell Lymphoma. The purpose of this study is to determine how long people with Large B-Cell Lymphoma can live without their disease getting worse when treated with two different combinations of cancer drugs. One group will get tafasitamab + lenalidomide + tazemetostat, and the other group will get tafasitamab + lenalidomide + zanubrutinib. The researchers want to see which combination works better. They also want to figure out the best and safest dose of each drug combination to use in future studies. Tafasitamab is a lab-made antibody that helps the immune system find and attack cancer cells. Lenalidomide is a drug that boosts the immune system and helps fight cancer. Tazemetostat is a drug that blocks a protein (EZH2) that helps cancer cells grow. Zanubrutinib is a drug that blocks another protein (BTK) involved in cancer cell survival. The treatment period may last approximately 1 year and the follow up period may last up to 3 years.

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

A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

Date Added
August 7th, 2025
PRO Number
Pro00143120
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this 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
8437929321
hcc-clinical-trials@musc.edu

Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction (ELEVATE-HFpEF)

Date Added
August 12th, 2025
PRO Number
Pro00146339
Researcher
Daniel Silverman

List of Studies

Keywords
Heart
Summary

This study is enrolling participants with heart failure, a condition where the heart muscle does not pump blood efficiently, with preserved ejection fraction, meaning the heart muscle contracts (squeezes) normally but is unable to relax appropriately. The study involves implanting a pacemaker, a small device that is placed in the upper left chest, and then programming it to either standard settings or personalized settings for you based on your height and heart function. The programming is randomized, meaning assigned by chance, like flipping a coin so you do not get to choose which group you are in nor does your doctor. The study is trying to determine if using the pacemaker to control your heart rate can help you heart failure.

Your participation will last at least 18 months and may be as long as 4.5 years depending on when you join the study. The study will include about 8 visits and include the pacemaker implant procedure as well as testing such as physical exams, 6 minute walk test, echocardiograms (ultrasound test of your heart), blood work, questionnaires and pacemaker checks.

There are risks associated with the pacemaker implant procedure, risks related to study related procedures and the risk of loss of confidentiality. There may be benefit to you and to others with this condition in the future.

Institution
MUSC
Recruitment Contact
Krista Szymanski
843-876-6846
szymankr@musc.edu

BTX-302-001: A Phase 1/2 dose-exploration and dose-expansion study to evaluate the safety and efficacy of BEAM-302 in adult patients with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung disease and/or liver disease.

Date Added
September 9th, 2025
PRO Number
Pro00146485
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Liver, Lung, Pulmonary, Rare Diseases
Summary

BTX-302-001 is a research study investigating the safety (how many side effects participants may have) and tolerability (how tolerable the side effects are) of BEAM-302 for individuals with Alpha-1 Antitrypsin Deficiency (AATD)-associated lung and/or liver disease. This study also aims to gather additional information regarding how BEAM-302 moves through the participant's body, how long it stays, and how long it takes to eliminate it - which is defined as the study drug's pharmacokinetics or "PK". Researchers would like to determine through this research study how BEAM-302 impacts the disease course (progression) of AATD in terms of AATD blood biomarkers, which are substances in blood that the body normally makes and will help show if an individual's AATD is improving, staying the same, or getting worse, along with lung and liver function testing results and the quality of life of participants.

This research study will be split into two main parts, Part A (which is for individuals with AATD-associated lung disease with no clear evidence of AATD-associated liver disease) and Part B (which is for individuals with AATD-associated liver disease). Additionally, each Part will be split into two separate cohorts, where one cohort will receive a single intravenous (IV) infusion of BEAM-302 (single-dose cohort) and the other will receive two IV infusions of BEAM-302 approximately 8 weeks apart (multi-dose cohort). Within these cohorts (single-dose and multi-dose), there are also separate smaller cohorts that will vary by the dose of BEAM-302 administered to participants, so a participant in this study could receive any of the following dosages - 15mg, 30mg, 60mg, 75mg, or 90mg. Overall, the research study will last up to around 29 months for each participant, depending on which cohort they are in, and their participation will be split into three main study periods - Screening, Dose and Dose-limiting toxicity (DLT), and Follow-up. It is also important to note that when a participant is receives their infusion(s) of BEAM-302 during the Dose and DLT period, the administration of the study drug will be done as a part of an in-patient hospital stay that will last up to 48 hours so that they can be closely monitored by the study team.

The key eligibility criteria for this study are that individuals (male or female) must be 18 to 70 years old, possess the PiZZ type of AATD, and have either AATD-associated lung disease with no clear evidence of AATD-associated liver disease or AATD-associated liver disease. There are additional eligibility criteria that must be met in order to be able to participate in the study, which will be assessed across up to 2 study visits that will occur during the Screening period.

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8432
blantonm@musc.edu

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Date Added
September 12th, 2025
PRO Number
Pro00142574
Researcher
James Bowsher

List of Studies

Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

Children with amblyopia (lazy eye) are often treated with patch therapy. Patch therapy often results in leftover amblyopia and has many challenges associated with its use. This study will determine how traditional patch therapy results compare to those achieved with the Luminopia digital therapeutic system.

Institution
MUSC
Recruitment Contact
Martha Long
8437926591
mas405@musc.edu

BabySTrong (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding

Date Added
September 16th, 2025
PRO Number
Pro00146417
Researcher
Dorothea Jenkins

List of Studies


Keywords
Infant, Nerve
Summary

Preterm and term infants with brain injury frequently have difficulty learning to feed by mouth. Transcutaneous vagus nerve stimulation (taVNS) may be paired with the motor activity of feeding to boost brain circuits involved with feeding. This study will test a taVNS-paired bottle system in a blinded, randomized, controlled trial in infants who have reached term age and failed to learn to feed. Our preliminary data indicates that most infants improve their volume of oral feeds with the BabySTrong system, and 50-70% achieve full oral feeds and avoid placement of a gastrostomy tube (G-tube) or home nasogastric tube. The BabySTrong feeding system may improve oral feeding volumes and help infants and their families avoid a long hospital stay while trying to learn to feed.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-792-2112
boatrigh@musc.edu

A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Date Added
September 16th, 2025
PRO Number
Pro00141315
Researcher
James Bowsher

List of Studies

Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

Children with amblyopia (lazy eye) are often treated with patch therapy. Patch therapy often results in leftover amblyopia and has many challenges associated with its use. This study will determine how traditional patch therapy results compare to those achieved with the Luminopia digital therapeutic system.

Institution
MUSC
Recruitment Contact
Martha Long
843-792-6591
mas405@musc.edu



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