Randomized Phase III Study of Mosunetuzumab vs. Rituximab for low Tumor Burden Follicular Lymphoma

Date Added
March 6th, 2025
PRO Number
Pro00142136
Researcher
Brian Hess

List of Studies


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

This study is for subjects diagnosed with follicular lymphoma. The purpose of this study is to assess if treatment with Mosunetuzumab can improve long term remission in patients with low tumor burden follicular lymphoma compared to rituximab. The treatment period for the Rituximab arm is approximately 40 weeks. The treatment period for the Mosunetuzumab arm is approximately 24 weeks. However the subject may remain in the study for up to 10 years for the follow-up period.

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

A Phase 3, Randomized, Open-label, Active-Comparator-Controlled Clinical Study to Evaluate the Safety and Efficacy of Bomedemstat (MK‑3543/IMG-7289) versus Best Available Therapy (BAT) in Participants With Essential Thrombocythemia who have an Inadequate Response to or are Intolerant of Hydroxyurea.

Date Added
February 18th, 2025
PRO Number
Pro00141947
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have Essential Thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. This study will measure the safety and effectiveness of an inhibitor treatment called bomedemstat. Bomedemstat is an "investigational" (not yet FDA approved) treatment. The main purpose of the study is to how bomedemstat compares to BAT (best available therapy) as an effective treatment for ET. The study will enroll approximately 300 patients who will be randomly assigned 1:1 (like flipping a coin) to either bomedemstat or BAT. The study includes a screening phase, initial treatment phase, extended treatment phase, and posttreatment phase. The initial treatment portion of the study begins on study Day 1 and continues until the participant completes treatment at Week 52. The primary endpoint analysis will be performed on data from the first 52 weeks of treatment. Patients who have not discontinued study treatment at Week 52 will be eligible to continue receiving study treatment in the Extended Treatment Phase for up to Week 156. Patients in the BAT arm who have received a minimum of 52 weeks of treatment and discontinued study treatment due to intolerance/resistance/refractoriness/inadequate response (defined by the investigator as per the local product labels of BAT regimens) may be eligible to switch to the bomedemstat arm during the Extended Treatment Phase at the investigator's discretion (as per protocol defined eligibility to receive bomedemstat). Patients will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

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

A Phase IB and Randomized Phase II trial of Megestrol Acetate with or without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Date Added
February 12th, 2025
PRO Number
Pro00142481
Researcher
Brian Orr

List of Studies

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

This study is for patients who have been diagnosed with grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer. The investigational drug used in this study is ipatasertib. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The marketed drug used in this study is megestrol acetate (MA). Marketed means the drug has been approved by the FDA for sale and use in the United States. The primary purpose of this study is to compare the progression free survival of the combination of ipatasertib with MA to MA alone among women with metastatic grade 1-2 recurrent or metastatic endometrioid endometrial cancer. Patients will be randomized to either of the two treatments. Randomization is like flipping a coin, essentially meaning that each option has an equal likelihood of being selected. The drug is given to participants orally. Participants can expect to be on this study until disease progression or adverse events prohibit further therapy.

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

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Date Added
December 18th, 2024
PRO Number
Pro00141575
Researcher
John Kaczmar

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 recurrent or metastatic PD-L1-positive, HPV-negative head and neck squamous cell carcinoma without prior treatment. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BCA101. This is a phase 2 study; BCA101 is not FDA approved by the U.S. Food and Drug Administration (FDA). Treatment for this study may be up to 5 years. The procedures include taking study drug intravenously, blood and urine samples, and CT scans. Risks include diarrhea, nausea, vomiting, mouth sore, nose bleed, headache, and skin rash. 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 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 7 and 35 days will occur. 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



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