A Phase 2 Trial of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer Save

Date Added
March 10th, 2020
PRO Number
Pro00095193
Researcher
Michael Lilly

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

This study is for patients who are 18 years and older that have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC).The investigational drugs in this study are Nivolumab and Ipilimumab.The purpose of this research study is to test the effectiveness (how well the drug works), safety, and tolerability of different dosing regimens containing nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel plus prednisone or prednisolone in participants with metastatic castration-resistant prostate cancer (mCRPC).Duration of this study will take approximately 24 months.

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

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial of DS-8201a, An Anti-HER2-Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HRpositive, HER2-Low Expressing, Unresectable and/or Metastatic Breast Cancer Subjects Save

Date Added
February 25th, 2020
PRO Number
Pro00090546
Researcher
Sara Giordano

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

You are being invited to take part in this research study, because you have a certain type of breast cancer called HER2 (Human Epidermal Growth Factor Receptor 2)-low expressing breast cancer that has spread and/or cannot be completely removed by surgery. The main purpose of this study is to gather information about an experimental drug, DS-8201 a, that may help to treat your disease, as well as, compare it to other standard or "comparator" treatments.

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

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia Save

Date Added
February 6th, 2020
PRO Number
Pro00094221
Researcher
Robert Stuart

List of Studies


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

This study is for subjects that are newly diagnosed with acute myeloid leukemia with FLT3 mutations. The investigation drug in this study is crenolanib. The purpose of this study is to compare the efficacy an investigational drug called crenolanib (also referred to as study drug in this consent) with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. The estimated average time that a subject will receive study drug on this study is about 12 months. The subject will take study drug as long as there is clinical benefit (that is their leukemia does not progress) and they are able to tolerate the study drug.

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

A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy alone versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post-Surgery Therapy with Nivolumab or Nivolumab and BMS-986205 in Participants with Muscle-Invasive Bladder Cancer Save

Date Added
February 5th, 2020
PRO Number
Pro00092528
Researcher
Theodore Gourdin

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

This study is for patient that have been diagnosed with muscle-invasive bladder cancer. The investigational drug in this study is Nivolumab and other chemotherapy treatments is given by intravenous (IV) infusion and the BMS-986205 is given in pill form.The purpose of this study is to test the effectiveness (how well the drug works), safety, and side effects of the experimental drug called BMS-986205, when BMS-986205 is added to another cancer medicine called nivolumab plus chemotherapy for subjects who have bladder cancer that has grown into the muscle wall of the bladder.

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

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL(EMERALD) Save

Date Added
January 30th, 2020
PRO Number
Pro00094418
Researcher
Antonio Giordano

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

Patients are being asked to take part in this research study because they have estrogen receptor positive (ER+), human epidermal growth factor negative (HER2-) advanced breast cancer. Researchers want to find out if an investigational drug called elacestrant, also known as RAD1901, can help people with their type of advanced breast cancer.

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

ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD) Save

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

A Phase 1b trial of CPX-351 Lower Intensity Therapy (LIT) plus Venetoclax as First Line Treatment for Subjects with AML who are Unfit for Intensive Chemotherapy Save

Date Added
January 14th, 2020
PRO Number
Pro00094444
Researcher
Robert Stuart

List of Studies


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

This study is for subjects with newly diagnosed Acute Myeloid Leukemia (AML). The investigational drug in this study is CPX-351(marketed as Vyxeos). The purpose of this research study is to find out whether a reduced dosing of CPX-351, given in combination with Venetoclax, is safe and effective when given to subjects with newly diagnosed AML who cannot tolerate intensive chemotherapy due to age or other health conditions. Subjects can expect to be in this study for approximately 1 year.

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

A Multicenter, Randomized, Controlled Phase 2 study: Efficacy And Safety Of I-131-1095 Radiotherapy In Combination With Enzalutamide In Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-Specific Membrane Antigen (PSMA)-Avid, Chemotherapy-na Save

Date Added
January 14th, 2020
PRO Number
Pro00094109
Researcher
Michael Lilly

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Sarcoma, Drug Studies, Men's Health
Summary

You are being invited to take part in this phase 2 clinical study because you have metastatic castration resistant prostate cancer and are planned for enzalutamide therapy. I-131-1095, an investigational drug, and 18F-DCFPyL, an investigational agent, meaning that they have not yet been approved for commercial use by the United States (US) Food and Drug Administration (FDA). In this study, you will first receive an injection of the first investigational agent, 18F-DCFPyL , which is to diagnostically see if your prostate cancer has high likelihood of benefiting from treatment from the second investigational study drug, I-131-1095 which is used for therapeutic therapy.

If so, I-131-1095 is received by IV together with enzalutamide, which is an oral drug. Enzalutamide is an FDA approved standard of care drug typically used in cancer treatments. People who take part in this study will either receive I-131-1095 radiation therapy together with enzalutamide, or enzalutamide alone. The duration of this study is approximately two years long.

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

A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma Save

Date Added
December 10th, 2019
PRO Number
Pro00095145
Researcher
Brian Hess

List of Studies

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

This study is for adult male and female subjects that have been diagnosed with a blood cancer called Hodgkin Lymphoma (HL) that has gotten worse or come back after treatment with available therapies known to provide clinical benefit. The investigational drug in this study is Camidanlumab Tesirine (Cami, ADCT-301) and will be administered intravenously. The purpose of this Phase 2 study is to evaluate the effectiveness and safety of the investigational drug Cami (ADCT-301) in subjects with HL that has gotten worse or come back after treatment. Participants can expect to be in this study for a total of 4 years; 1 year in treatment (Seen 4 times per month to begin with and then every 6-9 weeks at MUSC, while you remain on treatment) and 3 years in follow up.

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy Save

Date Added
December 9th, 2019
PRO Number
Pro00091697
Researcher
Paul O'brien

List of Studies

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

This study is for patients that have been diagnosed with differentiated thyroid cancer (DTC). The investigational drug used in this study is cabozantinib. The purpose of this study is to evaluate the effect of cabozantinib compared with a placebo in treating patients whose disease has progressed after receiving prior treatment with drugs that inhibit growth of tumor blood vessel (VEGFR-targeted therapy) for their thyroid cancer. Participants can expect to be on this study for about a year including 9 months of treatment, a follow-up visit 4 weeks after treatment and 3 months of follow up.

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

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