UC Davis Health Clinical Studies

A Study of the Experimental Medicine ASP8374 Combined with Pembrolizumab for Advanced Solid Tumors

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You are being asked to take part in this research study because you have a tumor that cannot be removed through surgery (unresectable). The tumor may have spread (metastasized) to other parts of your body. In this study, participants will receive experimental ASP8374 alone or combined with pembrolizumab. The main purpose of the study is to determine at what dose the study drug (ASP8374 or ASP8374 plus pembrolizumab) is safe and tolerated. We hope to learn how the blood processes it. It will be studied in patients with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to test if the study treatment causes tumors to shrink. During this period, the study drug will be continuously tested to determine if it is safe and tolerated by patients. This is the first time we are testing ASP8374 in humans. Studies in animals showed that the drug is safe to be tested in humans. This medicine called ASP8374 is experimental and has not been approved by the FDA for the treatment of any disease or type of tumor. Pembrolizumab has been approved by the FDA for use in patients with skin, lung and other cancers. The information collected in this study is necessary to find out whether the treatment tested is safe. The information about you will be kept anonymous. Information may be used to seek FDA approval to market the medicine for advanced (unresectable) or metastatic tumors.

Drug study, Phase 1
Any, age 18 years or older

A Study of Experimental INCMGA00012 For Squamous Carcinoma of the Anal Canal After Platinum-Based Chemotherapy

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You are being asked to take part in this research study because you have anal cancer. Your cancer has not responded to platinum-based chemotherapy. This study will test whether INCMGA00012 is safe and effective to treat Squamous Carcinoma of the Anal Canal (SCAC). SCAC is a rare cancer of the digestive system that can spread rapidly to other areas of the body. Immunotherapy is a new approach to treatment in advanced SCAC. In this study you and all other participants will receive INCMGA00012. INCMGA00012 is an experimental drug that is being studied for use in the treatment of Squamous Carcinoma of the Anal Canal (SCAC). “Experimental” means that INCMGA00012 has not been approved by the FDA. INCMGA00012 is designed to activate the immune system.

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

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
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