UC Davis Health Clinical Studies

Experimental Combination of Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel For Advanced Biliary Tract Cancers

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Biliary cancer is a form of cancer that develops in the bile duct system. This system connects the liver, gallbladder, and small intestine. The biliary ducts move bile, a fluid that helps digest fats, to the small intestine. The purpose of this study is to compare the effects of an experimental combination treatment. I twill be used to treat newly Diagnosed, Advanced Biliary Tract Cancers. The drug nab-paclitaxel will be added to standard treatment with the drugs cisplatin and gemcitabine. This treatment will be compared to treatment with cisplatin and gemcitabine alone. Nabpaclitaxel is an FDA-approved drug for other diseases. It is experimental in this study. The addition of the study drug nab-paclitaxel could shrink your cancer. It could also cause side effects. This study will help the study team learn whether this different approach is better, the same, or worse than standard treatment. In this study, you will get either: - cisplatin and gemcitabine, or - nab-paclitaxel with cisplatin and gemcitabine.

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

Experimental Combination of Anetumab Ravtansine, Nivolumab, Ipilimumab, & Gemcitabine Hydrochloride in Advanced Pancreatic Cancer

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This study is being done to answer the following questions: 1) Are the combinations of the following medications safe when given together? o Group 1: anetumab ravtansine and nivolumab o Group 2: anetumab ravtansine, nivolumab and ipilimumab o Group 3: anetumab ravtansine, gemcitabine and nivolumab 2) What effect (good and/or bad) does this intervention have on you and your cancer? Anetumab ravtansine is a drug that targets a protein called mesothelin, which can be found in some pancreatic tumors. We are doing this study to see if it has anti-tumor activity in your type of cancer. It will be used in combination with other medications as described above (Group 1, Group 2 or Group 3). Your tumor was tested to see if it has mesothelin. The combination therapies in this study are experimental. They have not been approved by the FDA for treatment of pancreatic cancer. Gemcitabine is approved by the FDA. Anetumab ravtansine, nivolumab and ipilimumab are all experimental. Chemotherapy is the standard treatment for pancreatic cancer spread outside of the pancreas and cannot be removed with surgery. The usual medications used and approved by FDA are: - Gemcitabine - Gemcitabine and nab-paclitaxel - Gemcitabine and erlotinib - Oxaliplatin, irinotecan, leucovorin, and fluorouracil (5-FU) When the disease grows (progresses) despite one of these interventions, there is no standard option. Some of the above mentioned medications can be tried. Other options include radiotherapy, surgery or comfort care to relieve the symptoms from the cancer. This option is defined as best supportive care.

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

A Study of the Safety and Effectiveness of Experimental Lonafarnib / Ritonavir for Chronic Hepatitis D Virus Infection

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This study is for patients with chronic (long-lasting) hepatitis D virus (HDV) infection. Potential participants must be taking or be willing to begin taking nucleotide/nucleoside inhibitors (entecavir or tenofovir). These nucleotide/nucleoside inhibitors must be taken for at least 12 weeks to 6 months before beginning the study treatment. The purpose of this study is to determine whether the study drugs will reduce the amount of HDV in your blood. Other purposes of this study are: - to determine the effects of the study drugs on your liver - to determine if taking the study drugs makes your quality of life better - to evaluate the safety of the study drugs The Sponsor is conducting this study to find new treatments for HDV. This research study is designed to learn more about an investigational drug called lonafarnib. It is being developed to treat chronic HDV infection as well as other conditions. "Investigational" means lonafarnib is not yet approved by the FDA for prescription or over the-counter (OTC) use. Lonafarnib will be taken in combination with an approved drug called ritonavir. Ritonavir is commonly used in the treatment of hepatitis C at comparable dosing to what will be used in this study. In this study, ritonavir is used as a “booster” to increase the amount of lonafarnib in your body. A “booster” is a drug that prevents your body from breaking down lonafarnib, so it can work longer. Some patients in this study will take an interferon medicine approved for treating HBV and hepatitis C virus (HCV) infections. This medicine is called peginterferon-alfa-2a (abbreviated as PEG IFN-alfa-2a). PEG IFN-alfa-2a will be a potential added medicine in this study. We hope to determine if it improves the treatment outcome when taken with lonafarnib and ritonavir. Peginterferon-alfa-2a is a solution that is injected under the skin once per week.

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

A Study of the Effect of an Oral Vaccine on the Digestive System

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The purpose of this study is to: 1. Determine whether ingesting the standard, 4-doses of a live, weakened typhoid fever vaccine will cause a temporary leaky gut and inflammation. Leaky gut is a condition when the gut lining becomes more permeable, or “leaky”, for substances in the gut to pass through to the tissues beneath it. 2. Compare the gut leakiness caused by this vaccine to the gut leakiness caused by a short-term ingestion of aspirin. 3. Examine whether the size of the body’s natural immune response to this vaccine is associated with gut leakiness and inflammation of similar size.

Biological study, Phase 1
Female, age 18 to 49 years old

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
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