1.1 Primary Objective 1.1.1 Cohort 1: Compare progression free survival of combination of olaparib and selumetinib to selumetinib alone in patients with RAS mutant ovarian cancer. 1.1.2 Cohort 2: Compare progression free survival of combination of olaparib and selumetinib to selumetinib alone in patients with RAS mutant endometrial cancer. 1.2 Secondary Objectives (both cohorts) 1.2.1 Determine safety of both arms per CTCAE v5.0. 1.2.2 Compare objective response rate per RECIST 1.1 between the two arms. 1.2.3 Determine rate of objective response per RECIST 1.1 in those patients that crossover from the single agent arm to the combination arm. 1.2.4 Report duration of response of the two treatment arms. 1.2.5 Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment ctDNA mutation profile from plasma, as described in ComboMATCH Registration Protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH Registration Protocol. 1.3 Translational Objectives (both cohorts) 1.3.1 To assess association of baseline genomic and transcriptomic status with response and resistance to therapy.
What is the full name of this clinical trial?
EAY191-N4: A randomized trial of Selumetinib and Olaparib or Selumetinib alone in patients with recurrent or persistent RAS pathway mutant ovarian and endometrial cancers