NRG, EAY191-N4, Ph2, Open-label,Ovarian and Endometrial Cancers, Selumetinib vs Selumetinib+Olaparib

What is the Purpose of this Study?

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.


Eligibility

  • * Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N4 based on the presence of an actionable mutation as defined in EAY191
  • * Patients must be enrolled on the ComboMATCH Master Registration Trial EAY191
  • * Patients must have RAS pathway mutations as determined by the ComboMATCH screening assessment
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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Garrett Crook

More about this Clinical Trial

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

Study Details
Disease Type/Condition

Corpus Uteri, Ovary

Principal Investigator

Taylor, Kristin

Co-Investigators

Bobbie Jo Rimel, Margaret Liang

Age Group

Adult

Phase

II

IRB Number

STUDY00003806

ClinicalTrials.gov ID

NCT05554328

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Garrett Crook

Email
Garrett.Crook@cshs.org
Study Detail
Disease Type/Condition

Corpus Uteri, Ovary

Principal Investigator

Taylor, Kristin

Age Group

Adult

Phase

II

IRB Number

EAY191-N4

ClinicalTrials.gov ID

NCT05554328

Key Eligibility
ClinicalTrials.gov

Contact
Name

Garrett Crook

Email
Garrett.Crook@cshs.org