TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)

Date Added
October 14th, 2025
PRO Number
Pro00146373
Researcher
Daniel Judge

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with symptomatic ATTR-CM (transthyretin amyloidosis cardiomyopathy). ATTR-CM is a rare and serious disease that occurs when a protein in the blood called transthyretin (TTR) builds up throughout the body, including in the heart and nerves. When the abnormal protein, known as amyloid, deposits in the heart, the heart muscle thickens and stiffens, causing the heart to fail. This research study is designed to test whether the medication nucresiran is safe and helps people with ATTR-CM, in comparison to the effects of placebo.

Nucresiran is considered investigational, meaning it is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of ATTR-CM. Nucresiran is a TTR silencer. It is like a "quiet button" that turns down the amount of the disease-causing protein that is made. Because there is less TTR, there may be less buildup in the heart and other organs over time.

This is a randomized study meaning once eligibility is confirmed, participants will be assigned by chance, like drawing straws, to either receive nucresiran or placebo. You will have a 2 out of 3 chance of being assigned to nucresiran and a 1 out of 3 chance of being assigned placebo. Placebo is a substance that looks like the actual medication and is given the same way but contains no active substance. The study drug, which can be either nucresiran or placebo, will be given as an injection under the skin in the abdomen (avoiding the area around the navel), thigh, or the side or back of the upper arms. Neither the participants nor the study doctor will know who is assigned to nucresiran or placebo but this information can be made available if need be.

Participation in this study is expected to last for 5-8 years, Study related procedures include physical exams, vital signs, echocardiograms (ultrasound test of the heart), electrocardiograms, (ECG, a tracing of the heart's electrical activity), blood work, urine samples and questionnaires. Participants will also take Vitamin A daily. Study related risks include risks related to the study drug including injection site reactions, abnormal liver function or an allergic reaction. There may be risks related to study procedures including loss of confidentiality. There may not be any direct benefit, but the information learned may benefit others with ATTR-CM in the future.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

Protocol S2414, A Randomized Phase III Trial Incorporating Pathologic Complete Response in Participants with Early Stage Non-Small Cell Lung Cancer to Optimize Immunotherapy in the Adjuvant Setting (INSIGHT) (NCT06498635)

Date Added
October 22nd, 2025
PRO Number
Pro00147635
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung
Summary

This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.

Institution
MUSC
Recruitment Contact
maggie bentley
864-725-7125
margaret.bentley@selfregional.org

A Randomized Phase II Study of Nivolumab versus Nivolumab and BMS-986016 (Relatimab) as Maintenance Treatment after First-line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus- Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

Date Added
November 14th, 2025
PRO Number
Pro00146870
Researcher
John Kaczmar

List of Studies


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

This study is for subjects who have been diagnosed with recurrent or metastatic nasopharyngeal cancer. Subjects are expected to remain in the study for a minimum of 70 months. Drugs are FDA approved and is given through a vein (also called IV or intravenous). The procedures include blood and urine tests, troponin test. Risks include infection, bruising, bleeding, anemia, kidney damage, hearing loss, nausea, vomiting, numbness, pain, rash, blood in urine. You may not receive a benefit from participating in this trial, however, information learned from the trial may help other people in the future.

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

A032302: Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Date Added
November 14th, 2025
PRO Number
Pro00148191
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Genitourinary
Summary

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Institution
MUSC
Recruitment Contact
maggie bentley
864-725-7125
margaret.bentley@selfregional.org

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Platinum Refractory Disease

Date Added
November 18th, 2025
PRO Number
Pro00147980
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

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

AYA Access: An Enhanced eHealth and Chat-Bot Enabled Delivery Model for Clinical Genetic Services in Community AYA Cancer Patients

Date Added
December 2nd, 2025
PRO Number
Pro00147923
Researcher
Kevin Hughes

List of Studies

Keywords
Cancer, Genetics
Summary

This study is for adults aged 18 to 39 who have a history of cancer and have not had inherited cancer genetic testing. The purpose of this study is to find out if a digital tool can be used as an alternative to meeting with a genetic counselor before inherited cancer genetic testing, and whether this approach can help support patients through the testing process. The study will compare the digital tool to the usual approach for genetic testing, which involves meeting with a genetic counselor before and after testing.

Participants will be randomly assigned (like flipping a coin) to one of two groups. One group will receive pre-test education through a digital tool, and the other group will meet with a genetic counselor through a telehealth visit. All participants will receive their genetic test results through a telehealth visit with a genetic counselor. Participants in the digital tool group will also have access to a chatbot called the Genetics Journey Chatbot that provides educational support, reminders, and answers to questions during the study.

The study involves completing surveys at several time points: before genetic testing, after the testing decision, after receiving results, and again about 6 and 12 months later. The total duration of participation is about 18 months.

This study does not involve an investigational drug. Participants may benefit from learning whether they have a genetic change that could increase their risk of cancer, which could inform their future screening or prevention options. The information learned from this study may also help improve genetic testing delivery for future patients.

There will be a total of 10 patients enrolled locally over the course of 24 months.

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

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

Date Added
December 9th, 2025
PRO Number
Pro00148422
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.

This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.

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

An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn's Disease (VECTORS)

Date Added
December 11th, 2025
PRO Number
Pro00147428
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

The purpose of this research study is to determine the best treatment goals for patients with active CD. Researchers are investigating how treating and monitoring CD to meet specific treatment goals will keep your disease under control (remission) and decrease complications such as hospitalizations and surgeries. Group 1 treatment goals include IUS response (if the drug is improving your CD) and IUS assessed transmural healing (healing of all bowel layers), clinical remission (normalization of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission. Comparing the treatment goals in these groups may inform doctors how best to manage CD in the future. Approximately 304 people will be enrolled in this study. This research study will involve receiving 300 mg of vedolizumab as an intravenous (IV) infusion into your arm at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.

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

Transdisciplinary Oral/Oropharyngeal lesions Research & Care in Head and Neck Cancer (TORCH 2.0): A Prospective Non-Randomized Cohort Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC)

Date Added
January 6th, 2026
PRO Number
Pro00147748
Researcher
Dauren Adilbay

List of Studies

Keywords
Cancer/Head & Neck
Summary

This study will recruit adults diagnosed with an oral potentially malignant disorder (OPMD). The purpose of this research study is to collect blood, saliva, and tissue samples to determine whether certain measurable characteristics (biomarkers) can be identified which may provide insight into the risk of developing cancer. Participation in this study is expected to last approximately 3 years.

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

Perinatal Mental Health and Trauma-Informed Care: Assessing mental health symptoms, treatment seeking, and intervention needs

Date Added
January 7th, 2026
PRO Number
Pro00147901
Researcher
Cristina Lopez

List of Studies


Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study aims to explore the prevalence of mental health symptoms, including trauma exposure and posttraumatic stress symptoms in a postpartum population. The study also aims to collect information related to medical and mental health treatment seeking before, during, and after pregnancy as well as feedback on adaptations of future mental health interventions delivered during the postpartum period. Participation in this study includes a 35 minute online survey with questionnaires related to the study aims. Depending on survey responses, participants may be invited to complete an interview with study personnel to provide more specific insight on mental health treatments for perinatal individuals.

Institution
MUSC
Recruitment Contact
Cassidy Chesnutt
843-879-8749
brydonch@musc.edu



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