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

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

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 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Date Added
April 9th, 2026
PRO Number
Pro00149000
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Liver, Lung, Pulmonary, Rare Diseases
Summary

This is a Phase 1/2, open-label, multi-center clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of TSRA-196, a gene editing compound, in adults with severe alpha-1 antitrypsin deficiency (PiZZ genotype) and associated lung and/or liver disease. Participants will receive a single intravenous dose of TSRA-196 in a dose-escalation phase followed by dose-expansion cohorts.

The study will assess safety outcomes, pharmacokinetics, and changes in serum alpha-1 antitrypsin levels and lung function to determine whether TSRA-196 can safely increase functional AAT levels and inform selection of an appropriate dose for further clinical development.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@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

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

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

An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer.

Date Added
March 12th, 2026
PRO Number
Pro00148604
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 diagnosed with primary advanced or recurrent endometrial cancers that express high levels of the human epidermal growth factor receptor 2 (HER2) protein and that have a genetic characteristic known as mismatch repair proficiency (pMMR). The study is testing investigational drugs called Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The purposed of this study is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy. The study drugs are given by infusion. Participants in this study can expect to be in this study for as long as you are receiving benefit from the treatment.

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

A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)

Date Added
March 11th, 2026
PRO Number
Pro00149360
Researcher
Katherine Antel

List of Studies

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

This study is for patients that have been newly diagnosed with GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL). This study is testing an investigational drug called zilovertamab vedotin. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). In the study, participants will be randomized to two different groups (like flipping a coin). The first group will receive zilovertamab vedotin plus R-CHP [rituximab, cyclophosphamide, doxorubicin, and prednisone]. The second group will receive the standard care regimen: polatuzumab vedotin plus R-CHP. The drugs will be given through an IV, and prednisone may be given to participants by mouth. The primary purpose of the study is to learn if zilovertamab vedotin plus R-CHP is safe and effective for treating DLBCL. Participants in this study can expect to be in this study for up to 5.5 years. The first six months will be participation in treatment, and the following five years will be follow-up.

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



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