UC Davis Health Clinical Studies

A Study of the Experimental Combination of Axitinib and Nivolumab For Unresectable or Metastatic Renal Cell Carcinoma

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In this study, we are interested in learning more about how to treat tRCC. To do this, we will test 2 drugs (axinitib and nivolumab) given alone or given together. The drugs axitinib and nivolumab have been used to treat adults and children with different types of cancer, including RCC. Axitinib is a chemotherapy drug that works by stopping the growth of new blood vessels to cancer cells. If left untreated, these feed the cancer cells and allow them to grow. Nivolumab is an immunotherapy that works by helping the body’s immune system (your body’s own defense system) to recognize and attack the cancer cells. Both axitinib and nivolumab have been approved by the FDA for treating RCC. However, using these 2 drugs together is considered experimental. Also, this will be the first formal study of treatments specifically for tRCC. We would like to know if using these drugs alone or together for the treatment of tRCC will be well-tolerated in subjects. Subjects are people who are agree to take part in this study. The overall goal of this study is to find out what effects, good and/or bad, axitinib and nivolumab have on subjects with tRCC when the drugs are given alone or in combination.

Drug study, Phase 2
Any, age 1 years or older

A Study of Experimental Combination Therapy With Pembrolizumab and sEphB4-HSA For Urothelial Carcinoma (bladder cancer)

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You are invited to take part in this study because you have urothelial carcinoma (a type of bladder cancer). This study is testing the combination of two experimental drugs: - Pembrolizumab (by Merck & Co, Inc) and - sEphB4-HAS (by VasGene Therapeutics, Inc). Pembrolizumab is approved in the U.S. and several other countries for the treatment of malignant melanoma (a type of skin cancer) and lung cancer. Pembrolizumab is considered experimental in this study, because it has not been approved by the FDA for the treatment of advanced solid tumors. sEphB4-HAS is considered experimental because it has not been approved by the FDA. All participants in this study will receive both experimental drugs.

Procedure study, Phase 2
Any, age 18 years or older

A Study of Experimental PET Scan for Renal Cell Carcinoma (kidney cancer)

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The current treatment for kidney cancer only benefits some patients. It can be costly and toxic. To check if treatment is working, doctors use computed tomography (CT) and/or magnetic resonance imaging (MRI). This imaging is done approximately two months after cancer treatment. In some cases where treatment is not working, those patients are unnecessarily exposed to toxic treatment. They can then switch to other potentially effective therapy. The purpose of this study is to learn a new way of imaging cancer early during the treatment course (two weeks). This will help determine if the treatment is effective. We will explore the benefit of functional PET technique for earlier prediction of cancer response.

Diagnostic Test study
Any, age 21 to 80 years old

A Study of Experimental Combination Treatment with Chemotherapy, Nivolumab, and / or BMS-986205 for Bladder Cancer

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This study will test the effectiveness (how well the drug works), safety, and side effects of the experimental drug called BMS-986205. It will be tested in combination with another cancer medicine called nivolumab plus chemotherapy. This study is for patients who have bladder cancer that has grown into the muscle wall of the bladder. These drugs will be compared to just chemotherapy. BMS-986205 is a small molecule and nivolumab is a human monoclonal antibody. A small molecule such as BMS-986205 is a chemical that is designed to block the function of a protein (called an enzyme) within the body. BMS-986205 is an IDO1 inhibitor. Blocking the IDO pathway may help your immune system to fight abnormal cancer cells in the body. An antibody is a type of protein that your immune system (the body's defense system against harmful particles) uses. Antibodies find and destroy foreign particles (such as bacteria and viruses). Scientists can now make antibodies in the laboratory and produce them for the treatment of many different diseases. Nivolumab is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can prevent PD-1 from shutting down the immune system. This allows immune cells to recognize and destroy cancer cells. Nivolumab is approved to treat certain cancer types.

