UC Davis Health Clinical Studies

A Study of Experimental TTX-030 With or Without Immunotherapy or Chemotherapy for Advanced Cancers

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You are invited to take part in a voluntary research study to test an investigational drug called TTX-030. It will be given alone or in combination with either one of the FDA-approved drugs: Pembrolizumab, Docetaxel, or Gemcitabine and Nab-paclitaxel. The purpose of this research study is to find out the highest dose of TTX-030 that can be given to subjects. We hope to learn its side effects, the level of investigational drug in your blood and how the body gets rid of the drug after dosing. This study involves 4 treatment groups (arms). An ARM of a research study is a group of patients receiving a specific treatment. Treatment visits will involve Arms 1, 2, 3, which is a 21- day cycle, and Arm 4, a 28-day cycle. One cycle is 21 or 28 days, which is equivalent to 3 or 4 weeks, depending which Arm you participate in. You will visit the study site 4-5 times during Cycle 1, 2 times during Cycle 2, 1-2 times during Cycle 3, and 1 time for each following cycle.

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

Experimental Combination Treatment For Chemotherapy-Refractory (treatment resistant) Metastatic Pancreatic Cancer

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This is a research study for cancer treatment resistant metastatic pancreatic cancer. It will test the safety and effectiveness of an experimental combination treatment. The combination treatment used in this study includes nivolumab, SD-101 and radiation therapy. The study team hopes to learn how patients with metastatic pancreatic cancer respond to this combination. The study drug Nivolumab has not been approved by the FDA for this particular type of cancer. It is approved for other types of cancer. This study will also use SD-101. SD-101 is an experimental drug injected by needle into your tumor. Experimental means that the drug has not been approved by the FDA. This combination treatment is experimental for chemotherapy refractory metastatic pancreatic adenocarcinoma.

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

A Rollover Study of Experimental Avelumab for Solid Tumor Cancer

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Avelumab is a monoclonal antibody. This means it is an antibody that is active against a single specific target structure. Antibodies are usually produced naturally by the body’s immune system. They protect the body from sources of infection or agents that may be harmful to the body. Artificial antibodies, such as the study drug, can be made into medications to help prevent the growth or spread of cancer. The specific target structure that the study drug is active against may be present on the type of cancer you have. You are invited to take part in this roll-over clinical research study. It is for patients who were treated with the study drug avelumab in another clinical research study. Participants from several studies on avelumab (referred to as “parent studies”) are invited to take part.

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

A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)

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This research study will test if experimental OrcaGraft can be safely given to patients. It will be studied as a stem cell transplant in patients with blood cancers and pre-cancerous conditions. We are doing this research because some transplants can cause complications. One complication is called graft-versus-host-disease (GVHD). GVHD causes donor cells to attack recipient tissues. OrcaGraft is designed to minimize or eliminate potential complications and provide a safer transplant. This study will see if OrcaGraft is safe to use. We will also collect data about the best dose of cells that make up a part of OrcaGraft. This could provide data to make the composition of OrcaGraft better in the future. This study is being done at UC Davis Health and at other sites around the U.S.

Biological study, Phase 1
Any, age 18 to 65 years old

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 Experimental Pembrolizumab (MK-3475) in Combination With Chemotherapy & Endocrine Therapy for Breast Cancer

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The purpose of this study is to: o Test the safety of the study drug, pembrolizumab (MK-3475), with certain types of chemotherapy and endocrine therapy. o See how well the study drug, pembrolizumab, works when combined with chemotherapy and endocrine therapy. o To see if combining the study drug with chemotherapy will have a positive outcome on your surgery, compared to these treatments alone. o To see if combining the study drug with chemotherapy and endocrine therapy keeps your cancer from returning sooner. o To see if combining the study drug with chemotherapy and endocrine therapy helps you live longer. o See how your body handles the study drug. This is a study to test Pembrolizumab for your type of breast cancer. It has not been approved by the FDA to treat breast cancer, but it is approved to treat other types of cancer. The chemotherapies being used in this study (Paclitaxel, Doxorubicin, Epirubicin and Cyclophosphamide) are approved. They are widely used, as a treatment for your type of breast cancer. Endocrine therapy is also approved to treat your type of breast cancer. You will receive endocrine therapy as part of your treatment during the study. The use of these drugs together with pembrolizumab is experimental. “Experimental” means that the study drug is currently being tested. It is not approved by the U.S. FDA

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

A Study of the Safety and Effectiveness of Experimental BIVV003 for Stem Cell Transplant for Severe Sickle Cell Disease

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This research study is being done to see if the investigational product being studied is well-tolerated. We hope to understand the safety of the product, and to see if it improves the health of patients with sickle cell disease. Sickle cell disease is an inherited disorder. Red blood cells become sickle shaped (shaped like a crescent) and rigid. This leads to a variety of serious complications throughout the body. It is possible to replace the abnormal red blood cells in sickle cell patients with normal red blood cells. This is done by a bone marrow transplant from a matched donor. The investigational product to be tested in the present study is known by its code name BIVV003. BIVV003 is made from stem cells that will be collected from your own blood. Stem cells are the primitive cells that make all your blood cells. The stem cells contain the genetic code for making hemoglobin. A portion of that code decides which kind of hemoglobin is made: adult, which is the sickle hemoglobin in your case, or fetal (baby hemoglobin). Bioverativ Therapeutics Inc. has found a way to change this code to make more of the fetal hemoglobin and less of the sickle hemoglobin.

Biological study, Phase [/1/,/ /2/]
Any, age 18 to 35 years old

A Study of the Safety and Activity of Experimental ABBV-368 for Advanced Solid Tumors

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Purpose of Study: - To see if the study drug is safe and tolerable for subjects with locally advanced solid tumors - To find out the side-effects of ABBV-368 alone and combined with ABBV-181 in patients with advanced solid tumors - To find out how your body handles ABBV-368 alone and in combination with ABBV-181 - To decide on the dose of ABBV-368 that will be best to use in future studies - To find out if substances (biomarkers) found in your blood or tumor tissue may show the effects or progress of the cancer and the activity ABBV-368 has on it - To help explain how to improve the treatment and/or diagnosis of cancer Purpose of Biomarker and Exploratory Research - To find out why some patients with the disease being studied respond better or worse to the study drug or drugs of the same or similar class - To find out how the disease being studied and related conditions develop and progress and how they can be diagnosed, monitored, or treated - To develop tests to identify which patients are likely to have different diseases, respond to the study drug or drugs of the same or similar class, or to predict the progression of the disease being studied - To possibly develop new therapies, research methods, or technologies - To understand the drug effects on the body and immune system Every participant in the main study will be asked to provide samples for optional exploratory research.

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