A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients with Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS)

Date Added
March 27th, 2026
PRO Number
Pro00150201
Researcher
Alexandra Kejner

List of Studies

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

This study is for patients diagnosed with recurrent/persistent PD-LI enriched squamous cell carcinoma of the head and neck and undergoing salvage surgery. The purpose of this study is to compare the usual treatment of surgery alone, to using chemotherapy (cisplatin and paclitaxel) or chemo-immunotherapy [carboplatin and paclitaxel with cemiplimab (REGN2810)] plus the usual treatment.

Carboplatin, cisplatin, paclitaxel, and cemiplimab are FDA approved to treat head and neck cancers. This study seeks to answer if adding chemotherapy or chemo-immunotherapy before surgery extends the length of time without your cancer returning compared to the surgery alone.

Patients may participate in this study for up to 3 years. Procedures surgery, blood tests, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 180 people taking part in this study, approximately x participants will be enrolled at MUSC.

Risks include hair loss, diarrhea, nausea, vomiting, anemia, infection, and fever. Participants 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.

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

A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma

Date Added
March 27th, 2026
PRO Number
Pro00146919
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is testing whether adding a new drug, casdatifan, to cabozantinib works better than cabozantinib alone in adults with advanced kidney cancer (clear cell renal cell carcinoma) that has gotten worse after previous immunotherapy. It will compare the two treatments in patients around the world to see which is more effective. A total of 8 patients will be enrolled locally over the course of 26 months, and participants may be in the study for up to five years. Before joining, patients will complete a screening process with tests and assessments to determine eligibility. If eligible, participants will be randomly assigned to one of two groups: casdatifan plus cabozantinib or placebo plus cabozantinib. There is a 2 in 3 chance of being in the casdatifan group and a 1 in 3 chance of being in the placebo group. Both drugs are taken by mouth in pill form each day. During the study, patients will have assessments such as blood tests, imaging scans, heart monitoring, physical exams, biopsies, questionnaires, and a drug diary. Participants will visit the study site two times each 28-day cycle for the first two cycles, then once per cycle thereafter. The most important risks include low blood counts, low oxygen levels, fatigue, gastrointestinal problems, skin reactions, high blood pressure, weight loss, voice changes, and bleeding.

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

An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept when Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)

Date Added
March 26th, 2026
PRO Number
Pro00150204
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary, Pulmonary Hypertension
Summary

This is a Phase 3, open-label, follow-up study to evaluate the long-term safety,
tolerability, and efficacy of sotatercept when added to background PAH therapy for the treatment of PAH. Participants enrolled in this study are from the following parent studies: PULSAR, SPECTRA, STELLAR, HYPERION, and ZENITH. Participants eligible to enroll in this study will have participated in and completed the requirements of the MK-7962-004 study (Amendment 07 or later). In this study, participants will receive open-label sotatercept . The duration of participation for each participant will vary based on their enrollment date, but it is anticipated to be up to 3 years.

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

A long-term non-interventional study to assess the incidence of skin malignancies in patients with dystrophic and junctional epidermolysis bullosa receiving treatment with Filsuvez (FOSTER)

Date Added
March 26th, 2026
PRO Number
Pro00149282
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This observational, multi-country cohort study examines the long-term safety of Filsuvez in real-world clinical practice. Researchers will collect both primary data and use existing patient registry data to gather information on Filsuvez exposure, skin malignancies, medical history, and other clinical characteristics. The study will include patients with confirmed diagnoses of DEB and JEB, regardless of whether they use Filsuvez, as long as they meet the approved indication. Patients previously exposed to Filsuvez through clinical trials, early access programs, or compassionate use programs may also participate. The study does not require any protocol-mandated visits or procedures, and the frequency of patient visits will follow local standard practice and individual patient needs.

Institution
MUSC
Recruitment Contact
Emma Edwards
8438769302
edwaremm@musc.edu

The RESTORE ("REducing future fractureS and improving ouTcOmes of fRagility fracturE") Protocol will serve as the written guidelines for study processes and procedures.

Date Added
March 25th, 2026
PRO Number
Pro00149331
Researcher
Jyotika Fernandes

List of Studies


Keywords
Bone
Summary

This study will recruit 2,634 participants,50 years of age or older, who have sustained a primary fragility fracture of the hip, femur, pelvis, clinical spine, humerus, or wrist in the last 12 months. Participants will be recruited from approximately 20 sites around the United States. Patients will be randomized to either continue treatment with "Augmented Fracture Liaison Service" or to continue with "Enhanced Usual Care." Both pathways incorporate patient education about the high risk of future fractures and available treatment approaches for fracture risk reduction. Patient education materials, in English or Spanish, will include information about fractures, bone health and osteoporosis, and will refer participants to resources to provide additional education on ways to reduce the risk of another fracture. Both arms of the study will be mailed education materials after enrollment. Study participation will consist of surveys over the course of 2 years, and a visit to a bone health specialist.

