Exploring the Unmet Care Needs of Women with Advanced Chronic Obstructive Lung Disease (COPD)

Date Added
September 21st, 2022
PRO Number
Pro00121659
Researcher
Jessica Madiraca

List of Studies

Keywords
COPD, Shortness of Breath, Women's Health
Summary

This study is for women who are diagnosed with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to explore the unmet care needs of women with advanced COPD. The study will provide insight into knowledge levels of COPD and palliative care, and finally, identify barriers to care in this population. Participation involves completing on-line surveys that take about 20 minutes to complete. Participants may choice to participate in an interview that will take approximately 30-45 minutes. Approximately 30 participants will take part in the study. We anticipate inviting a subset of up to fifteen participants to complete interviews.

Institution
MUSC
Recruitment Contact
Jessica Madiraca
856-339-1678
madiraca@musc.edu

A Phase 1B Dose Escalation Study Of Metabolically Fit CD19 Chimeric Antigen Receptor (CAR) T Cells With CD34 Selection Markers In Adult Patients With Relapsed Or Refractory CD19 B- Cell Non-Hodgkin Lymphoma And Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Date Added
August 16th, 2022
PRO Number
Pro00121846
Researcher
Brian Hess

List of Studies


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

This study is for adult male and female subjects that have been diagnosed with B-cell leukemias and lymphomas. In this research study, some of the subjects immune cells (called T cells) will be taken during a procedure called ‘apheresis', and genetically modified in the laboratory, in order to recognize a protein on the cancer cells. The investigational treatment in this study is called CD19-CD34t metabolically programmed CAR-T cells. The purpose of this study is to test whether these genetically CD19-CD34 CAR T-cells when re-introduced back into the body, will be able to safely and effectively attack the cancer cells. The investigators also want to determine the dose of genetically modified CD19-CD34 CAR T-cells which can be safely administered to subjects. Subjects can expect to be in this study for up to 15 years.

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

Prospective ctDNA Monitoring in Exceptional Responders to Immunotherapy: A Pilot Study

Date Added
August 8th, 2022
PRO Number
Pro00117604
Researcher
John Kaczmar

List of Studies


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

This study is for subjects that have been diagnosed with advanced cancer. The purpose of this study is to find subjects with advanced cancer that had an exceptional disease response (improvement) while being treated with standard immunotherapy agents. This study will monitor their progression through a series of blood draws. Subjects will either continue immunotherapy or have completed immunotherapy. Participation in the study will take about 6 visits over a period of about 2 years. During this time the study team will follow your care by clinic visit, phone contact and/or medical record review every three months to collect information on the status of your cancer. This is not a treatment study.

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

A Phase II Open-Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy

Date Added
July 26th, 2022
PRO Number
Pro00118909
Researcher
Theodore Gourdin

List of Studies


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

This study is for subjects that have metastatic urothelial cancer (mUC). Metastatic means your cancer has spread outside the area where it started and has spread to distant parts or organs of the body. This study is testing an "investigational" (not yet Food and Drug Administration, FDA, approved drug) study drug called sacituzumab govitecan. Sacituzumab govitecan is given intravenously, through IV. The primary purpose of this study is to evaluate treatment with sacituzumab govitecan alone and in combination with other treatments namely cisplatin, avelumab and pembrolizumab improves tumor shrinkage. They are antibodies made in a laboratory that blocks signals that the cancer sends to quiet your immune system. By blocking that signal your immune system can see the cancer as foreign and fight it. The subject may remain in the study for 18 months. They may receive additional treatment beyond 18 months if they are tolerating and showing benefit form the treatment.

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

A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)

Date Added
June 1st, 2022
PRO Number
Pro00116818
Researcher
Daniel Reuben

List of Studies


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

This study is for patients that have been diagnosed with stage III-IV Melanoma after a complete resection (no evidence of disease). The investigational drug in this study is relatlimab in combination with nivolumab. Investigational means the drug is not approved by the United States Food and Drug Administration (US FDA). Participants will be assigned to receive relatlimab with nivolumab in a fixed dose combination (FDC, both drugs in a single vial) or nivolumab alone, administered by intravenous (IV) infusion, meaning the drug is a solution given through a vein. The infusion is planned to take 30 minutes. Neither the participants or study doctor will know what is being administered.

This study is designed to explore if treating stage III-IV resectable melanoma patients with this combination, after they have surgery to remove all tumors, will reduce the probability of having progressive disease when compared to nivolumab alone, as well as to assess the possible side effects that this combination therapy might have. Participants can expect to be on this study for a minimum of 6 years.

