ECOG-ACRIN Opens an Exciting New Study to Determine the Optimal Sequencing of Different Treatments in Patients With Advanced Melanoma and the BRAFV600 Mutation
The ECOG-ACRIN Cancer Research Group recently announced that a new phase 3 clinical trial in patients with melanoma and the BRAFV600 mutation is open for enrollment. The aim of this study is to determine which of two treatment sequences provides patients with the best outcome.
In both of the two treatment sequences in this study, patients will receive two drugs given in combination. The two immunotherapies that will be used in combination in one treatment sequence cause the immune system to attack tumor cells. The two drugs that will be used in the other treatment sequence work by blocking molecular pathways that drive the growth and survival of tumor cells. In previous studies, both drug combinations have been shown to be effective in patients with advanced melanoma.
In this study, EA6134, half of patients will be randomized to ipilimumab and nivolumab, given together. Both of these immunotherapies are FDA-approved. If the patient’s disease becomes worse, a different treatment combination, consisting of dabrafenib and trametinib, will then be given. This drug combination is also FDA-approved. The other half of patients in the study will be randomized to the same treatments but with the treatment sequence reversed.
A total of 300 adult men and women with advanced melanoma that has metastasized (spread beyond its local area) and cannot be surgically removed will be enrolled. Patients can potentially cross over and receive the other treatment regimen. Melanoma can be highly aggressive, and treatment often stops working, so this crossover option is important because the alternative treatment will be available for these patients. Although patients with advanced melanoma and their physicians may find themselves with numerous treatment options, few answers are available to questions about how and when to use these treatments.
In this study, patients will be given ipilimumab plus nivolumab for a maximum of 2 years, and dabrafenib plus trametinib for as long as this combination controls tumor growth. Patients will be followed for as long as they are on treatment and for up to 5 years after they complete treatment.
Because understanding treatment from the patient perspective is a priority for researchers in the ECOG-ACRIN Cancer Control and Outcomes Program, patients will be asked to report on their experiences with the two treatment regimens using standardized questionnaires. Collection of this information will allow researchers to document the full range of associated side effects and symptoms.
Information on the EA6134 clinical trial is posted on the ECOG-ACRIN Web site at http://ecog-acrin.org/clinical-trials/ea6134-educational-materials or at https://clinicaltrials.gov/ct2/results?term=EA6134&Search=Search and is continually updated. The ECOG-ACRIN Cancer Research Group, a scientific organization that designs and conducts cancer research in adults, is composed of nearly 1100 member institutions in the United States and worldwide.
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