This trial is evaluating whether Atezolizumab will improve 1 primary outcome and 13 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cy 1 and 4 (1 Cy = 28 days).
This trial requires 514 total participants across 2 different treatment groups
This trial involves 2 different treatments. Atezolizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Patient-centred, psychosocial and supportive care is frequently utilized in the treatment of melanoma. It is very important to incorporate these treatments into the multidisciplinary treatment of the disease.
Melanoma is a type of cancer that begins in the melanocytes of the skin. In many cases, it is not detected until it has invaded neighboring tissue, spread to other sites in the body, or has metastasized to local lymph nodes.\n
Melanoma is one of the most common skin cancers, and its incidence continues to rise in North America and Europe. Melanoma develops from melanocytes, and a mutation and a single growth stimulus can result in nevi (benign, borderline and [malignant melanoma](https://www.withpower.com/clinical-trials/malignant-melanoma)), which can spread to the skin and become metastasising tumors (melanoma). The most important risk factors for melanoma, in terms of the number of deaths, are: (i) age; (ii) occupation, e.g., in agricultural workers and exposure to chemicals in the workplace; (iii) skin colour; and (iv) gender.
The prevalence of melanoma is declining over time, possibly because of increased awareness among the general public of melanoma risks associated with exposure to UV radiation. Results from a recent paper confirms a higher prevalence of melanoma in some populations than others, as do studies conducted elsewhere.
Some signs of melanoma include moles that tend to grow quickly, itch, change in color, or may bleed. In some cases melanoma may be evident as an invasive tumor that looks like [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer). These signs may be present long before the cancer can even be diagnosed.
The evidence in the current literature does not support a causal connection of metastatic melanoma with any of the treatments listed herein, and in particular no evidence has shown a cure for metastatic melanoma. The only available evidence of efficacy is in the prevention setting as reported in a previous literature review. For this reason, we recommend that melanoma patients with metastatic disease and suitable for a systemic treatment, or those who are in remission for more than 6 months, should be offered adjuvant therapy with a curative intent.
Atezolizumab was well tolerated, with no life-threatening or very serious allergic reactions reported and no fatalities were reported. Side effects were more common to other immune checkpoint inhibitors but were in general tolerable. No treatment interruptions by the patient was reported at this dose.
Among all SAEs, skin reactions appear to occur in roughly the same frequency as those described in the clinical trials of the first-line treatment of metastatic renal cell carcinoma (33 vs 40%). The most common side effects were rash, swelling, pruritus, dyspnoea, and fatigue.
At this time, there are only one or two ongoing clinical trials ongoing for this agent. These trials are either comparing it with interleukin-2 or interferon-α. Although the results are awaited, the safety profile and the efficacy of atezolizumab are comparable to those of other T-cell-based agents.
If the age is known, then the risks may change. For example, the risks of metastasizing melanoma are highest before 60 years of age. This may change how treatment options are viewed by treatment specialists, as it is known that older people have longer lifespans and are therefore more likely to live for the treatment. The average age of diagnosis differs by type of skin cancer. The average age of diagnosis in North America is about the age of 40. For people in the United Kingdom and Australia an average age of diagnosis is between 50 and 60 (see “Distribution” below). In the United States, the average age of diagnosis is about 60 years for melanoma.
Although melanoma is curable, it represents the deadliest type of cancer in some high-income, densely populated countries. In Australia and New Zealand, melanoma is the ninth-most common form of cancer in women and the fourth-most common in men. More than half of melanoma cases develop on areas of the skin formerly exposed to the sun, suggesting that a lifestyle factor such as excessive sun exposure is a leading risk factor for melanoma. In the US, melanoma is the second-most-common cancer among women after breast cancer.
Survival from melanoma is low. Some of the treatment decisions that are made, or not made, are based on how far metastatic melanoma has spread when it is diagnosed. Survival has improved dramatically in recent years with early detection of melanoma patients and improved treatment options.