Skin Cancer/Melanoma clinical trials at UC Irvine

This phase II/III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

This study is for women with breast cancer and for adults with melanoma. Breast cancer is a type of cancer when cells in the breast turn into cancer cells, which may grow out of control. Melanoma is a type of skin cancer that starts in cells called melanocytes. These cells make a substance called melanin which gives the skin its color. In this study, people will have surgery to remove the lymph node closest to the site of their cancer. This lymph node is called the sentinel node. This is done to check if the cancer has spread from the original site to the sentinel node. This procedure is called a sentinel node biopsy. This study will provide more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 may help to show the lymph nodes more clearly during surgery. This will help the surgeon find the lymph node closest to the site of the cancer (sentinel node). The main aim of the study is to find the best dose of ASP5354 that clearly shows the lymph nodes during surgery. This is an open-label study. That means each person in the study and the study doctors knew that person received ASP5354. Each person will only receive 1 dose of ASP5354. This dose will consist of 2 to 4 injections of ASP5354 around the cancer site. Small groups of people will each receive a different dose of ASP5354. The first group will receive a low dose of ASP5354. If the lymph nodes are clearly seen, the next group will receive a lower dose of ASP5354 and the following group will receive a dose of ASP5354 that is higher than the dose the first group received. Then, the results will be checked by an independent panel of experts. Depending on the results, the next groups may start on the current doses of ASP5354 or may receive a higher dose. In this study, up to 6 doses of ASP5354 may be given, but each person only receives 1 of these doses. People that want to take part in the study will be checked by a study doctor. This will be on a separate visit before their surgery. Before surgery, people who take part in the study will be asked if they have any other medical problems. They will have a physical exam, an ECG to check their heart rhythm, and have their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks will include some blood and urine samples taken for laboratory tests. During surgery, a study surgeon will inject ASP5354 near the cancer site. They will record how clearly they can see the lymph nodes. Some blood samples will be taken for laboratory tests and an ECG will be done. After their surgery, people will be asked if they have any other medical problems. People will return to the hospital 9 days later for a check-up. The check-up will include a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate). Other checks will include some blood samples taken for laboratory tests. People will be asked if they have any medical problems and asked to complete a feedback survey.

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and nivolumab may work better compared to usual treatments in treating patients with lymphomas or non-melanoma skin cancers.

UV1 is a therapeutic cancer vaccine that has been explored in prostate, lung cancer, in combination with ipilimumab in malignant melanoma and in combination with pembrolizumab in metastatic melanoma. This study will explore the Efficacy and Safety of UV1 administered with GM-CSF in combination with nivolumab and ipilimumab.

The purpose of this study is to calculate the sensitivity and specificity of a novel imaging device and associated software algorithm in detecting early stage melanoma versus nevi of the skin. The instrument, which was invented by the PI, for the purposes of this study, will be loaned to three external (to Rockefeller) institutions and used on patients who are scheduled for biopsy of pigmented lesions. The purpose of correlating the output screening result of the novel device and the output diagnosis of the gold standard histology analysis procedure is so that these two diagnoses can be compared to generate the number of true positives, true negatives, false positives and false negatives for the novel device. The purpose of disseminating the device to the external institutions is to achieve the appropriate power such that the specificity can be evaluated at 99% sensitivity. The rationale for the power needed in the study is that in order to be clinically useful, the device needs to be extremely sensitive (i.e. 99%) because false negative diagnosis is a dangerous situation, leading to potential progression of melanoma, the most deadly form of skin cancer.