Synergistic Interplay of Systemic Lupus Erythematosus (SLE) and Hypertension (HTN)

Date Added
January 13th, 2023
PRO Number
Pro00122811
Researcher
Justin Van Beusecum

List of Studies

Keywords
Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Lupus, Women's Health
Summary

This study is to explore the relationship between lupus and hypertension (high blood pressure). Female volunteers between the ages of 18-65 are needed who meet 1 of 4 possible participation types: 1. Participants with diagnosis of lupus and hypertension, 2.Participants with lupus without hypertension, 3.Participants without lupus but have hypertension, or 4. Participants that have no lupus diagnosis or hypertension.

Study participation includes a 1 time visit to the Research Nexus and involves a review of currently available medical records and a brief participant questionnaire specific to demographics and behaviors. The study visit includes a series of 3 blood pressure readings and a blood collection of approximately 2 tablespoons of blood. Compensation is available.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu

PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


Keywords
Depression, Mental Health, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care mental health and substance use screening to look at treatment attendance and retention in treatment. Participation would involve completing the consent process and then the MUSC study team would collect mental health and substance use screening, referral and treatment data on participant's from their medical records or through the participant's pediatrician. The participant may also be asked to take part in surveys and interviews.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

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 2 Non-Randomized, Open-label, Multi-Cohort, Multi-Center Study Assessing the Clinical Benefit Of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Head and Neck Squamous Cell Carcinoma (HNSCC) (Pegasus Head and Neck 204)

Date Added
June 28th, 2022
PRO Number
Pro00118783
Researcher
John Kaczmar

List of Studies


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

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is SAR444245 (THOR-707). Investigational means the drug is not approved by the Food and Drug Administration (FDA).

The main purpose of this research study is to determine the antitumor activity of SAR444245 in combination with other approved anticancer therapies.

Participants will have blood draws, CT and/or MRI scans, and receive study drug in a vein (IV). There are risks to the study drug including fever, influenza-like illness, vomiting, nausea, and chills. It is possible that participant's symptoms will improve, but that cannot be guaranteed.

Screening will take up to 28 days. If participants receive treatment for the maximum amount of cycles, they will receive treatment for about 2 years. The end of treatment visit will be about a month after the last treatment is received. Then, participants will have in clinic observational visits every 3 months until disease progression, a new cancer therapy is started or 9 months from the date of first infusion of the last participant. Then, follow up visits by phone every 3 months for about 3 years. Total participation will last about 6 years.

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



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