UC Davis Health Clinical Studies

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 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 Experimental Baricitinib For People With Primary Biliary Cholangitis (destroyed liver bile ducts) Who Cannot Take UDCA

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"Baricitinib is an FDA approved drug at 2-mg dose for rheumatoid arthritis. In this study, baricitinib is an experimental drug. The study drug blocks the effects of proteins in the body called Janus kinases. “Experimental” means that the study drug being tested has not been approved by the FDA for the use described in this study. The FDA is allowing the use of this drug for research. The main reason for you to take part in this study is to help answer the following research question(s): • Whether baricitinib taken at 2-mg and 4-mg once a day can help study participants with primary biliary cholangitis • How baricitinib taken at 4-mg once a day compares to placebo (a pill that looks like the study drug but has no medicine) treatment in primary biliary cholangitis • The safety of baricitinib taken at 2-mg and 4-mg once a day compared to placebo and any side effects you might have when you take it

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

A Study of Experimental Medicine VAY736 For Autoimmune Hepatitis

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The purpose of the study is to find out if:  Experimental VAY736/ianalumab can help to treat patients with autoimmune hepatitis  To see if it is safe for autoimmune hepatitis patients to take VAY736/ianalumab  To compare different dosages of VAY736/ianalumab to see which one works best  To see if using VAY736/ianalumab on top of standard treatment is better than using no active treatment (placebo) on top of standard treatment. Standard treatment for autoimmune hepatitis is usually steroids or anti-inflammatory medicines (azathioprines). These treatments can prevent the immune system from attacking the liver. They are effective for most patients with autoimmune hepatitis. Approximately 25% of autoimmune hepatitis patients do not completely respond to treatment or cannot tolerate these drugs. This study is for patients whose disease did not respond well to or could not tolerate standard treatment. VAY736/ianalumab is a medicine which has not yet been approved by FDA for the treatment of patients with your medical condition. This study drug is experimental and it has not yet been demonstrated to be effective for the treatment of autoimmune hepatitis.

Biological study, Phase [/2/,/ /3/]
Any, age 18 to 75 years old

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

A Study of Experimental Obeticholic Acid For Primary Biliary Cholangitis (inflammation and scarring of liver bile ducts)

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This study is for people with primary biliary cholangitis (also known as primary biliary cirrhosis or PBC). Because of your condition, you may be eligible for a research study on an investigational drug for your condition. The Sponsor of this study, Intercept Pharmaceuticals, Inc., is trying to learn more about obeticholic acid (also known as OCA). We want to know its effect on your PBC condition when given with ursodeoxycholic acid (UDCA). OCA (Ocaliva) has been approved in several countries (including the United States, Canada, and Europe) for the treatment of PBC. As an approved drug, OCA may be commercially available, or can be purchased to treat patients with your condition, PBC. In this study, OCA is an investigational drug (also called a study drug). This means that OCA is being tested to obtain more information about its effects on PBC. The investigational drug, OCA, is a modified (manmade) version of a natural compound made in the liver called a bile acid. Bile acids are used by the body to help with digestion and have additional effects on liver function. The purpose of this study is to find out how study drug, OCA, is absorbed and distributed through the body. We hope to determine the chemical changes of the study drug while it is in the body, and identify how the study drug is excreted out of the body. This is called pharmacokinetics, or PK. The Sponsor will also be studying the safety of OCA.

Drug study, Phase 4
Any, age 18 years or older

A Study of the Experimental Medicine Olaparib For Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations

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You are being asked to take part in this study because you have a tumor with an abnormal gene called IDH1 or IDH2. Your tumor may have grown or has recurred. There is no standard FDA approved treatment that is specific for people with this kind of abnormality in the tumor. People who are not in a study are usually treated with standard chemotherapy, immunotherapy, targeted therapies, surgery or radiation. These treatments may reduce your symptoms and slow down the growth of your tumor, but they are not curative. The purpose of this study is to test any good and bad effects of a drug called Olaparib. Researchers showed in the laboratory that Olaparib can shrink tumors like yours or stop its growth. Olaparib has already been FDAapproved to treat other cancers that have similar abnormalities. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size. Olaparib could shrink your cancer but it could also cause side effects. There will be about 145 people taking part in this study.

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

A Study of the Experimental Combination of Olaparib and Ramucirumab For Metastatic Gastric or Gastroesophageal Junction Cancer

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This clinical trial will take part in 2 separate phases as described below. Phase 1: The purpose of this portion of the study is to test the safety of the combination of olaparib and ramucirumab. Olaparib will be given at different doses to find out what side effects, if any, it has on patients. There will be about 9 patients taking part in the phase 1 portion of the study. This will be conducted before phase 2 begins, which is described below. Phase 2: The purpose of this study is to test any effects of the combination of olaparib and ramucirumab. The combination of olaparib and ramucirumab could shrink your cancer, but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer compared to its present size. Ramucirumab has already been FDA-approved to treat gastric cancer, and olaparib has been approved for the treatment of other cancers. Ramucirumab decreases the oxygen delivery to tumor cells. This inhibits tumor growth and has also been shown to decrease the ability of tumors to repair DNA effectively. Olaparib also inhibits the ability for tumors to repair DNA and is most effective in tumors that already have impaired DNA repair. We hope that combining olaparib with ramucirumab will help get rid of tumors better than just the ramucirumab used alone. There will be 40 patients taking part in the phase 2 portion of the study. You will only be enrolled in one phase of the study, phase 1 or 2. Your study doctor will tell you in which study phase you will be enrolled.

Other study, Phase [/1/,/ /2/]
Any, age 18 years or older

UC Davis HCV Telementoring Program (ECHO-Plus)

We are with you every step of the way to be the next HCV Champion

We are seeking primary care providers, like you, to become "champions" for Hepatitis C care in your community. We hope you will become the local experts for HCV care and allow a greater number of patients to be managed and cured for their hepatitis C locally. It is the mission of ECHO-Plus, in collaboration with University of California, San Francisco (UCSF), to advance the knowledge and skills in management of HCV among primary care providers through one-on-one telementoring. You can expect the following benefits from participating: • Patient, provider (you), and UC Davis specialist relationship • 1 CME credit for participation in HCV education presentation • Direct, patient-based, real-time consultation and education with Specialist • Telementoring equipment (camera and speaker) will be provided to you • One-to-One telementoring that is billable to your practice • Availability of UC Davis pharmacist for education and support • HCV-VOICE: Clinical warm line

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