A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)

Date Added
April 2nd, 2024
PRO Number
Pro00134426
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.

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

Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck

Date Added
March 25th, 2024
PRO Number
Pro00134487
Researcher
Bhishamjit Chera

List of Studies

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

This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.

Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.

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

Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Date Added
March 5th, 2024
PRO Number
Pro00134455
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. Patients are expected to be in the study for XXmonths.

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

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physicians Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Date Added
March 1st, 2024
PRO Number
Pro00134328
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

The study is for patients that have been diagnosed with TNBC (Triple Negative Breast Cancer). The treatment drugs being utilized are sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda). The main purpose of this study is to determine if the combination of sacituzumab govitecan and pembrolizumab can improve outcomes and delay the return of disease in subjects with high-risk early TNBC. Subjects can expect to be in this study for up to 18 months.

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

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Date Added
February 23rd, 2024
PRO Number
Pro00133321
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

Keywords
Autoimmune disease, Drug Studies, Inflammation, Rare Diseases
Summary

The purpose of this study is to test whether a drug called NS-229 (the study drug) is a potential treatment for patients with Eosinophilic Granulomatosis With Polyangiitis (EGPA).

NS-229 is an investigational drug that is provided in an oral pill form. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, NS-229 will be compared with a placebo (dummy drug), having no active drug in it. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is also double-blinded study, meaning you and your study doctor will not know what you are receiving, the NS-229 or placebo.

The study is sponsored by a NS Pharma, Inc. Participation in the study will require 12 visits to the MUSC main campus over approximately 8 months. Visits are much like the your standard of care and include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), tests to assess your lung function and health (Pulmonary Function Test (PFT) and spirometry, health questionnaires. You will also be asked to complete a daily diary regarding your medication use and vasculitis symptoms.

Compensation is available for participation

Institution
MUSC
Recruitment Contact
Kathleen Maksimowicz-McKinnon
843-792-0066
maksimow@musc.edu

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

Date Added
February 14th, 2024
PRO Number
Pro00135002
Researcher
Susan Sonne

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This study is designed to evaluate the safety and effectiveness of using a combination of two different medications (extended release naltrexone and bupropion) compared to matching placebo (an inactive substance) in the treatment of methamphetamine use disorder. Participants will undergo screening, and if eligible, will receive study medications along with brief medication management for twelve weeks, with follow up visits at weeks 14 and 16. The total study duration is around 19 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
864.898.2992
chapmanb@musc.edu

A Pilot, Open-label Study to Evaluate the Safety and Efficacy of ARINA-1 in Adult Participants with Chronic Bronchitis (CB)

Date Added
February 13th, 2024
PRO Number
Pro00133594
Researcher
Charlie Strange

List of Studies


Keywords
COPD, Drug Studies, Lung, Pulmonary
Summary

The study seeks to evaluate the effectiveness of ARINA-1, an investigational inhaled medication, in reducing cough and mucus production in patients who are diagnosed with chronic bronchitis. If enrolled in this study, there will be four clinic visits, one telehealth visit, and one phone call. As part of the study assessments, a cough monitor will be worn on the wrist, as well as repeat spirometry, questionnaires, and bloodwork will be completed. The ARINA-1 will administered with a nebulizer provided to participants and is taken twice daily for 28 days. The total duration of this study is up to 12 weeks for each enrolled participant.

Compensation will be provided for your time for each visit that is completed.

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

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Date Added
February 13th, 2024
PRO Number
Pro00134508
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling subjects with non-obstructive hypertrophic cardiomyopathy (nHCM). nHCM is typically a genetic condition in which the main pumping chamber of the heart (called the left ventricle) becomes abnormally thickened and stiff, which makes it harder for the ventricle to fill and pump out enough blood. This study involves the investigational medication Aficamten, which means it is not approved for commercial use by the Food and Drug Administration. (FDA) Aficamten is designed to reduced excessive heart pumping function. This is a randomized study which means all subjects are assigned to receive either Aficamten or placebo. Subjects have a 50:50 chance of being assigned to either group, but will not know which group they are assigned. Placebo looks like the medication but does not have any active ingredients in it. Study procedures include exercise testing, echocardiograms (ultrasound test of the heart), blood work, questionnaires and genetic testing. Study risks include risks associated with the study medication including decreased heart pumping, nausea, headache and dizziness. There are also study procedure related risks, and the risk of loss of confidentiality. There may be no benefit but the information learned may benefit others in the future. Study participation will last between 10.5 and 19 months and include up to 13 visits to the study site. Visits will generally last 2-3 hours.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels

Date Added
January 23rd, 2024
PRO Number
Pro00131570
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.

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

A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime/GOG-3076 Study)

Date Added
January 4th, 2024
PRO Number
Pro00132648
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.

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



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