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.
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.
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.
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.
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.
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.
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.
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.
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.