Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF 302)

Date Added
March 29th, 2022
PRO Number
Pro00116642
Researcher
Theodore Gourdin

List of Studies


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

The study is for patients that have been diagnosed with invasive urothelial carcinoma (cancer of the bladder [UBC] or cancer of the upper urinary tract [UTUC]), and had the cancer removed surgically. The investigational drug used in this study is infigratinib or placebo. The main purpose of this study is to to determine whether patients who have undergone surgery to remove invasive urothelial cancer that has a genetic abnormality (changes in tumor's DNA) in the Fibroblast Growth Factor Receptor 3 (FGFR3) gene who receive the investigational drug infigratinib for one year remain cancer free compared with those who recThe total length of time you will participate in the study depends on how you respond to the study drug and how long other participants remain in the study. After this study is completed, you will be offered to participate in a long-term follow up study. ive placebo for one year. Participants can expect to be in this study for up to 4 years.

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

A PHASE 1B/2 STUDY OF AVB-S6-500 IN COMBINATION WITH CABOZANTINIB, AVB-S6-500 IN COMBINATION WITH CABOZANTINIB AND NIVOLUMAB, AND AVB-S6-500 MONOTHERAPY IN PATIENTS WITH ADVANCED OR METASTATIC CLEAR CELL RENAL CELL CARCINOMA

Date Added
December 14th, 2021
PRO Number
Pro00114031
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Other, Drug Studies
Summary

The study is for subjects that have been diagnosed with Clear Cell Renal Cell Carcinoma (ccRCC) and have previously received front-line treatment. This study is testing an "investigational" (not yet FDA approved drug) study drug called AVB-S6-500. The primary purpose of this study is to evaluate the safety, tolerability and efficacy of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.. The subject may remain in the study for up to 24-months if they are tolerating and showing benefits from the treatment. AVB-S6-500 will be administered through IV. Cabozantinib will be administered in a pill form to be taken at home. Your study doctor will determine how many cycles of treatment you will receive based on your condition and standard of care. You will receive AVB-S6-500 (in Part 1 or if randomized to receive in Part 2) on days 1 and 15 of each subsequent cycle. There is no limit on the number of cycles a patient can receive.

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

PD-INHIBITOR (NIVOLUMAB) AND IPILIMUMAB FOLLOWED BY NIVOLUMAB VS. VEGF TKI CABOZANTINIB WITH NIVOLUMAB: A PHASE III TRIAL IN METASTATIC UNTREATED RENAL CELL CANCER [PDIGREE]

Date Added
November 17th, 2021
PRO Number
Pro00116463
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Kidney
Summary

This study is for patients with advanced kidney cancer and the purpose is to see if by adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong their life.

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

A Phase III Randomized Trial of Eribulin (NSC #707389) with or without Gemcitabine Versus Standard of Care (Physician's Choice) for Treatment of Metastatic Urothelial Carcinoma Refractory to, or Ineligible for, Anti PD1/PDL1 Therapy

Date Added
September 17th, 2021
PRO Number
Pro00114367
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Urinary
Summary

This study is for patients with urothelial bladder cancer that has spread to other parts of the body. The purpose is to see if patients can live longer if they are treated with a new drug alone, a new drug in combination with one of the usual chemotherapy drugs or the usual chemotherapy drugs by themselves.

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

A Phase II/III trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Date Added
August 27th, 2021
PRO Number
Pro00113791
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Urinary
Summary

This study is for patients with upper urinary tract cancer. The purpose of this study is to compare a usual treatment alone to using MEDI4736 (durvalumab) plus the usual treatment.

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

An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants with Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

Date Added
July 30th, 2020
PRO Number
Pro00097539
Researcher
Theodore Gourdin

List of Studies


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

This study is for a patient that have received previous treatment for renal cell carcinoma. During this study, patients will be randomized to get the investigational drug, MK-6482, or a standard of care drug, everolimus. This is a study to test if MK-6482 or the standard of care drug works better for patientsr type of prostate cancer. MK-6482 is considered experimental. "Experimental" means that the study drug is currently being tested for patientsr type of cancer. It has not been approved by certain health authorities, such as the United States (U.S.) Food and Drug Administration (FDA) to treat prostate cancer. Where as, everolimus, has been an approved standard of care chemotherapy by the FDA.
Participants can expect to be in this study for 4 years.

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 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 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



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