BVD-523 for Melanoma
This study is evaluating whether a targeted therapy called BVD-523 is effective in treating advanced uveal melanoma.
See full descriptionAbout the trial for Melanoma
Treatment Groups
This trial involves 2 different treatments. BVD-523 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Side Effect Profile for Dose-escalation 10mg b.i.d. Cohort
Eligibility
This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether BVD-523 will improve 1 primary outcome and 9 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Between the dates of the start of trial treatment and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment. up to 52 weeks.
Who is running the study
Principal InvestigatorPatient Q & A Section
What causes melanoma?
The cause of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is complex and includes solar cell-generated ultraviolet rays, sun exposure, and lifestyle factors. Melanoma is a heterogeneous type of cancer, which has at least 14 distinct genetic and morphologic variants. Melanoma can arise spontaneously and from a broad spectrum of nevi. Sunscreen is the best prevention strategy for mitigating sun exposure, but melanoma also can be prevented by careful use of sunscreens with high UVA protection.
What are the signs of melanoma?
Melanosis is the most important sign for melanoma as it occurs on most of the skin. Other signs include: itch, ulceration, pain and swelling. Some forms of melanoma such as atypical and acral lentiginous melanoma can produce only a few of these symptoms. The most important aspect is if it is a persistent abnormality, such as red lesions which have never gone away or a new lesion. Tumours that are growing should be removed as soon as they are diagnosed. If a tumour is removed but the margins are not clear, they should hopefully be checked annually and surgery is not warranted. If a tumour is suspected but not diagnosed, then a biopsy should be performed.
How many people get melanoma a year in the United States?
The American Cancer Society estimates that 441,300 new cases of melanoma will be diagnosed in 2017 and 452,800 cases of melanoma will be diagnosed in 2022. The U.S. lifetime risk of developing melanoma is about 1.4%. Because melanomas are very difficult to detect prior to being symptomatic, and melanomas are very often symptomatic before detection, people who receive a diagnosis of melanoma must be vigilant and have a plan of surveillance for future [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), regardless of type or localization of the initial cancer.
What are common treatments for melanoma?
The most common treatment for melanoma is surgical excision. Noninvasive techniques can have a significant impact on the cancer. However, for certain melanomas, such as those with a mole with minimal or no pigmentation at the time of surgery, these techniques may not always be effective. Radiation therapy can be used for inoperable melanomas, when surgery is not practical or the patient would not consider it, or if all treatment options are exhausted.
Can melanoma be cured?
Although melanoma is a highly curable disease, a cure is not possible. There is no cure for nonmelanoma skin cancer, and most skin cancers are curable by excision or treatment.
What is the survival rate for melanoma?
Overall survival is good, with an average survival rate of about 24 months from the time of diagnosis of melanoma; however, the outlook of patients diagnosed with node-negative melanoma is often less favourable. The survival rate decreases with older age at presentation and with disease spread. As a general rule, the five-year survival rate of cutaneous melanoma does not differ significantly from that for non-cutaneous melanoma.
Does melanoma run in families?
Genetic linkage analysis has provided compelling empirical evidence in support of an autosomal dominant genetic basis for melanoma susceptibility in these families. Genetic markers associated with familial melanoma susceptibility include the MC1R and the CDKN2A genes.
Is bvd-523 typically used in combination with any other treatments?
BVD-523 was used in combination with all 3 treatments and the authors did not observe significant additional antitumor activity. BVD-523 was used in combination with all of the 2 treatments, and no additional antitumor activity was observed. BVD-523 was tested in combination with all 3 treatments, and there were no additional antitumor effects. As the activity of BVD-523 has no additive effects and the side effects in combination with all 3 treatments were tolerable, these results provide a starting point for further evaluation in a phase 1 trial of BVD-523 in patients with BRCA mutation carriers who have not responded to treatment. Further evaluation of BVD-523 is warranted.
How serious can melanoma be?
Melanoma is not unheard of, and for many patients can be a cause for great discomfort and concern. However, the incidence of melanoma is not as high as commonly thought and does not necessarily signify that a patient will have a more serious or dangerous diagnosis.
What does bvd-523 usually treat?
B-CD20 monoclonal antibody therapies have not led to a marked increase in the clinical use of melphalan as an induction agent compared to B-CD23 treatments alone for treatment of relapsed, refractory CD20 expressing B-cell malignancies. These preliminary findings are in agreement with the data from other oncology centers. We believe that further clinical studies need to demonstrate the benefit of including B-CD20 in induction regimens of CD20 targeted agents.
What is the primary cause of melanoma?
The main contributor of melanoma to the overall cancers burden is ultraviolet (UV) radiation from the sun. The most consistent and powerful risk factor for melanoma in developed countries is sun exposure over a long period of time such as on the beach, in the summer or at work. Although most people know about the benefits of avoiding UV exposure, people exposed to very high levels of UV radiation daily over a short period of time are at the highest risk for developing melanoma. Melanoma has a higher mortality rate than non-melanoma skin cancer and is the most costly cancer from treatment.