UC Davis Health Clinical Studies

A Study of the Effectiveness and Safety of Experimental Pembrolizumab Plus Lenvatinib for Selected Solid Tumors

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The purpose of this study is to: o Test the safety of the study drugs, lenvatinib and pembrolizumab when given together o See how well they work to control or stop your cancer o See how well your body handles the study drugs o Find out how lenvatinib is absorbed and broken down in your body when given with pembrolizumab o See if the study drugs help patients live longer Pembrolizumab (MK-3475) is also known as KEYTRUDA®. Lenvatinib (MK-7902/E7080) is also known as Lenvima®. These drugs have been approved by certain health authorities for the treatment of various cancers. However, they may not be approved for your exact type of cancer in your country. Getting lenvatinib and pembrolizumab together is considered experimental.

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

A Study of Experimental Autologous Dendritic (immune) Cells With Autologous Tumor Antigens for Newly-Diagnosed Glioblastoma

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This study will test the safety and effectiveness of a patient-specific cellular immunotherapy. It will be given to patients who have newly-diagnosed glioblastoma cancer. The Sponsor of the study is AIVITA Biomedical, Inc. Our study team is helping to determine if an experimental immunotherapy (AV-GBM-1) will increase survival without harmful effects. AV-GBM-1 consists of a patient’s own dendritic cells (a type of immune cell). It is loaded with a patient’s own tumor-associated antigens (proteins that are made by their cancer cells) . The goal of this immunotherapy is to make a patient’s immune response better at fighting the existing tumor and to increase survival. GM-CSF is a natural growth factor that stimulates growth of white blood cells in the body. In this study, GM-CSF is given to enhance the immune effects of the treatment products. AV-GBM-1 is an experimental drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for standard use in the practice of medicine.

Biological study, Phase 2
Any, age 18 to 70 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

A Study of Experimetnal Tabelecleucel After Failed Standard Treatment for Solid Organ Transplants With Epstein-Barr Virus

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This is a research study for patients with EBV-associated Post-Transplant Lymphoproliferative Disorder (EBV-PTLD). The study is for patients after a solid organ transplant (SOT) that didn’t respond to rituximab therapy with or without chemotherapy. This study will use a new treatment called tabelecleucel (also known as ATA129). Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as “mono”. Almost all adults have had EBV. For most people, EBV never causes a health problem. For people whose immune system is not working properly EBV can cause certain diseases where cells grow abnormally. This may happen in people who have had a transplant and those who have immune disorders. EBV-associated Post-Transplant Lymphoproliferative Disease (EBV-PTLD) can occur after a solid organ transplant (SOT). EBV infects immune cells in your blood, called B cells. In patients who have had an SOT, their immune system is suppressed because of the transplant. These infected immune cells can become cancerous. This research study is for patients who have EBV-PTLD following an SOT. It has not responded well to treatment with rituximab or rituximab and chemotherapy. Participants will receive experimetnal tabelecleucel. This is a product containing special immune allogeneic cells. The cells are called EBV-Cytotoxic T Lymphocytes (EBV-CTLs). They are made in the laboratory starting with cells from a healthy person who is immune to EBV. Your treatment will be selected specifically for you from a library of frozen tabelecleucel. It will be matched using certain human leukocyte antigens (HLAs). Treatment with tabelecleucel is experimental and is not approved by the FDA for use in the general public. It has been approved for testing in clinical trials. Tabelecleucel is made by taking donor cells from a healthy person. The cells that fight EBV (EBVCTLs) are grown in a laboratory for several weeks. They are then stored in a freezer until they are matched to a patient needing treatment. The cells are not genetically modified. This process is repeated using multiple donors in order to create a library of tabelecleucel products.

Biological study, Phase 3
Any, age -1 years or older
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