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
Chandler Schwede
843-792-5998
schwede@musc.edu

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

Date Added
December 6th, 2024
PRO Number
Pro00137019
Researcher
Theodore Gourdin

List of Studies


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

This study utilizes adjuvant therapy in patients identified with urothelial cancer. Patients will be tested and screened to determine eligibility. Once they are deemed eligible and have consented to treatment, the study will begin. There are regular CT / MRI scans, blood draws, testing and drug administration that occurs while on this study, including while in post-treatment follow up. The study has seperated patients into Cohorts A and B. The study lasts approximately 5 years, with 2 years dedicated to regular treatment, and 3 to post-treatment follow up observation.

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

Evaluating INClisiran as a soLUtion to improve LDL-C management and cloSe care gaps in an Inclusive ASCVD and ASCVD risk equivalent populatiON (VICTORION-INCLUSION)

Date Added
November 26th, 2024
PRO Number
Pro00139806
Researcher
Ashley Waring

List of Studies

Keywords
Cholesterol, Drug Studies, Heart, Men's Health, Women's Health
Summary

This study is enrolling participants with heart disease or at high risk of developing heart disease who are already taking a cholesterol lowering medication referred to as a statin. This study is specifically seeking participants who are historically underrepresented in cardiovascular clinical trials including females, and racial/ethnic minorities, as well as those living in rural areas. This study involves the medication inclisiran which is an approved medication to help lower "bad" cholesterol. In this study participants will be randomized meaning assigned by chance to receive inclisiran along with usual care or not receive inclisiran and will continue usual care for the first 360 days. You will have a 50:50 chance, like flipping a coin, to receive inclisiran. Those participants who are randomized to not receive inclisiran initially will then receive it after day 360 and continue in the study for another 360 days so up to day 720. Participation will take up to 7 study visits.

Study related procedures include collecting medical history, demographics, questionnaires and blood work, as well as receive inclisiran as a shot just under the skin every 4 months. Study related risks include injection site reactions, joint pain or stiffness, bronchitis or an allergic reaction. There is also a risk of loss of confidentiality.

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

A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination with Durvalumab compared With Durvalumab as Maintenance Therapy in Subjects with Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Platinum, Etoposide and Durvalumab

Date Added
November 12th, 2024
PRO Number
Pro00136512
Researcher
Mariam Alexander

List of Studies

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

Researchers are investigating a new way to treat a type of lung cancer called small-cell lung cancer, which is very aggressive and often doesn't respond well to treatment. They're studying a drug called Tarlatamab, which targets a specific protein found on the cancer cells. This drug has already shown some promise when used alone, but now they're testing whether it works even better when combined with another type of cancer treatment called anti-PD-L1 therapy. This combination treatment might help the body's immune system fight the cancer more effectively. The hope is that by using these two treatments together, they can improve outcomes for people with small-cell lung cancer and give them a better chance of survival.

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

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR'S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

Date Added
November 6th, 2024
PRO Number
Pro00135996
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with mantle cell lymphoma that has spread and has not responded to treatment. This study is testing an "investigational" (not yet FDA approved) study drug called glofitamab. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR) or rituximab plus lenalidomide (R-Len;the control arm) on subjects with relapsed/refractory mantle cell lymphoma. Your total time in the study and the number of assessments in the follow up visits, will depend on how your MCL responds to study treatment. This could range from 1 day to more than 24 months. The screening period may last up to 28 days (4 weeks) and may involve more than one visit to the clinic.

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

A Randomized Phase III Trial of Doxorubicin +Pembrolizumab Versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

Date Added
October 25th, 2024
PRO Number
Pro00139599
Researcher
Christopher Rangel

List of Studies

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

This study if for patients with undifferentiated pleomorphic sarcoma (UPS) or a related poorly differentiated sarcoma that has spread from where it first started to other places in the body or it cannot be removed by surgery. This study compares the effect of pembrolizumab plus doxorubicin to doxorubicin alone in treating patients. Doxorubicin damages the cell's DNA and may kill tumor cells. Doxorubicin also blocks a certain enzyme needed for cell division and DNA repair. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to the standard chemotherapy, doxorubicin, may help patients with UPS or a related poorly differentiated sarcoma live longer without having disease progression. The duration of the study will be about 12 years, with 6 months of active treatment for those receiving doxorubicin alone and 2 years active treatment for those receiving doxorubicin and pembrolizumab. Each participant will be in follow up for 10 years. Some of the main side effects are nausea, vomiting, low blood count, fatigue and mild diarrhea.

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

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

Date Added
October 21st, 2024
PRO Number
Pro00138258
Researcher
Toros Dincman

List of Studies

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

The purpose of this study is to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer? ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

This study seeks to find if this approach is better or worse than standard of care for colon cancer.

Treatment and follow up for this study may be up to 8 years. The procedures include blood samples, tissue samples, and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, mouth sores, loss of appetite, tingling or pain in hands/feet/arms/legs, and anemia. 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

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

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

A Phase 3, Multicenter, Open-label, Randomized Study to Compare the Efficacy and Safety of MK-2870 Versus Treatment of Physicians Choice in 3L+ Advanced/Metastatic Gastroesophageal Adenocarcinoma, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma

Date Added
September 13th, 2024
PRO Number
Pro00137754
Researcher
Albert Lockhart

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 gastroesophageal adenocarcinoma that has progressed (become worse) after at least 2 prior treatments.

The goal is to determine the optimal dose level, safety, and tolerability for the study drug MK2870-015. This is a phase 3 study; MK2870-015 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, hair loss, weight loss, high blood sugar, and sore throat. 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 1/2, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Date Added
September 12th, 2024
PRO Number
Pro00136971
Researcher
Praneeth Baratam

List of Studies

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

This is a is a Phase 1, open-label, dose-escalation, and dose-expansion multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed Acute Myeloid Leukemias harboring alterations in KMT2A, NPM1, or NUP98 genes. The primary purpose of this study is to identify the maximum tolerated dose of SNDX-5613 (Revumenib) to be used in both a combination with intensive chemotherapy and alone. SNDX-5613 (Revumenib) is an "investigational" (not yet FDA approved) treatment. The study will enroll approximately 76 patients in 3 phases with each receiving cycles of chemotherapy followed by SNDX-5613 in the Induction and Consolidation phases followed by SNDX-5613 alone in the Maintenance Monotherapy phase if eligible. The study includes screening, treatment, safety follow-up, and survival follow-up periods over the course of 18 months. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit in participating in this study.

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



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