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

Feasibility of a Cannabis Study in Peripartum Women

Date Added
April 19th, 2022
PRO Number
Pro00119473
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Non-interventional, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The purpose of the study is to 1) determine the most practical study recruitment strategies for pregnant and postpartum women with marijuana use and 2) collect data to determine what types of studies pregnant and postpartum women are willing to take part in. Participation involves completing an online survey that takes about 10 minutes to complete.

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

Exploratory clinical trial of topical Imiquimod 5% cream as window-of-opportunity monotherapy for early-stage oral cancer

Date Added
March 15th, 2022
PRO Number
Pro00119074
Researcher
Angela Yoon

List of Studies

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

This study is for subjects that have been diagnosed with oral cancer. The investigational drug in this study is Imiquimod. The purpose of this research study is to find out what effects, good and/or bad, topical application of the study drug Imiquimod will have on you and your oral cancer. Subjects can expect to be in this study for up to 1 month.

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

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC (Tec-Dara) versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants with Relapsed or Refractory Multiple Myeloma

Date Added
February 23rd, 2022
PRO Number
Pro00116243
Researcher
Hamza Hashmi

List of Studies

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

This study is for subjects with multiple myeloma who have not responded to their most recent treatment. The study is testing an "investigational" (not yet FDA approved drug) study drug called Teclistamab. The primary purpose of this study is to see how teclistamab in combination with daratumumab (Tec-Dara) compares to either daratumumab, pomalidomide, and dexamethasone (DPd) or daratumumab, bortezomib (VELCADE), and dexamethasone (DVd) for treating participants with multiple myeloma who have not responded to their most recent treatment. The study will last for approximately 6 years, but subjects at MUSC can expect to be in the study for approximately 1 and a half years. The duration of the subject's participation will depend on how you respond to the study treatment.

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

Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Date Added
February 16th, 2022
PRO Number
Pro00115036
Researcher
Gilbert Bader

List of Studies

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

This study is for subjects that have been diagnosed with HR+, HER2-negative breast cancer while still being in a premenopausal hormone status (i.e. females with active ovaries that produce hormones that cause menstrual cycles (even if they are not regular). The investigational drug that will be used is TOL2506. The drug will be given as an injection. The study is to assess suppression of ovarian function
following administration of TOL2506 in premenopausal subjects with HR+, HER2-negative breast cancer. Participants can expect to be in this study for 24 months.

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

Phase 3 trial using the SYK inhibitor, entospletinib, in combination with standard induction and consolidation chemotherapy in newly diagnosed, NPM1-mutated Acute Myelogenous Leukemia

Date Added
February 2nd, 2022
PRO Number
Pro00116455
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects who have been recently diagnosed with AML that is caused by an abnormality in a gene (also called a mutation) called nucleophosmin-1 (NPM-1). The study is testing an "investigational" (not yet FDA approved drug) study drug called Entospletinib. The primary purpose of this study is to to see if a test drug not yet approved (in other words, investigational or not available by prescription), named Entospletinib, can improve the outcome of treatment (in other words, is more effective) in certain people with AML when it is combined with chemotherapy compared with chemotherapy alone, and can be given safely when combined with chemotherapy. MUSC subjects can expect to be in the study for up to approximately 5 years.

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

A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors

Date Added
January 24th, 2022
PRO Number
Pro00113662
Researcher
Brian Orr

List of Studies

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

This study is for participants that have a solid tumor(s) considered a cancer that has worsened or returned after standard treatment, and for which no other standard cancer treatment is available. The purpose of this study is to learn how well a study drug called NM21-1480 is tolerated in patients with solid tumors such as yours. The purpose is also to determine if it causes any side effects, as well as to determine the highest tolerated dose of NM21-1480. NM21-1480 is an investigational (experimental) study drug.

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

Unbiased Discovery and Validation of Serum Auto-Antibodies in Patients with Rheumatic Immune-Related Adverse Events Due to Immune Checkpoint Inhibitors

Date Added
January 18th, 2022
PRO Number
Pro00117791
Researcher
John Wrangle

List of Studies


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

This study is for subjects that have been diagnosed with cancer, as well as healthy research subjects. The purpose of this study is to evaluate the risk factors for development of immune related adverse side effects from cancer immunotherapy and to evaluate differences from healthy research subjects. Participation in the study will take about 2 visits over a period of 6 months.

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

A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination with AMG 404 in Subjects with Small Cell Lung Cancer (SCLC)

Date Added
January 11th, 2022
PRO Number
Pro00115977
Researcher
Mariam Alexander

List of Studies

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

This study is for patients who have been diagnosed with small cell lung cancer (SCLC). The investigational drugs in the study are AMG 757 and AMG 404. Both drugs are immunotherapy treatments, medicines that work with your immune system to help fight cancer. AMG 757 and AMG 404 will be given together in a liquid form directly into participants' veins (intravenously). This study is being done to find out about the safety and efficacy (effects good or bad) of AMG 757 in combination with AMG 404 for the treatment of SCLC. Participants can expect to receive treatment for about 12 months. The duration of AMG 757 and AMG 404 treatment will depend on how the disease responds to the investigational drugs and how the body tolerates AMG 757 and AMG 404. So, participation may be longer or shorter than this window. The study period includes screening period lasting up to 21 days, a treatment period, a first safety follow-up visit, and a second safety follow-up visit. This will be followed by long-term follow-up visits up to 1 year from the first dose of AMG 757 for a total of about 2 years in the study.

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

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Date Added
January 11th, 2022
PRO Number
Pro00117607
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects that have been diagnosed with AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome). This study is testing an "investigational" (not yet FDA approved) study drug called Sea-CD70. This study will find out if the drug is safe and tolerable, and find out the maximum tolerated dose (highest dose of a drug or treatment that does not cause unacceptable side effects) or recommended dose for the next phase of clinical study. The subject will be given the study drug in 28 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, ECG (electrocardiogram), or a bone marrow exam. The subject may remain in the study for up to approximately 3 years.

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



-- OR --