This trial is evaluating whether BAY2666605 will improve 7 primary outcomes and 5 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Cycle 1, Day 1.
This trial requires 89 total participants across 2 different treatment groups
This trial involves 2 different treatments. BAY2666605 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 1 and are in the first stage of evaluation with people.
According to the American Cancer Society, there is a higher incidence of melanoma in white people as compared to non-white people (11.1 in 100,000 vs. 4.7 in 100,000). The highest age adjusted incidence rates are: 80.3 in women aged 0–14; 19.2 in women aged 45–49 years; and 25.6 in men aged 30-44. For Americans, melanoma is most common in whites (18.7% of cases), Hispanics (17.5%), non-Hispanic blacks (7.0%), and Asians (2.8%) (in contrast, Non-Hispanic whites have a significantly lower incidence (3.6% and 7.
Even though it is one of the best known cancers, most melanomas are curable, because patients often have early and well-staged melanomas at the time of diagnosis. Even in those melanomas that go unchecked, their prognosis is still far better than that of basal-cell carcinomas. However, there is no definitive cure for the disease. In most patients recurrence usually occurs within two to four years. A recent publication has shown the possible use of ipilimumab and the BRAF(V600E) mutation as biomarkers for predicting relapse. More work is required in this area.
While melanoma is most commonly found in Caucasians, it is also prevalent in some ethnic minorities. In most cases, melanoma is a multifocal tumour in the affected person and is most often noticed by locals when a new mole appears. There is no real cure for melanoma; the only realistic method of prevention is to identify and remove the moles that pose a risk to the person.
Melanoma can be treated with surgery and adjuvant therapy. Surgical treatment is often the initial treatment of choice, whereas adjuvant therapy may add time to the cure, depending on the stage of the tumour and the patient's overall condition. The decision about how to best treat an individual patient needs to take into account the stage of the disease, the patient's overall condition and the preferences of the patient.
Melanoma is a rare type of skin cancer. In the year 2012, there were almost 100,000 new cases. In the USA, it is about 12,000 new cases. Most of these occur in people over the age of 50 and more than half occur in people under the age of 20. Females make up close to half of all cases with men more often presenting with metastasis and greater tumour burden at diagnosis. The most common sites of metastasis are the brain, lymph nodes, liver, and bone marrow. Melanoma is relatively common in Australia, America, and New Zealand, where there is strong seasonal variation in incidence. The disease is thought to be more common after age 40.
The main signs of melanoma include the primary tumour spreading and metastasis. Primary tumour spreading and metastasis can be easily detected from a clinical examination. It is also possible to recognise the signs of melanoma by means of a biopsy. Primary tumour spreading and metastatic dissemination of the melanoma can be more efficiently evaluated by CT scans, MRIs and PET-CRs.
There are still many hurdles in treating melanoma patients in this regard. Some of the newly reported treatments require further evaluation for their effectiveness. Nevertheless, it is clear that a major impact in curing and prolonging the patient’s life has come from the development in various fields such as genetics, molecular biology, targeted treatment and immunotherapy. Some of the newer approaches for melanoma treatment may provide better outcome even in advanced stages of the disease. This might encourage patients and their families to be further involved in their treatment and management.
The chances of developing melanoma for people of varying ages are shown in the accompanying table. When the chances of developing melanoma are combined with the average number of cancers diagnosed yearly in different countries, the chances of developing melanoma are roughly quantified. The chances are fairly low for individuals whose parents had cancer. However, the chances of having melanoma for people whose siblings also had cancer are quite substantial. The higher the risk of having a cancer family history, the greater is the chance that the person will develop this disease. It is therefore important to learn the existence of such a family member and consider the possibility of his or her own risk of cancer. Melanoma risk also increases with gender and sun exposure.
Bay2666605 is well tolerated by patients with metastatic or unresectable melanoma. While pain was commonly reported as the most important dose-related side effect, the study was not powered to detect a change in quality of life. A larger study with clinically relevant outcome measures is required to further evaluate the potential benefits of this targeted treatment.
Patients taking oral BAY2666605 experienced lower mean PSA progression rates when compared to patients taking a placebo. PSA progression was also significantly lower (p<0.0001) in patients randomized to BAY2666605 compared with the placebo.
Bay2666605 has an antimetastatic effect by decreasing VEGF expression in human cells and by decreasing the formation of metastatic foci in a nonhuman xenograft model.