SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

SPECIMEN COLLECTION FROM PARTICIPANTS DUE FOR COLORECTAL CANCER SCREENING, SURVEILLANCE, OR TREATMENT: "IMPACT"

Date Added
August 27th, 2025
PRO Number
Pro00143588
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer, Cancer/Gastrointestinal
Summary

The purpose of the study is to help to develop a new test that may help with early colorectal cancer detection. This will be done by collecting a blood sample, a stool sample, and other sample types, and comparing the results to hopefully identify a biomarker that can detect cancer more easily than current standards.

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

PHASE II STUDY EVALUATING NALIRIFOX VS. MODIFIED GEMCITABINE, NAB-PACLITAXEL, AND CISPLATIN IN PATIENTS WITH LOCALLY ADVANCED AND METASTATIC PANCREATIC ADENOCARCINOMA

Date Added
August 19th, 2025
PRO Number
Pro00145838
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Drug Studies, Pancreas
Summary

This study is for patients that have been diagnosed with previously untreated, locally advanced, and metastatic pancreatic ductal adenocarcinoma PDAC. This study is testing two treatment regimens: NALIRIFOX (5-fluorouracil, liposomal irinotecan, oxaliplatin, and leucovorin) vs mGAP (gemcitabine, nab-paclitaxel, and cisplatin).
The primary purpose of this study is to see which of the two regimens is more effective in PDAC. Participants will continue on study medications if seeing clinical benefit, and can expect to be on the study for a maximum of 6 months.

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

A Randomized Phase II Study of Venetoclax and HMA-based Therapies for theTreatment of Older and Unfit Adults With Newly Diagnosed for FLT-3 Mutated Acute Myeloid Leukemia (AML): a MyeloMATCH Treatment Trial

Date Added
August 19th, 2025
PRO Number
Pro00146654
Researcher
Praneeth Baratam

List of Studies

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

This phase 2 study is enrolling patients who have acute myeloid leukemia (AML) with certain biomarkers. This study is being done to see the effectiveness of different combinations of drugs to treat AML. It will involve 3 groups of patients receiving different combinations of Gilteritinib, Azacitidine and Venetoclax. Gilteritinib is an investigational drug, Azacitidine and Venetoclax are FDA approved. The main purpose of the study is to see if the amount of leukemia in the patient's body can be lowered by adding the drug Gilteritinib to the Standard of Care of treating AML with Azacitidine and Venetoclax. The study will include approximately 147 patients. The patients will be randomized into the three groups (like flipping a coin), Group 1 will receive just Azacitidine + Venetoclax, Groups 2 and 3 will also receive Gilteritinib but Group 2 will receive it for more time within a treatment cycle. Patients will complete screening after participating in this treatment trial or SOC therapies. Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that the study drugs may not be as good as the usual approach for their cancer or condition at shrinking or stabilizing their cancer. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

SHORT TERM INTENSIFIED PEMBROLIZUMAB (KEYTRUDA) AND TIVOZANIB FOR HIGH-RISK RENAL CELL CARCINOMA - STRIKE

Date Added
August 12th, 2025
PRO Number
Pro00146260
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is patients that have been diagnosed with high-risk renal cell carcinoma. This study will compare disease free survival (DFS) in patients treated with adjuvant pembrolizumab and tivozanib versus those receiving pembrolizumab alone. Participants can expect to remain in the study for 10years. There will be a total of 14 patient enrolled locally.

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

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 11th, 2025
PRO Number
Pro00146236
Researcher
Jonathan Alexander

List of Studies

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

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MyeloMATCH Clinical Trials

Date Added
August 11th, 2025
PRO Number
Pro00146515
Researcher
Praneeth Baratam

List of Studies

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

This phase 2 study is screening patients who may have acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This study is a non-treatment protocol and the first step of taking part in myeloMATCH, which is a clinical trial. The main purpose of the study is to see if testing on patient's bone marrow and blood results in finding certain biomarkers that will qualify participants for the treatment study or for Standard of Care (SOC) therapies. The study will enroll approximately 5000 patients. The study has two periods, initial and post-treatment screening. It takes about four days for the study doctor to receive the screening results and the patient's first treatment assignment in myeloMATCH. Patients will complete post-treatment screening after their participation in treatment trials or SOC therapies. It will take about 11 days for the study doctor to receive these results and decide their next treatment assignment. Further testing may match patients with myeloMATCH substudies in the future. The main risk is that biomarker test results may be wrong. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumab vs. Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naive Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Related Head and Neck Squamous Cell Carcinoma (HNSCC)

Date Added
August 8th, 2025
PRO Number
Pro00145400
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to test the effectiveness and safety of the combination of an investigational vaccine, PDS0101, given by subcutaneous (beneath the skin) injection and the standard of care, Pembrolizumab (KEYTRUDA), given intravenously ("IV;" into the vein) compared to pembrolizumab (KEYTRUDA) alone for those with unresectable recurrent or metastatic head and neck cancer and high risk papillomavirus infection. "Investigational" means the combination of the study vaccine and pembrolizumab being tested has not been approved by the US Food and Drug Administration (FDA) nor any other Health Authority.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@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

The Effectiveness of screening women with lower genital tract neoplasia or cancers for anal cancer precursors.

Date Added
August 1st, 2025
PRO Number
Pro00131770
Researcher
Ashish Deshmukh

List of Studies

Keywords
Cancer, Cancer/Gynecological
Summary

The goal of this study is to utilize prospectively collected information from a multisite single-arm trial of 300 HIV uninfected people assigned female gender at birth with lower genital tract neoplasia ("WLGTN") to conduct a unique multidisciplinary study that will clarify issues surrounding anal cancer screening tests in this population as well as help to comprehend the natural history of anal dysplasia among WLGTN. This single arm clinical trial will evaluate screening (diagnostic) tests for anal cancer screening in a population that is not currently routinely screened, determine the prevalence and incidence of aHSIL and
collect data regarding the acceptability of different anal cancer screening approaches. The initial screening interventions will include the collection of (1) anal cytology, obtained by clinician using a water moistened cytobrush; (2) self-collected HPV testing specimens (by subjects, using a Dacron swab); (3) a clinician collected HPV specimen. Anal specimens will be collected by insertion of the cytobrush or moistened Dacron swab into the anal canal until resistance is not met; approximately 5 cm. These tests are followed by a brief standardized exam to determine any external anogenital lesions or pathology, performed by the investigator conducting anoscopy. A digital rectal exam will also be done on all patients. Results of these tests will be confirmed in all patients using high resolution anoscopy (HRA) with biopsy of suspicious lesions. Following standard practices, subjects are treated with 3% acetic acid and Lugol's iodine.

Institution
MUSC
Recruitment Contact
Alexis Nuzzo
123-456-7890
nuzzo@musc.edu



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