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 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

Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

Date Added
December 2nd, 2019
PRO Number
Pro00094604
Researcher
Theodore Gourdin

List of Studies

Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with bladder cancer. The purpose is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab,

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

A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus NKTR-214, Versus Nivolumab Alone Versus Standard of Care in Participants with Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible

Date Added
October 25th, 2019
PRO Number
Pro00088478
Researcher
Theodore Gourdin

List of Studies

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

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone, both before and after radical cystectomy versus standard of care in participants with muscle invasive bladder cancer (MIBC) who are cisplatin ineligible. The treatment will be given to participants, who have bladder cancer that has invaded into the bladder muscle, and who cannot receive a chemotherapy treatment called cisplatin. The standard treatment in this situation is to have surgery to remove the bladder (radical cystectomy). In this trial, one-third of patients will be assigned to have NKTR-214 and nivolumab before and after surgery, one-third will have nivolumab before and after surgery, and one-third will have surgery alone. NKTR-214 and nivolumab are treatments that boost the immune system to fight cancer. It is unknown if NKTR-214 and nivolumab or nivolumab alone will have an effect (good, bad, or no effect) on the participant or their cancer.

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

A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

Date Added
October 10th, 2019
PRO Number
Pro00092018
Researcher
Theodore Gourdin

List of Studies

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

Adult males are being asked to volunteer because they have been diagnosed to have bladder cancer that has spread and subjects tumor has a specific type of biomarker called PD-L1 (biomarkers can help to tell us what is going on in subjects body).This is a research study to find out if experimental medications called pembrolizumab and lenvatinib, when administered together. Participants can expect to be on this study for 2 years.

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

A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)

Date Added
September 26th, 2019
PRO Number
Pro00092663
Researcher
Theodore Gourdin

List of Studies

Keywords
Cancer/Genitourinary
Summary

This study is for patients with an advanced rare genitourinary cancer. The purpose is to test the good and bad effects of the drugs called cabozantinib, nivolumab and ipilimumab, when given in combination.

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

A PHASE II STUDY OF DOSE-DENSE GEMCITABINE PLUS CISPLATIN (DDGC) IN PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER WITH BLADDER PRESERVATION FOR THOSE PATIENTS WHOSE TUMORS HARBOR DELETERIOUS DNA DAMAGE RESPONSE (DDR) GENE ALTERATIONS

Date Added
September 18th, 2019
PRO Number
Pro00093086
Researcher
Theodore Gourdin

List of Studies

Keywords
Bladder, Cancer/Genitourinary
Summary

This study is for patients with invasive bladder cancer. The purpose of this study is to determine if a certain group of patients can avoid standard surgery called a radical cystectomy with pelvic lymph node dissection based on whether their tumor has a certain genetic marker and the stage of their cancer after finishing chemotherapy.

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

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Theodore Gourdin

List of Studies

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

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

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

A Dose-Escalation and Dose-Expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination with pembrolizumab and/or chemotherapy for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer

Date Added
December 12th, 2017
PRO Number
Pro00072223
Researcher
Theodore Gourdin

List of Studies

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

This is a study that will test how an experimental drug (enfortumab vedotin) combined with a kind of anticancer drug called an immune checkpoint inhibitor (CPI) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body.

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

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.

Date Added
January 10th, 2017
PRO Number
Pro00061532
Researcher
Theodore Gourdin

List of Studies

Keywords
Cancer/Genitourinary
Summary

This study will be conducted at MUSC and the VA on adult patients with newly diagnosed metastatic prostate cancer. The purpose of this study is to see if giving several cycles of docetaxel before androgen deprivation therapy (degarelix) improves outcomes, including survival rates, among men with metastatic prostate cancer. Patients will undergo screening assessments to see if they are eligible. Once on study, subjects will receive 6 cycles of docetaxel (cycle = 21 days). During cycle 4, subjects will begin taking degarelix every 28 days for up to 7 months.

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



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