AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer

Date Added
April 17th, 2026
PRO Number
Pro00147118
Researcher
Kevin Becker

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

This study is for patients who have been diagnosed with prostate cancer that is prostate-specific membrane antigen (PSMA)-positive and has spread despite treatment with another androgen receptor pathway inhibitor (ARPI). This study is testing an investigational drug called AAA817. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In this study, participants will be randomly assigned (like flipping a coin) to receive AAA817 alone, AAA817 with an androgen receptor pathway inhibitor (ARPI), or standard of care treatment. The primary purpose of this study is to determine whether AAA817, given alone or in combination with an ARPI, is safe and effective compared to standard of care treatments. This drug is given to participants as a radioligand therapy infusion. Participants in this study can expect to be in the study for up to 6.1 years, including two visits before starting treatment, visits every 4 weeks during treatment, and visits every 12 weeks during long-term follow-up for up to 5 years after treatment ends.. There will be a total of 9 patients enrolled locally.

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

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination with Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination with Darolutamide Versus Darolutamide Alone in Patients with Metastatic Hormone Sensitive Prostate Cancer

Date Added
April 17th, 2026
PRO Number
Pro00147949
Researcher
Kevin Becker

List of Studies

Keywords
Cancer, Men's Health, Prostate
Summary

This study is for patients who have been diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC).This study is testing an investigational drug called Tulmimetostat, which will be given in combination with standard prostate cancer treatments: Darolutamide or Abiraterone. "Investigational" means that Tulmimetostat has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the safety and potential benefits of Tulmimetostat when given with Darolutamide or Abiraterone. The study will also evaluate whether adding Tulmimetostat can delay the progression of prostate cancer compared to treatment with Darolutamide alone. Participants will receive the study drug by mouth, along with standard androgen deprivation therapy (ADT). Those receiving abiraterone will also take a low-dose corticosteroid (prednisone or prednisolone) to help prevent side effects. Participants can expect to be in the study as long as they are benefiting from treatment or until the study ends. During the first 4 weeks, study visits will occur on Days 1, 2, 8, 15, and 22. Beginning with Cycle 2, participants will have visits on Day 1 of every 4-week cycle. At study visits, participants will undergo health assessments such as physical exams, blood and urine tests, heart monitoring (ECG), imaging scans (CT or MRI), and health questionnaires. Some participants may also have an optional biopsy. A total of 8 patients will be enrolled locally over the course of 32 months.

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

A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer

Date Added
April 16th, 2026
PRO Number
Pro00150355
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with squamous cell, adenocarcinoma, or adenosquamous cervical cancer. This study is testing an investigational drug called pembrolizumab. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). A computer will be used to assign you to one of the study groups. This process is called "randomization." Like flipping a coin, everyone has an equal chance of being placed in any group. The primary purpose of this study is to determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiotherapy plus immunotherapy (CCRT+IO) improves progression-free survival (PFS) compared to CCRT+IO alone. The study drug is given by infusion. Participants in this study can expect to be on the study for 7 years.

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

A Multi-Center Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients with Suspected Clonal Mast Cell Disease

Date Added
April 15th, 2026
PRO Number
Pro00149043
Researcher
Alexander Coltoff

List of Studies

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

This study is for participants with symptoms of mast cell activation (SMAC). The primary purpose of this study is to learn about clonal mast cell diseases. Clonal mast cell diseases are hard to diagnose because symptoms are not specific, and they can overlap with other diseases. The tools currently used by doctors to look for clonal mast cell diseases in the blood may not identify all patients. This study is being done to develop an investigational blood test that looks for a change in a gene called KIT. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Two types of blood tests will be compared against each other. Participants in this study can expect to be in this study for about 6 months.

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

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy

Date Added
April 9th, 2026
PRO Number
Pro00149086
Researcher
Anthony Dominick

List of Studies

Keywords
Cancer
Summary

This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.

Institution
MUSC
Recruitment Contact
Thomas Hortman
8437929300
hortman@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



-- OR --