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Trial Summary


Protocol No.EA6134
StatusOPEN TO ACCRUAL
Principal InvestigatorLogan, Theodore
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Randomized Phase III trial of Dabrafenib + Trametinib followed by Ipilimumab + Nivolumuab at Progression vs. Ipilimumab + Nivolumab followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFFV600 Mutant Melanoma
DescriptionThis randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Patients must have unresectable stage III or stage IV disease
  • Patients must not have evidence of interstitial lung disease or pneumonitis
  • Patients must not have history of retinal vein occlusion (RVO)
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesMelanoma
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu