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

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

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

Empathic Communication Skills Training to Reduce Lung Cancer Stigma

Date Added
March 25th, 2026
PRO Number
Pro00146703
Researcher
Kathryn Engelhardt

List of Studies

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

This study is for patients and providers. It will evaluate Empathic Communication Training (ECT) a new training for cancer providers that aims to improve care providers' awareness and understanding of lung cancer stigma while developing their skills to communicate empathically with patients. The study will provide information about whether Empathic Communication Training (ECT) in care providers is associated with improved outcomes for lung cancer patients. The study will include two groups: lung cancer patients and cancer care providers. Patients may experience the risk of lost time at work, school, or at home, and you may spend more time than usual in the hospital or doctor's office. This study will enroll 66 patients locally for 12 months.

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

Omission of Post-Operative Radiation in Patients with Intermediate Pathological Risk Features and Negative Two Week Post-Operative ctHPVDNA (OPERATION Trial)

Date Added
March 17th, 2026
PRO Number
Pro00149196
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer
Summary

This study is for adult patients with Oral Squamous Cell Carcinoma (OSCC). The purpose of this study is to use results from a CLIA regulated blood test (NavDx) to measure tumor DNA to omit postoperative radiotherapy following surgery. Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. Participation in this study is anticipated to last approximately 2 years with a 3 year follow up period.

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

A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination with Immune Checkpoint Inhibition in Participants with Locally Advanced or Metastatic Refractory Solid Tumors

Date Added
March 12th, 2026
PRO Number
Pro00149087
Researcher
Christopher Rangel

List of Studies

Keywords
Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Gynecological, Cancer/Lung, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with locally advanced or metastatic solid tumor, including non-small cell lung cancer (NSCLC), triple-negative breast cancer, gastric cancer, esophageal cancer (or gastroesophageal cancer), head and neck squamous cell cancer, ovarian cancer, endometrial cancer, or cervical cancer. The study is testing and investigational drug called NRM-823. "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 and tolerability of NRM-823 as monotherapy and in combination with pembrolizumab. The study drug is given as an injection into the stomach (or another place, like the thigh). An injection is like a shot between the skin and muscle so that the drug can enter your body. Participants can expect to be on this study until the first radiographic disease progression.

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



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