UC Davis Health Clinical Studies

Safety and Effectiveness of Experimental IMC-C103C With or Without Atezolizumab for Advanced MAGE-A4-positive Cancer

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This study will test increasing doses of the experimetnal study drug, IMC-C103C. It will be given alone and in combination with the drug atezolizumab. The goal is to find the highest dose that is safe to give to people with advanced cancer. This study is the first time IMC-C103C is being tested in people. IMC-C103C is an “experimental medication.” This means that it has not yet been approved by the FDA for use by doctors in treating cancer. IMC-C103C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. IMCC103C has 2 parts. The first part is called a “T cell receptor.” It sticks very tightly to tumor cells that makes the markers “HLAA*02:01” and “MAGE-A4”. The second part is called an “anti-CD3 scFv.” It sticks to a T cell (a type of white blood cell that helps protect your body against disease). IMC-C103C makes the T cell stick to the cancer cell, which then sends a signal to attack the tumor. Atezolizumab is a FDA-approved medication for NSCLC and urothelial cancer. Atezolizumab is an immunotherapy drug (a drug that helps the immune system fight cancer) targeting a protein called PD-L1.

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

A Study of Experimental RMC-4630 and Cobimetinib For Relapsed/Refractory Solid Tumors

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The purpose of this study is to test a new drug called experimental RMC-4630 (the study drug). It will be given in combination with cobimetinib (COTELLIC®). RMC-4630 is a new experimental drug. This means that it is not approved by the FDA. The study will test different doses of RMC-4630 and cobimetinib to determine which combination of doses is safe and tolerated. This study will also test how your body processes RMC-4630 and cobimetinib when given together.

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

Experimental Combination of AMG 510 and Trametinib for Advanced Solid Tumors With KRAS p.G12C Mutation

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This research study will test the effects of an experimetnal combination therapy. Experimental AMG 510 will be given with trametinib. This combination is being tested to treat certain cancer types with a specific mutation called KRAS p.G12C. Experimetnal AMG 510 is an anticancer drug. It is being developed for tumors with a specific mutation called KRAS p.G12C. Trametinib is an anticancer drug that interferes with the growth and spread of cancer cells in the body. The purpose of this study is to learn about the safety and tolerability (effects good or bad) of the combination of AMG 510 and trametinib. This study will also look at what doses of AMG 510 and trametinib are safe for people to take. The study will be conducted in two parts: Part 1 called dose exploration and Part 2 called dose expansion. The purpose of Part 1 of the study is to find out whether certain dose levels of AMG 510 and trametinib are safe and tolerable. The purpose of Part 2 is to test the safety of the study drug combination and understand their effect on the tumor. AMG 510 is still experimental and is not approved by any regulatory health agency such as the FDA. You will also receive trametinib in this clinical trial. Trametinib is approved in USA to treat certain cancer types. However, it is not approved in combination with AMG 510.

Drug study, Phase 1
Any, age 18 to 100 years old

A Study of Experimental Combination Treatment for Relapsed, Refractory or Progressive Neuroblastoma

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With the hope of finding a new therapy for fighting the type of cancer that you have, you will receive the following drugs on this study: · Irinotecan, temozolomide, dinutuximab, and sargramostim (GM-CSF) or · Irinotecan, temozolomide, dinutuximab, and sargramostim (GM-CSF) with eflornithine (DFMO) The drugs irinotecan and temozolomide have been used to treat adults and children with different types of cancer. This drug combination has also been used in patients with relapsed/refractory cancers. This includes patients with relapsed/refractory NBL. This drug combination was well tolerated. This means it did not result in too many side effects for patients. Dinutuximab works differently than most standard chemotherapy drugs. Dinutuximab is a monoclonal antibody. Monoclonal antibodies are proteins made in the lab, designed to attach to specific targets on cancer cells. When dinutuximab attaches to NBL cells, the body’s immune system is stimulated to attack and kill the NBL cells. Dinutuximab is a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation it targets cancer cells without destroying nearby healthy cells. Dinutuximab has been given with irinotecan and temozolomide in patients with relapsed/refractory NBL. This combination was well tolerated. GM-CSF is a substance that is similar to one made by the body. Under normal circumstances, the body makes small amounts of GM-CSF. This helps it produce normal infection-fighting white blood cells. It is now possible to make GM-CSF outside of the body and give humans much higher amounts than their own bodies make. In the lab and in animals, GM-CSF increases the anti-cancer effect of monoclonal antibodies like dinutuximab. Eflornithine (DFMO) is an investigational drug that is not yet approved by the FDA for use in cancer patients. DFMO has been approved by the FDA for treatment of an infection called trypanosomiasis. DFMO blocks the production of chemicals called polyamines that are important in the growth of cancer cells. This drug has been used in adults with cancer. It has also been tested both alone and in combination with chemotherapy in children with cancer. It has been tested in children with neuroblastoma. There is some evidence that polyamines may play an important role in childhood tumors. This is especially true in tumors that depend on the abnormal activity of MYC genes (like neuroblastoma). In the laboratory, DFMO and chemotherapy are able to reduce the growth of neuroblastoma tumors. DFMO may also help the body’s immune system kill NBL cells, and may help immunotherapies like dinutuximab work better. We want to find out if giving DFMO along with dinutuximab, GM-CSF, irinotecan, and temozolomide is tolerated. We also want to see how effective the drug combination is against relapsed or refractory NBL. The overall goal of this study is to find out what effects: - DFMO given with - irinotecan, - temozolomide, and - dinutuximab has on children and young adults with relapsed or refractory NBL. In addition to the treatment goal, we would like to answer some biology research questions that might benefit future patients. We will also ask you about any pain you are having during therapy. These studies are described later in this form.

