UC Davis Health Clinical Studies

Experimental Pembrolizumab Alone or Combined With Pemetrexed and Carboplatin For Advanced Non-Small Cell Lung Cancer (NSCLC)

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This study is being done to answer the following questions: Does immunotherapy with MK-3475 (pembrolizumab) alone improve overall survival? This will be compared to combination therapy with chemotherapy, in patients with your type of cancer. Does additional treatment with chemotherapy following immunotherapy alone also improve overall survival? We are doing this study because we want to compare these two usual approaches to cancer treatment. The usual approach is defined as care most people get for PD-L1 positive non-squamous non-small cell lung cancer.

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

A Study of Experimental Therapy With Nivolumab For Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

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This study is being done to answer the following question: Can we safely and effectively treat your cancer with nivolumab given any of the following auto-immune diseases? -Rheumatoid arthritis -Polymyalgia rheumatica -Sjogrens -Ulcerative colitis -Crohn's disease -Systemic lupus erythroderma -Dermatomyositis -Multiple sclerosis Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer and your auto-immune disease. The usual approach is defined as care most people get for their cancer while having an auto-immune disease. Treatment with nivolumab is considered experimental. It is not currently approved by the FDA for cancer in people with auto-immune diseases.

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

The PROSpect Study: A Pediatric Study to Test the Best Breathing Position for Children When They Are Sick

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This study is being done to learn the best way to help children breathe when they are sick. When children’s lungs are very sick they are on a machine to help them breathe. There are different types of breathing machines that can be used. The two types are usual or high frequency: 1) A usual breathing machine imitates a person’s normal breathing. 2) A high frequency breathing machine delivers fast and shallow breaths. There are also different positions a child can be in while on a breathing machine: 1) Lying on their back with a slight change in position every two hours. 2) Lying on their stomach for at least 16 hours each day with a slight change in position every 2 hours. When needed for medical care, your child will be turned on their back, and then returned to lying on his or her stomach. At UC Davis, we use both types of breathing machines and place children in both positions. The main purpose of this study is to find out if one approach is better than others in reducing the number of days a child spends on a breathing machine. The length of time your child spends on the breathing machine may be shorter or longer from taking part in this study.

Other study
Any, age -1 to 18 years old

A Follow-up Study of Long Term Treatment With Experimental Nintedanib For Progressive Fibrosing Interstitial Lung Disease

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This study is being done to find out how safe it is for patients to take experimental nintedanib long-term. We hope to learn how well it is tolerated (accepted) in patients who completed the INBUILD® study. Nintedanib has not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for PF-ILD. Nintedanib is experimental for this study. It has been approved by the FDA to treat idiopathic pulmonary fibrosis. This study is for research purposes only and will help to gain information for providing better or new treatments for people in the future. This is different from regular medical care, where the purpose is to help each individual person.

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

A Study of the Experimental Medicine Alvelestat (MPH966) for Chronic Obstructive Pulmonary Disease (COPD)

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Alpha-1 antitrypsin (α1AT) is a protein. It is made in the liver, circulates in the bloodstream, and protects lung tissue from an enzyme called elastase. Elastase is released by your white blood cells (a type of cell in your blood that helps fight infections). Elastase fights infection in the lungs, but can attack healthy lung tissue if not controlled by α1AT. This study is being done to see if the study drug, alvelestat (MPH966), can inhibit the activity of elastase. Alvelestat is an experimental drug which has not been approved by the FDA.

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

A Study Evaluating the Long-term Safety and Effectiveness of Experimental VX-445 Combination Therapy for Cystic Fibrosis (CF)

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The purpose of this research study is to learn more about the safety and effectiveness of VX-445. It will be used in combination with TEZ and IVA in patients with cystic fibrosis (CF). · The triple combination VX-445/TEZ/IVA is an experimental drug. “Experimental” means the drug is not approved by the FDA. It is still being tested for safety and effectiveness. · TEZ in combination with IVA (TEZ/IVA) is approved in certain countries for use in some people living with CF who are 12 years or older. · IVA is approved in a number of countries globally, for use in some people living with CF as young as 2 years old. If you would like to know in which countries or for which people living with CF TEZ/IVA or IVA has been approved, please ask your Study Doctor.

Drug study, Phase 3
Any, age 12 years or older

A Study of the Safety and Effectiveness of Experimental Ralinepag for Patients With Pulmonary Arterial Hypertension

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This study will test an experimental medication called Ralinepag. It will be used in the treatment of pulmonary arterial hypertension (PAH). Ralinepag has not been approved by the FDA and is not available by prescription. Ralinepag is designed to activate the prostacyclin receptor. The prostacyclin receptor is a protein found on cells of blood vessels. A naturally occurring substance called prostacyclin attaches to it. In patients with PAH, reduced activity of the prostacyclin receptors can cause the blood vessels in the lungs to become narrow. This it harder for the blood to flow. By increasing the activity of prostacyclin receptors, we hope that Ralinepag may improve blood flow to the lungs. This may improve symptoms of PAH (shortness of breath while exercising, dizziness, high blood pressure). We are doing this research study to test whether the study drug provides the expected benefits to patients who take it. This study is being done at UC Davis Health and at other sites around the U.S.

Drug study, Phase 3
Any, age 18 to 75 years old

A Study of Experimental Fenretinide (LAU-7b) for Cystic Fibrosis in Adults

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Cystic fibrosis (CF) is a multi-system disease affecting the respiratory tract. It involves the lungs, nose, and sinuses, pancreas, liver, sweat glands, and reproductive organs. The lungs often experience ongoing infection (usually with bacteria called Pseudomonas aeruginosa). It sustains out-of-control inflammation that results in irreversible damage. This is a research study of an experimental drug called fenretinide (LAU-7b). Experimental means that this drug has not been approved by the U.S. Food and Drug Administration (FDA). The study drug (LAU-7b) is a derivative of Vitamin A. The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function. We hope it will reduce the persistent inflammation in the lung. We also hope it improves the lung's capacity to defend against bacteria such as Pseudomonas aeruginosa. The main goals of this study are to determine if fenretinide: Is safe and well tolerated Improves lung function as measured by spirometry. Spirometry is a routinely performed test to measure lung function.

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

A Study of the Safety and Effectiveness of the Experimental Medicine Tisotumab Vedotin for Solid Tumors

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We are doing this study to find out if tisotumab vedotin treats solid tumor cancer. We want to see if patients with your kind of cancer respond to the drug. We want to see how long it takes patients to respond to tisotumab vedotin and how long the response lasts. We also want to learn more about any side effects patients experience during treatment with tisotumab vedotin. Tisotumab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts. ● Antibody: Antibodies are part of your immune system. Usually, they help protect you from getting sick. In tisotumab vedotin, we are using an antibody that is designed to find and stick to the solid tumor cancer cells in your body. ● Drug: the part of the ADC that kills cells. The cell-killing part of tisotumab vedotin is a drug called MMAE. In tisotumab vedotin, the antibody part is designed to stick to cancer cells so that the drug part can kill them. It may also stick to some non-cancer cells in your body. We are asking patients with four types of solid tumor cancer to take part in this study. The four types are colorectal cancer, squamous non-small cell lung cancer (NSCLC), pancreatic cancer, and squamous cell cancer of the head and neck (SCCHN). More than 200 people with cancer have already been given tisotumab vedotin in research studies. These studies tested different doses of tisotumab vedotin to see if it is safe in people. They also tested how well tisotumab vedotin works to treat cancer.

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