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 Save

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

List of Studies

Silhouette
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) Save

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

List of Studies

Silhouette
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

An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies Save

Date Added
October 4th, 2019
PRO Number
Pro00086345
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer
Summary

This clinical study includes two phases, a "treatment phase" (i.e. phase during which subjects receive avelumab) and a "long-term follow up phase" (i.e. phase during which subjects are followed after stopping avelumab), which is the phase you are in. The purpose of the "long-term follow up phase" is to see if treatment with avelumab is safe and well tolerated, and how well the treatment worked in subjects like you who have been treated with avelumab in the past. This "long-term follow-up" portion may continue until a maximum of 5 years after the last participant in the clinical study receives the last dose of avelumab.

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) Save

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

List of Studies

Silhouette
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 Save

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

List of Studies

Silhouette
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 Save

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

List of Studies

Silhouette
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

PHASE III RANDOMIZED ADJUVANT STUDY OF MK-3475 (PEMBROLIZUMAB) IN MUSCLE INVASIVE AND LOCALLY ADVANCED UROTHELIAL CARCINOMA (AMBASSADOR) VERSUS OBSERVATION Save

Date Added
December 20th, 2017
PRO Number
Pro00072454
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer/Genitourinary
Summary

This study is for men and women who have had surgery to remove bladder cancer which is in the deep muscle of the bladder wall. The purpose of this study is to compare any good and bad effects of using a drug called MK-3475 (pembrolizumab) after the removal of your muscle invasive bladder cancer.

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

A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-ONcology Study in Participants with Advanced Renal Cell Carcinoma (FRACTION-RCC) Save

Date Added
December 12th, 2017
PRO Number
Pro00070527
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney
Summary

The purpose of this study is to determine whether nivolumab in combination with other therapies is more effective than nivolumab in combination with ipilimumab in treating patients/subjects with advanced renal cell carcinoma.

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 Save

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

List of Studies

Silhouette
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

Phase I Study of C6 Ceramide NanoLiposome in Patients with Advanced Solid Tumors Save

Date Added
February 21st, 2017
PRO Number
Pro00063038
Researcher
Theodore Gourdin

List of Studies

Silhouette
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to study the safety and efficacy of the investigational drug, C6 Ceramide NanoLiposome (CNL). Investigational means that it is not approved by the U.S. Food and Drug Administration (FDA). Study subjects are being asked to participate in this study because they have been diagnosed with an advanced solid tumors and their cancer has not responded to standard treatment. Treatment with the study drug has been shown in animal studies to slow the growth of cancers. These effects may result from cancer cell death or inhibition of tumor blood vessel formation triggered directly by the study drug. An investigational new drug application has been filed at US Food and Drug Administration (FDA) and the FDA has allowed the use of the study drug in this study.

The study team will learn how the drug is handled in the subject's body by measuring the levels of the drug in your blood. They study team will also learn if the treatment is slowing or stopping the growth of the subject's tumor. This is the first time study drug will be given to humans.

This is a dose escalation study which means patients who take part in this study will be treated with different doses of the study drug. Each new dose of study drug will be assessed for safety and to see how well patients can tolerate it. If the new dose does not cause severe side effects, a higher dose will be given. This process will continue until the highest dose that can be given to patients with acceptable, manageable, and reversible side effects has been reached.
The study is sponsored by Keystone Nano, INC and is funded by the National Institutes of Health. The investigator in charge of this study at MUSC is Carolyn Britten, MD. The study is being done at 3 sites. Approximately 48 people will take part study-wide and 8 will take part at MUSC.

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

Change_preferences

-- OR --

Create_login