A Phase 3 Open-Label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared with Investigators Choice Monotherapy Treatment in Previously Treated Patients with Incurable, Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma

Date Added
December 10th, 2024
PRO Number
Pro00138267
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about the effects of Petosemtamab, an investigational drug not FDA approved, compared to standard of care treatment for people with head and neck cancer that has been previously treated with immunotherapy and chemotherapy. 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 receiving petosemtamab or one of the three standard of care choices. In the follow up period the side effects after completion of petosemtamab administration or assigned standard of care treatment will be evaluated. Also, approximately every 12 weeks after study treatment stopped, either petosemtamab or assigned standard of care, participants will receive a phone call for long term follow-up for up to 1.5 years. Participation in this study may last up to two years. The participants will complete questionnaires to evaluate the differences in the quality of life for participants that received petosemtamab versus standard of care treatment. Some serious risk related to this study are infusion related reactions, rash and diarrhea. 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 Petosemtamab 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 1, Randomized, Double-Blind, Placebo-Controlled, Single Oral Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMN 349 in PiZZ and PiMZ/MASH Adult Participants

Date Added
December 10th, 2024
PRO Number
Pro00141286
Researcher
Charlie Strange

List of Studies


Keywords
Drug Studies, Genetics, Liver, Rare Diseases
Summary

Alpha-1 antitrypsin (AAT) deficiency is a condition in which the body does not make enough of AAT, a protein that protects the lungs and liver from damage. This condition is inherited, meaning you get the faulty gene from one or both of your parents.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral administration of BMN 349 in adult participants with the PiZZ genotype (also defined as having a severe deficiency or AAT ≤ 60mg/dL) or PiMZ genotype with metabolic dysfunction-associated steatohepatitis (MASH). Participants will receive an oral single dose of BMN 349 (250 mg), a medication designed to assist Z-alpha-1 antitrypsin to get out of the liver cell. The study drug BMN 349 has not been approved by the Federal Drug Administration (FDA).

This is a phase 1 study in which participants will get a single pill dose of drug or placebo to measure the amount of alpha-1 that gets out of the liver cells and into the bloodstream. Study details include:
• Study duration: up to 78 days
• Treatment duration: 1 day (single dose).
• Observations: The study will collect data on medical history, physical examination, vital signs, electrocardiogram readings, clinical laboratory parameters, pulmonary function tests, and drug distribution.
• Visit frequency: The Screening Visit, dosing, and post dosing evaluations will be conducted at MUSC on 3 consecutive days. Visits at days 8 and 36 days will occur at study site. Other procedures/assessments may be performed at the study site or at home by a healthcare professional and/or by telemedicine.

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

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults with Selected Advanced Solid Tumors

Date Added
December 6th, 2024
PRO Number
Pro00138422
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer, Drug Studies
Summary

This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-5125 in adult participants with locally advanced or metastatic selected solid tumors.

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

Refining Tamoxifen Dose for Premenopausal Breast Cancer Prevention (RENAISSANCE): A Phase II Single Arm Trial

Date Added
November 21st, 2024
PRO Number
Pro00137081
Researcher
Kevin Hughes

List of Studies

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

This study is for subjects that are premenopausal and have a higher-than-average risk of developing breast cancer. The main purpose of this study is to determine if using change in breast density to guide personalized tamoxifen dosing is better or worse than the usual approach for premenopausal women with dense breast tissue at higher-than-average risk of developing breast cancer. Subjects can expect to be in this study for up to XX months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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 3, Randomized Study of CG0070 versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor

Date Added
November 7th, 2024
PRO Number
Pro00137188
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

The study is for patients that have been diagnosed with bladder cancer. Cretostimogene Grenadenorepvec is the study drug that is being utilized. The primary purpose is to evaluate the recurrence free survival (RFS) of transurethral resection of bladder tumor (TURBT) followed by cretostimogene versus TURBT followed by observation in participants with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC). The subject may remain in the study for up to 24 months. They may receive additional treatment beyond 24 months if they are tolerating and showing benefit from the treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincial-trials@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
Katherine Antel

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

Impacts of drug abuse-mediated inflammatory perturbations on affinity maturation of anti-CD4 autoantibodies and poor immune reconstitution from ART in HIV

Date Added
November 6th, 2024
PRO Number
Pro00140552
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

This study is to understand HIV-infected cocaine users have poor immunity after anti-HIV treatment, but HIV-infected cannabis users are likely different. Cocaine use always is associated high inflammation and cannabis use is associated with low inflammation. We study how inflammation cannot be controlled in cocaine users; our goal is to develop new therapies to help cocaine users to have a better health and immunity.

Institution
MUSC
Recruitment Contact
Wei Jiang
8438762457
jianw@musc.edu

Phase 3 Randomized Open-label Study of Adjuvant Pembrolizumab W/WO MK2870 in Resectable Stages II-IIIB(N2) NSCLC for Patients not AchievingpCR After Receiving Neoadjuvant Pembrolizumab with Platinum-Based Doublet Chemotherapy Followed by Surgery

Date Added
October 31st, 2024
PRO Number
Pro00138712
Researcher
Mariam Alexander

List of Studies

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

This research study is testing a new treatment plan for patients with a type of lung cancer that can be surgically removed. The study focuses on patients who have not had complete success with initial treatments before surgery. The treatment plan includes a combination of chemotherapy and a drug called pembrolizumab before surgery, followed by surgery to remove the cancer, and then more pembrolizumab with or without another drug called MK-2870 after surgery.

The goal is to see if adding MK-2870 can help improve the chances of recovery and prevent the cancer from coming back in patients who didn't respond fully to the initial treatment. This study aims to find better ways to treat lung cancer and improve the survival rates of these patients.

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



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