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

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

Date Added
March 24th, 2026
PRO Number
Pro00150045
Researcher
Thai Ho

List of Studies

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

This study is for patients that have been diagnosed with diagnosed with unresectable, locally advanced, recurrent or metastatic renal cell carcinoma (RCC). The study is testing investigational drugs called pumitamig."Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The main purpose of this study is to evaluate the safety and tolerability, and to determine the recommended phase 2 dose (RP2D), of pumitamig administered in combination with ipilimumab or cabozantinib. The study drug is given by infusion. Participants in this study can expect to be in this study for about 4 years.

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

Optimizing Clinical Screening for Body Image Distress Among Head and Neck Cancer Survivors: Implementation of a Short Form of the IMAGE-HN Questionnaire

Date Added
March 24th, 2026
PRO Number
Pro00149346
Researcher
Haley Hullfish

List of Studies

Keywords
Cancer/Head & Neck
Summary

This study is designed to improve how body image distress is identified among adult survivors of head and neck cancer during routine clinic visits. Participants will complete questionnaires about body image concerns either on paper or electronically (in clinic or remotely through a secure link). The study will evaluate how well a brief screening questionnaire (IMAGE-HN SF) identifies patients experiencing meaningful body image distress compared with the longer, full IMAGE-HN survey. In addition to assessing how accurately the short form performs, we will ask patients how they prefer the screening to be delivered, including the timing, format, and method of completion in routine care. A subset of participants will be invited to complete a short interview to share additional thoughts about how this type of screening should be implemented. Findings from this study will help guide the use of efficient and patient-centered body image screening in head and neck cancer clinics.

Institution
MUSC
Recruitment Contact
Haley Hullfish
843-278-3842
hullfish@musc.edu

Prospective Observational Study on the Natural History of Alpha-1 Antitrypsin Deficiency and Associated Liver Disease (ALPHATUDE)

Date Added
March 20th, 2026
PRO Number
Pro00147215
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Pulmonary, Rare Diseases
Summary

This an observational study collecting data for up to 8 years on patients who have been diagnosed with PiZZ or PiSZ Alpha-1 Antitrypsin Deficiency with or without liver disease. Patients' clinical, medical, and laboratory data will be collected prospectively per routine care and questionnaires will be collected during the clinic visits with the hopes of getting a better understanding of the natural progress of lung and liver disease associated with Alpha-1 Antitrypsin Deficiency.

Institution
MUSC
Recruitment Contact
Gwen Hayden
843-792-8438
blantonm@musc.edu

A Descriptive Study Assessing Sexual Activity Following Sacrocolpopexy

Date Added
March 19th, 2026
PRO Number
Pro00148799
Researcher
Amy Askew

List of Studies

Keywords
Sexual Dysfunction, Women's Health
Summary

This is a descriptive study designed to determine the proportion of women who are sexually active after minimally invasive sacrocolpopexy, with particular focus on those aged 65 and older. Because sacrocolpopexy carries certain risks—especially in older women—but also preserves vaginal length and may improve sexual function, understanding post-surgical sexual activity can help clinicians counsel patients when choosing between reconstructive surgeries, which preserve vaginal length, and obliterative surgeries, which do not. The study also aims to better understand patient values in surgical decision-making related to sexual activity. Women who had sacrocolpopexy at MUSC since January 1, 2015 will be contacted to complete two questionnaires: one assessing sexual activity and satisfaction with surgery, and one assessing sexual function using an adapted PISQ-IR questionnaire. Data will be analyzed using descriptive and comparative statistics to examine the proportion of sexually active women in groups under 65 versus 65 and older, as well as to compare their sexual function outcomes.

Institution
MUSC
Recruitment Contact
Addison McFarland
312-282-5522
mcfaradd@musc.edu

PRIMary care Engagement in Survivorship (PRIMES): A Mixed Methods Study

Date Added
March 18th, 2026
PRO Number
Pro00149836
Researcher
Michelle Mollica

List of Studies


Keywords
Cancer/Gastrointestinal, Healthy Volunteer Studies, Non-interventional
Summary

This study aims to improve cancer survivorship care work by refining how primary care providers and cancer specialists share responsibilities. Researchers want to understand how technology can help these teams communicate more clearly and effectively to coordinate care for survivors. The study team will use surveys, conduct interviews and organize focus groups for interested and eligible participants as methods of data collection to inform the research. Oncologists, Primary Care Physicians, administrative leads and colon or rectal cancer survivors that meet the eligibility criteria will complete surveys, engage in interviews and group discussions from each perspective to learn strategies to improve care, including who should handle which parts of survivorship care. Using this information, the team will create an intervention plan called PRIMES that outlines strategies to overcome common barriers. The ultimate goal is to help survivors receive better and more coordinated follow‑up care.

Institution
MUSC
Recruitment Contact
Mary Chris Pittman
843-792-3512
pittmama@musc.edu



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