Biological study, Phase 2
Any, age 1 years or older

Experimental Inotuzumab Ozogamicin and Chemotherapy for Types of Leukemia

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The goals of this study are to study: · For High-Risk B-ALL (HR B-ALL): Whether adding experimental inotuzumab ozogamicin (InO) to standard chemotherapy maintains or improves outcomes. · For High-Risk B-ALL (HR B-ALL): Whether treating both males and females for 2 years from the start of Interim Maintenance maintains outcomes for males who have previously been treated for 3 years from the start of Interim Maintenance. · For High-Risk Favorable (HR-Fav) : To describe outcomes for patients when treated with one phase of Interim Maintenance instead of two. Also, when treating both males and females with the same duration of chemotherapy (2 years from the start of Interim Maintenance)

Drug study, Phase 3
Any, age 1 to 24 years old

Experimental Treatment with Atezolizumab in Localized Bladder Cancer

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This study will test the effects of an experimental drug called MPDL3280A (also called atezolizumab). It will be studied in patients with bladder cancer. Your body’s immune system has a natural ability to withstand tumor growth. Tumors partially resist the immune system by expressing a protein called PD-L1. Atezolizumab blocks PD-L1. It allows your immune system to better recognize and attack cancer cells. Atezolizumab is an experimental drug. This means that the FDA has not approved atezolizumab. Initial results suggest that patients whose tumors express more PD-L1 are more likely to respond to atezolizumab. However, this study is open to all patients with bladder cancer regardless of PD-L1 status. Your tumor will not be tested until after you complete treatment.

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

Experimental Erdafitinib for Relapsed/Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorder

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This is a Phase 2 study of an experimental drug called JNJ-42756493 (erdafitinib). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on your tumor or type of cancer. We are using JNJ-42756493 (erdafitinib) in this study because it has been shown to block the growth of cancer cells with changes (mutations) in the FGFR1/2/3/4 genes. These mutations help cancer cells grow in test tubes and in animals. You are eligible for this study because your tumor was found to have a mutation in one of these genes. JNJ-42756493 (erdafitinib) is considered a study drug in the treatment of your tumor or type of cancer, we do not know if it will work against the type of tumor you have. A Phase 1 study of JNJ-42756493 (erdafitinib) has been completed in adults with cancer. In the Phase 1 study, researchers determined the dose of JNJ-42756493 (erdafitinib) can be given without too many side effects. This study will be the first time that JNJ-42756494 (erdafitinib) is given to children. The dose used in this study will be based on the dose used in adults. If you have bad side effects, your dose may be decreased. The goals of this study are: The main goal is to test any good and bad effects of the study drug JNJ-42756493 (erdafitinib) on your tumor. A second goal of the study is to evaluate side effects that might be caused by JNJ-42756493 (erdafitinib). Another goal is to learn more about the pharmacology (how your body handles the drug) of JNJ-42756493 (erdafitinib)

Drug study, Phase 2
Any, age 1 to 21 years old

A Study of Experimental Radiation Therapy With Cisplatin or Cetuximab for Oropharyngeal Cancer

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Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells. They either kill the cells or stop them from dividing. Monoclonal antibodies, such as experimental cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. This study will test radiation therapy with cisplatin or cetuximab. We hope to see how well it works in treating patients with oropharyngeal cancer.

Biological study, Phase 3
Any, age 18 to 120 years old

Experimental Nab-Paclitaxel and Durvalumab With or Without Neoantigen Vaccine for Metastatic Triple Negative Breast Cancer

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This study is being done to learn about the effects (good and bad) of using an individualized vaccine. It will be given along with a drug called durvalumab and standard chemotherapy. We are comparing these effects to the effects of using durvalumab and standard chemotherapy alone. We want to find out if the individualized vaccine is better or worse than the usual approach for your metastatic triple negative breast cancer. The usual approach is defined as care most people get for metastatic triple negative breast cancer.

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