Purpose of this Study
We are doing this study to compare the outcomes for women who use selumetinib alone and women who use selumetinib plus olaparib to treat endometrial or ovarian cancer. We want to know which option is better for women whose tumors harbor a mutation in a key survival pathway called KRAS.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with ovarian, primary peritoneal, fallopian tube, or endometrial cancer</li>
<li>Have documented RAS pathway mutations</li>
<li>Are able to have a safe biopsy of their tumor(s) performed or have a biopsy that was done in the last 12 months that confirms tumor mutations</li>
<li>Have disease that has returned after treatment or is not responding to treatment</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>Are diagnosed with ovarian, primary peritoneal, fallopian tube, or endometrial cancer</li>
<li>Have documented RAS pathway mutations</li>
<li>Are able to have a safe biopsy of their tumor(s) performed or have a biopsy that was done in the last 12 months that confirms tumor mutations</li>
<li>Have disease that has returned after treatment or is not responding to treatment</li></ul>
For more information about this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:<ul>
<li>Group 1 will get a regimen of selumetinib and olaparib</li>
<li>Group 2 will get a regimen of selumetinib alone</li></ul>
<li>Group 1 will get a regimen of selumetinib and olaparib</li>
<li>Group 2 will get a regimen of selumetinib alone</li></ul>
Study Details
Full Title
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 A ComboMATCH Treatment Trial
Principal Investigator
Angeles
Secord
Protocol Number
PRO00114076
NCT ID
NCT05554328
Phase
II
Enrollment Status
Open to Enrollment