Randomized, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab and Docetaxel Versus Docetaxel Monotherapy in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

Date Added
February 18th, 2026
PRO Number
Pro00148285
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This research study is testing how well a combination of investigational drugs—N-803 and Tislelizumab with Docetaxel—works compared to Docetaxel alone in treating advanced non-small cell lung cancer (NSCLC). The drugs being studied are not yet approved by the FDA. Participants will be randomly assigned to one of two groups (like flipping a coin): the experimental group (receiving the drug combination) or the control group (receiving Docetaxel alone). For every 3 people, 2 will be randomized to the experimental group. You are being asked to join because your cancer has progressed after standard treatment and has become resistant to immune checkpoint inhibitors. Clinic visits will last about 3 to 4 hours and include routine tests and procedures. Treatment will continue until your cancer worsens, you experience severe side effects, choose to stop, or your doctor decides it's best to end treatment. After treatment ends, you'll have a follow-up visit and then be contacted every 3 months for up to 36 months to check on your health, either in person or via telemedicine. N-803 may cause side effects such as fever, high blood pressure, fatigue, itching, diarrhea, nausea, injection site reactions.

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

Epidermolysis Bullosa Clinical Characterization and Outcomes Database

Date Added
February 26th, 2026
PRO Number
Pro00142696
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

Epidermolysis Bullosa (EB) is a rare, inherited skin condition that makes the skin extremely fragile, causing painful blisters and wounds from even minor friction or injury. There is currently no cure, and because EB is uncommon, doctors still have limited high-quality data to guide the best treatment and long-term care. This study is part of a large North American effort to collect and organize health information from people with EB into a secure database. By tracking how the disease progresses over time, along with symptoms, complications, and treatments, researchers hope to better understand EB and improve care for future patients. Participation involves consenting to share medical record information and optionally completing brief questionnaires during routine clinic visits or by email. No experimental treatments or extra medical procedures are involved. While there is no direct benefit to participants, the knowledge gained may help improve care and support the development of new treatments in the future.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
843-792-2890
winelee@musc.edu

Adapting Written Exposure Therapy for Adolescents with Posttraumatic Stress Disorder

Date Added
March 3rd, 2026
PRO Number
Pro00149514
Researcher
Emily Tilstra-Ferrell

List of Studies

Keywords
Adolescents, Mental Health
Summary

Written Exposure Therapy (WET) is a five-session mental health therapy for post-traumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. Our study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, first we will talk with PTSD experts and people aged 12 to 18 to learn what changes might make WET more suitable for young people. We'll also deliver WET to five people aged 12 to 18 following the manual as it is written for people over age 18 to see what needs adjusting.

In the next part of the study, we will recruit 48 adolescents aged 12 to 18 in a pediatric primary clinic who have symptoms of PTSD and randomize them to either receive the adapted version of WET or to receive gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy. If assigned to receive adapted WET, participants will take part in five to seven weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30 weeks after starting the therapy). If assigned to receive TF-CBT, participants will take part in 12 to 16 weekly therapy sessions and five study visits (before therapy, and 6-week, 10-week, 20-weeks, and 30-weeks after starting the therapy). The purpose of the study visits for a 30-week time period is to better understand who they are as a person and their current mental health symptoms and diagnoses. All therapy and study visits can be completed remotely or in person, per your preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Our goal is to find the best way to provide effective PTSD treatment for young people that can be delivered in real-world pediatric primary care settings, so that ultimately more people can get the help they need after traumatic experiences.

Institution
MUSC
Recruitment Contact
Owen Winters
843-792-2615
winterso@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

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

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Kershaw Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

The Caris Biorepository Research Protocol

Date Added
March 31st, 2026
PRO Number
Pro00149599
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

The Caris Biorepository is collecting quality biospecimens, which can be any material that comes from human tissue, to bank for the purposes of future research studies related to advancing precision medicine and improving patient care. Select biospecimens may be collected from consenting individuals who have, or do not have cancer, are being screened for, or have an increased risk for a certain type of cancer. Samples may be used for research on: cells that make up your body (DNA and RNA) and how those cells and other cells work in healthy people and people with illness; how biomarkers might be able to predict the best treatments for a particular tumor type or blood finding; biomarker testing to discover and refine new technology; or, new discoveries and new biomarkers that can predict disease.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
balassom@musc.edu

High-Dose Nicotine Replacement Therapy for Quitting Cigarettes and E-cigarettes

Date Added
April 21st, 2026
PRO Number
Pro00150067
Researcher
Amanda Palmer

List of Studies

Keywords
Drug Studies, Smoking, Substance Use
Summary

Many people use both cigarettes and e-cigarettes (dual use) and want to quit both. However, little is known about the best way to support individuals who want to quit dual use. This study will test different doses of nicotine replacement therapy (patches and lozenges), a medication typically used for quitting smoking, to see which dose is best for people using both cigarettes and e-cigarettes. This study will also see if quitting cigarettes and e-cigarettes can lead to changes in health that might prevent cancer.

Institution
MUSC
Recruitment Contact
Rachel Bracci
(843)737-1516
chrisrac@musc.edu



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