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

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

List of Studies

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

Date Added
February 25th, 2020
PRO Number
Pro00090546
Researcher
Frank Brescia

List of Studies

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

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

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

List of Studies

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

A PHASE II EVALUATION OF BENDAMUSTINE, OBINUTUZUMAB AND VENETOCLAX IN PATIENTS WITH UNTREATED MANTLE CELL LYMPHOMA

Date Added
January 28th, 2020
PRO Number
Pro00095207
Researcher
Irl Greenwell

List of Studies

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

This study is for adult male and females that have been diagnosed with mantle cell lymphoma. The drugs in this study include the combination of bendamustine, obinutuzumab and venetoclax (also called "BOV"). They are each approved for treatment, but is considered investigational (not approved by the FDA), when combined. The purpose of this study is to find out if BOV is effective and safe for the treatment of people with mantle cell lymphoma. Participants can expect to be in this study for approximately 51/2 years.

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

A Multicenter, Randomized, Double-Blinded, Controlled Phase 3 Trial of Cabozantinib in Combination with Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Combination with Matched Placebo in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (RCC) of IMDC Intermediate or Poor Risk

Date Added
December 16th, 2019
PRO Number
Pro00091797
Researcher
Theodore Gourdin

List of Studies

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

This clinical research study is with patients who have kidney cancer (renal cell carcinoma or RCC) that has advanced or spread to other areas of the body. the study drugs are cabozantinib (XL184) in combination with nivolumab plus ipilimumab, or placebo in combination with nivolumab plus ipilimumab. this study will last about 15-21 months.

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

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

List of Studies

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

Clinical Protocol for the Investigation of the ProSpace™ Balloon System

Date Added
November 26th, 2019
PRO Number
Pro00094196
Researcher
David Marshall

List of Studies

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

The ProSpace balloon is being studied to test if it will temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating that space will reduce the radiation dose delivered to the anterior rectum. The ProSpace balloon is composed of a bioresorbable polymer material called RESOMER. RESOMER is well studied and approved for many indications. This study will show if it will maintain that space for the entire course of prostate radiotherapy treatment and then be completely absorbed by the body over time. The balloon is considered a permanent implant because it will remain in the body for at least 30 days. The ProSpace System study will collect data to demonstrate the safety and efficacy of its indication. This device is currently investigational in the United States

Institution
MUSC
Recruitment Contact
Sarah Mulhern
843-792-9321
hcc-clinical-trials@musc.edu

A phase 2, multicenter, single-arm study of retreatment with brentuximab vedotin in subjects with relapsed or refractory classic Hodgkin lymphoma (cHL) or CD30-expressing peripheral T cell lymphoma (PTCL)

Date Added
November 26th, 2019
PRO Number
Pro00092170
Researcher
Irl Greenwell

List of Studies

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 classical Hodgkin lymphoma (cHL) or peripheral T cell lymphoma (PTCL). The investigational drug in this study is Brentuximab vedotin. The purpose of this study is to test if brentuximab vedotin works to treat cHL and PTCL in people who already got brentuximab vedotin. Participants in this study will visit MUSC at least every 21 days and will continue to be followed every 4 months, until the study is closed.

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

Randomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double-Hit and Double Expressing Lymphomas

Date Added
November 18th, 2019
PRO Number
Pro00094317
Researcher
Brian Hess

List of Studies

Keywords
Cancer, Cancer/Lymphoma
Summary

This study is for patients that have been diagnosed with double-hit or double expressing lymphoma. The investigational drug in this study is venetoclax. The purpose of this study is T\to compare the progression-free survival (PFS) of R-chemotherapy plus venetoclax versus Rchemotherapy alone in MYC/BCL2 double-hit and double expressing lymphomas. Participants can expect to receive treatment for up to 18 weeks and followed by the study doctor for up to 10 years after being registered to the study.

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

Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)

Date Added
October 22nd, 2019
PRO Number
Pro00088996
Researcher
Brian Hess

List of Studies

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

This study is for patients who have been diagnosed with relapsed (the disease has gotten worse after a period of improvement) or refractory (the disease does not respond to treatment) aggressive B-cell non-Hodgkin lymphoma .The investigational therapy in this study is tisagenlecleucel treatment. This treatment includes collecting T cells from patient's blood and changing them by gene transfer to make them recognize tumor cells. The purpose of this study is to see how well tisagenlecleucel therapy treats the disease and how safe the treatment is when compared to Standard or Care treatment. Participants can expect to be in this study for up to 60 months and in follow up for up to 15 years.

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



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