Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

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

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer

Date Added
April 2nd, 2025
PRO Number
Pro00142948
Researcher
Theodore Gourdin

List of Studies


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

This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.

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

3D CTA Fusion for Prostate Artery Embolization: A Randomized Controlled Trial

Date Added
April 1st, 2025
PRO Number
Pro00140426
Researcher
Stephen Stringfellow

List of Studies

Keywords
Men's Health
Summary

This research study is focused on evaluating the effectiveness of a new imaging technique for a procedure called Prostate Artery Embolization (PAE), which is used to treat an enlarged prostate. The study compares two groups of patients: one group receives PAE with advanced imaging called 3D CTA fusion, and the other group receives PAE using the standard imaging method. The goal is to determine if using 3D CTA fusion can make the procedure faster, reduce the amount of radiation exposure, and decrease the need for contrast dye during the procedure. By studying these two groups, researchers hope to identify ways to make PAE safer and more efficient​

Institution
MUSC
Recruitment Contact
Derek Groskreutz
8432437260
groskreu@musc.edu

Randomized Phase III Study of Mosunetuzumab vs. Rituximab for low Tumor Burden Follicular Lymphoma

Date Added
March 6th, 2025
PRO Number
Pro00142136
Researcher
Brian Hess

List of Studies


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

This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.

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

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Date Added
March 5th, 2025
PRO Number
Pro00138827
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. 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

An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

Date Added
February 25th, 2025
PRO Number
Pro00141996
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to evaluate investigational treatments (study drug) in people with subjects with c-Met over-expressed refractory metastatic colorectal cancer

The purpose of this study is to determine the recommended ABBV-400 dose when ABBV-400 is given alone (monotherapy) in Stage 1, and to assess if ABBV-400 monotherapy is a safe and effective treatment compared to the standard of care (SOC) LONSURF [Trifluridine and Tipiracil] plus Bevacizumab in subjects with c-Met overexpressed (level of c-Met protein in your tumor cells is increased) uncontrolled metastatic colorectal cancer in Stage 2 of the study plan.

This is a phase 3 study; ABBV-400 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 3 years. The procedures include taking study drug intravenously, blood and urine samples, MUGA scans and CT scans. Risks include diarrhea, nausea, vomiting, anemia, muscle aches, and joint pain. You 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 Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. 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, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease.

Date Added
December 27th, 2024
PRO Number
Pro00140678
Researcher
Kimberly Green

List of Studies

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

This study is for participants who have moderate or severe chronic graft-versus-host disease (cGVHD). cGVHD is a condition in which the healthy transplanted (graft) stem cells see the recipient's (host) cells as foreign and start to destroy them.
This Study is being done to learn the effects of the drug INCA034176 (also known as axatilimab) in combination with corticosteroids.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9300
salzers@MUSC.edu

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
December 18th, 2024
PRO Number
Pro00141575
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to evaluate investigational treatments (study drug) in people with recurrent or metastatic PD-L1-positive, HPV-negative head and neck squamous cell carcinoma without prior treatment. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BCA101. This is a phase 2 study; BCA101 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 5 years. The procedures include taking study drug intravenously, blood and urine samples, and CT scans. Risks include diarrhea, nausea, vomiting, mouth sore, nose bleed, headache, and skin rash. You 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

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing with a Left Ventricular Epicardial Lead in Patients with Heart Failure (HF) with Left Ventricular Ejection Fraction (LVEF) ≤ 50% and with either a Wide QRS Complex (> 130 ms) or with/anticipated > 40% Pacing Randomized Clinical Trial (RCT) (Left vs Left RCT)

Date Added
December 17th, 2024
PRO Number
Pro00140157
Researcher
Anne Kroman

List of Studies

Keywords
Cardiovascular, Heart, Men's Health, Women's Health
Summary

The purpose of this study is to determine if patients with heart failure (HF, meaning a weak heart) with left ventricular ejection fraction (LVEF) ≤ 50% and with an abnormal heart beat can benefit from having pacemaker leads placed in a different location in the heart. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. Participants in this study will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:
A. Pacing the heart from two locations in the left ventricle (lower left chamber of the heart)
B. Pacing the heart from one of two other places in the heart (the "His" or the left bundle branch)

The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
washoliv@musc.edu



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