This trial is evaluating whether RO7198457 will improve 1 primary outcome and 9 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Baseline up to 90 days after the final dose of study drug (up to approximately 27 months).
This trial requires 131 total participants across 3 different treatment groups
This trial involves 3 different treatments. RO7198457 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
The number of people diagnosed with melanoma per year is about 10/100,000. The US incidence rate of melanoma is similar to, but much higher than, the incidence rate reported for Europe. There is no clear evidence that incidence of melanoma in the United States is increasing at a faster rate than in Europe.
Melanoma cannot be related to any factor of the external environment such as UV radiation. Rather, it is a disease of aging with a probability of occurrence around the 70 year mark in the UK.
The most common treatment for melanoma is the surgical removal of the tumour. Most other cancers are typically treated through chemotherapy, surgery, and radiotherapy. These therapies are often effective and can extend survival. However, in recent years they have been shown to increase the risk of dying from cancer and are often contraindicated in patients with poor prognosis. The use of targeted therapy has shown promise in treating advanced-stage melanoma, particularly when used in combination with surgery. This trial is evaluating the effectiveness of this approach as a first line treatment against metastatic melanoma.
Melanoma is an extremely treatable disease. It is the most curable form of skin cancer, and early detection can prevent it. When melanoma is detected in its early stages, it can be treated with surgery with minimal chance of recurrence. In more advanced stages, many treatments are used, with varying success rates. Early detection of melanoma is a key component in saving a patient's life.
The most popular melanoma is a form of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), known as a melanoma, and it has been known to be a form of cancer for more than 1,000 years. The first treatment for skin cancer included the use of cauterization which was practiced many centuries ago. The goal was to clear/cure the skin cancer and prevent it from returning. In modern times, the goal is more focused on treating symptoms and decreasing the number of new patients. Despite advancements in diagnosis, treatment, and prognosis, the cure rate for melanoma is limited, and this disease is the cause of much pain and fear due to its high death rate, especially among young patients.
Melanoma is the only cancer, apart from lung, breast and skin types, that occurs in people with non-Jewish European origins. Melanoma occurs more often in men. It occurs in most countries, but presents in the elderly. Its occurrence is associated with high solar exposure. Melanomas have been found in all races, but their occurrence depends on genetic factors. Melanoma is a heterogeneous disease. The vast majority of cases occur in dark-skinned populations of the Americas. Melanoma can be prevented by physical avoidance of high-brightness sun exposure.
Common side effects included itchiness, itchiness or burning sensation at the injection site, and itching or burning sensations in the ears, mouth, or throat. Side effects are usually mild and only occur at dose levels greater than or equal to 0.5 mg in a single injection. Side effects are transient and disappear when treatment ends. There are no dose-related side effects.
The drug has a high level of safety even if administered to people up to the age of 75 years. The dose used in the safety studies was not related to the level of exposure expected in clinical use. There are currently no restrictions on the use of ro7198457 in people, however as the trial was only a phase IIb study, no recommendation on the use of ro7198457 for the treatment of melanoma has been made.
Overall, ro7198457 reduced cell viability by inhibiting STAT3 phosphorylation, down regulation of PI3K and P-Akt and upregulation of p21 expression. These effects were observed only in melanoma cells but not in healthy control cells.
There are several forms of melanoma that have been found to be insensitive or resistant to ro7198457 so the right candidate might not be out there but the right combination might be.
The data available so far suggests that ro07198457 has activity as a single agent against TIG-3 tumors, and that ro07198457, when combined with chemotherapy, shows promise in combating a previously resistant TIG-3 model.
Ro7198457 is a novel small molecule which can block the VEGF receptor and inhibit blood vessel formation. It can inhibit vascular endothelial growth factor receptor signaling and tumour growth and reduces intraocular neovascularisation in diabetic rats. It has been granted orphan drug status by the European Medicines Agency, is in Phase 1 clinical trials with a start date of 15 January 2015, and is being developed by Aridis Therapeutics.