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

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Date Added
May 11th, 2022
PRO Number
Pro00117937
Researcher
Paul O'Brien

List of Studies


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

This study is for participants that have colorectal cancer that has been treated before, spread to other parts of the body and they test positive for a protein called PD-L1. PD-L1 is a protein that helps keep T cells from killing other cells, including cancer cells. This study drug (MK-4280A) is used to block this protein so the "brakes" on the immune system are released and the ability of T cells to kill cancer cells is increased. MK-4280A is a mixture of 2 drugs: MK-4280 (favezelimab) and MK-3475 (pembrolizumab also called pembro). MK-4280A has not been approved by the United States Food and Drug Administration (FDA). This purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) and to compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). Participants will be randomized to one of two groups. Group 1 will get MK-4280A and Group 2 will get a standard treatment. This study has 3 phases: Screeing (about 1 month), Treatment (depends on which drug the participant gets, how well their cancer is controlled, and how they are feeling) and Follow-up (1 visit 30 days after the last dose of study drug, then every 9 weeks, then the study team will contact you every 12 weeks). Participants may experience certain side effects and discomforts from taking the study drug. Because the study drug is experimental, all the side effects may not be known.

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

A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

Date Added
May 10th, 2022
PRO Number
Pro00119953
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Prostate, Women's Health
Summary

This study is for patients that have already received standard treatments for their cancer and their cancer has gotten worse or returned after their last treatment. The purpose of this study is to learn about the effects of the study drug XL092 when given alone, in combination with atezolizumab, and in combination with avelumab by testing its safety, the ability of your body to accept the drug(s), to measure the drug(s) and/or its break-down products levels in your blood, and how your body reacts to the drug(s). This research study will be the first time XL092 alone or in combination with atezolizumab will be given to people. The study drugs in this research have not been approved by the United States Food and Drug Administration (FDA). There are two parts in this study, a Dose Escalation part and a Cohort Expansion part. The first part of the study was the Dose Escalation phase, when different participants were given different doses of the study drug until the safest, most effective dose was found; this part of the study has been completed. The study is now enrolling to the Cohort Expansion part of this study, where the dose that has been determined to be safe will be given to more participants with different types of cancer. The Dose Escalation part of this study has stopped and the safe dose has been found. This study is now enrolling to the Cohort Expansion part of this study, where the safe dose of the study drug found in the Dose Escalation part will be given to more participants with different types of cancer. Participants will either be assigned to the treatment group that will receive XL092 alone or the treatment group that XL092 in combination with atezolizumab. Which treatment group they are assigned depends on the type of cancer they have. TXL092 is in tablet form taken by mouth. Avelumab will be given as an intravenous (IV) infusion once every 2 weeks at the study site. Atezolizumab will be given as an intravenous (IV) infusion once every 3 weeks at the study site. Total study duration is expected to be about 6 months but participants could be in the study for up to 2 years.

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

An Open-Label, Multicenter, Phase 2 Study of CLR 131 in Patients with Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients with Waldenstrom Macroglobulinemia (CLOVER-WaM)

Date Added
April 26th, 2022
PRO Number
Pro00118851
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with multiple myeloma or lymphoma that has returned after standard therapy or that are not able to tolerate the standard therapy. This study is testing an "investigational" (not yet Food and Drug Administration (FDA) approved) radioactive study drug called CLR 131. This study will find out if the drug is safe and tolerable. The subject will be given the study drug on days 1, 15, 57, and day 71 of the study. At any given visit, the subject may undergo procedures, such as a physical exam, heart monitoring, blood draws, and an ECG (electrocardiogram). The subject may remain in the study for up to approximately 5 to 8 months.

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

RADIANCE TRIO Continued Access Protocol (TRIO CAP) A study of the ReCor Medical Paradise System in Clinical Hypertension

Date Added
April 26th, 2022
PRO Number
Pro00118326
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Men's Health, Women's Health
Summary

The purpose of this study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the US Food and Drug Administration (FDA). Renal denervation is a procedure where a catheter is placed inside the blood vessels (renal arteries) that go to the kidneys. Ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels. This is a continued access protocol meaning studies have already been done using this device.

This study is for participants who take 3 or more high blood pressure medications but continue to have high blood pressure. This is a five year study consisting of in person visits at screening, baseline, pre procedure testing, procedure and visits at 1,2,3,4,5,6,12,24,36,48 and 60 months. Study related testing includes BP measurements including 24 hour blood pressure readings, electrocardiograms (ECG), blood work, urine studies, and CT scans. Risks associated with this study include procedure risks such as pain, bleeding or bruising at the catheter insertion site. There are other study related risks such as risks of blood draws, radiation risk associated with the CT scan and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

A Phase Ib Trial of Zanubrutinib in Combination with R-CHOP (ZaRCHOP) for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Date Added
April 26th, 2022
PRO Number
Pro00119556
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 newly diagnosed with diffuse large B cell lymphoma (DLBCL). This study is testing an "investigational" (not yet approved by the Food and Drug Administration (FDA)) combination of the drug zanubrutinib (BRUKINSAâ„¢) and a standard chemotherapy treatment called R-CHOP. This study will test the how well the drug combination works and how safe it is. The subject will be given the study drug combination in 21 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, bone marrow biopsies, and imaging scans. The subject may remain in the study for up to approximately 2 years.

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



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