Biological study, Phase 3
Any, age 18 years or older

A Study of the Experimental Cytomegalovirus (CMV) Vaccine (HB-101) in Kidney Transplant Patients

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The purpose of this clinical research study is to see if an investigational anti-Cytomegalovirus (CMV) vaccine known as HB-101 is safe to use and helps patients. The main purpose of this study is find out:  How well HB-101 could protect from significant CMV infections.  The side effects of HB-101. CMV is a common infection that can be dangerous when your defense against commonly mild infections is low. For example, this can happen in patients who receive a kidney from a donor. Most people whose immune system is working well with CMV infection have no symptoms. If any, symptoms are mild illness such as fever, sore throat, fatigue, and swollen glands. However if your immune system is weak, CMV can affect your lung, gut, eye or other organs and can create severe damages. This study involves the use of an new investigational anti-CMV vaccine known as HB-101. HB-101 is a vaccine that is believed to prevent CMV infection after kidney transplant by forming antibodies and stimulating your immune cells against CMV. This vaccine doesn’t contain eggs or mercury. HB-101 contains a Genetically Modified Organism (GMO). The vaccine uses genes from two different viruses, but it can’t reproduce any infectious viruses in your body. The HB-101 vaccine is constructed from parts of a LCMV. The parts of the LCMV used is not alive and cannot reproduce or give you an infection. When HB-101 vaccine is introduced inside your body, it tricks your body in thinking it has CMV. It teaches your immune system to make antibodies to protect you against CMV infection. The HB-101 vaccine is not live and can’t spread in your body or outside your body in the environment.

Biological study, Phase 2
Any, age 18 to 99 years old

A Study of Oral vs Transdermal (through skin patch) Oxybutynin for Post-surgical Bladder Pain and Urgency in Children

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After bladder surgery, most patients have urinary urgency (the feeling of having to urinate). Doctors may give a medication to help treat or prevent this feeling. The medication Ditropan (oxybutynin) relaxes the bladder muscle and is currently given. This research study will test if oxybutynin works better in the oral form (liquid) or given through a skin patch (transdermal). Ultimately, we want to find the best form of the medicine for our patients to feel better after surgery.

Drug study, Phase 3
Any, age 4 to 8 years old

An Exercise Study Testing Muscle Mitochondria (energy production) in Chronic Kidney Disease

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The purpose of this research study is to find out if exercise improves how well the mitochondria work. We also want to know if exercise improves ability to perform physical tasks. Finally, we will also test several components in the blood which may be related to physical abilities. We are doing this research because exercise may improve the overall balance of these components. What we learn in this study may help us to better understand the mitochondria and muscle in people with kidney disease. We hope to use this knowledge to improve their ability to be active and independent.

Behavioral study, Phase 2
Any, age 18 to 75 years old

Codex: A Study of Experimental Inodiftagene Vixteplasmid (BC-819) in Unresponsive Non-Muscle Invasive Bladder Cancer

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This study is for patients who have bladder cancer and have been treated with BCG (Bacillus Calmette-Guerin). The cancer has returned after treatment(s). This research study will test an experimental medicine named BC-819. The study team hopes to learn if BC-819 can prevent or delay tumor recurrence. It will be tested in patients with non-muscle invasive bladder cancer that has become unresponsive to BCG treatment. BC-819 is made from DNA, a type of genetic material. DNA is a short name for deoxyribonucleic acid. BC-819 is a liquid solution that contains many small pieces of DNA which are called DNA plasmids. The DNA plasmid works by causing a change inside cancer cells that have a gene called H19. The plasmid does not function in your normal cells, because these cells do not have the H19 gene. The way the plasmids enter the cells in your body is considered gene transfer. Once inside a malignant cell, the plasmid is toxic and causes the cancer cell to die. The study agent solution also contains a chemical called PEI (polyethyleneimine). PEI helps the plasmid to enter the cancer cells. The BC-819/PEI liquid solution is given through a tube called a Foley catheter. This allows the liquid solution to flow directly into the bladder. This is the same way BCG was given.

Drug study, Phase 2
Any, age 18 years or older
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