Purpose of this Study
We are doing this study to find out if a study drug called binimetinib is a safe and effective option for cancers that harbor certain genetic mutations (RAS/RAF/MEK). We want to know how well it works on its own for some cancers, and how it works in combination with another study drug called palbociclib for other cancers.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with a form of cancer with tumor(s) that have one of the following mutations: RAS, KRAS, NRAS, HRAS, non-BRAF V600E, or rare RAF fusions.
People diagnosed with the following types of cancer will not be eligible to join: non-small cell lung cancer, colorectal cancer, and melanoma.
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
People diagnosed with the following types of cancer will not be eligible to join: non-small cell lung cancer, colorectal cancer, and melanoma.
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
This study involves 4 different participation groups. The group(s) in which you are able to participate will depend on what type of cancer you have and its mutations.
If you choose to participate and are in Group 1, you will get a random assignment (like a coin flip) to receive either binimetinib alone or in combination with palbociclib. You will get these drugs as pills you take by mouth. Binimetinib will be taken two times a day for 28 days and palbociclib will be taken once a day for 28 days.
If you choose to participate and are in Group 2, Group 3, or Group 4, you will get binimetinib and palbociclib as pills you take by mouth with binimetinib taken two times a day for 28 days and palbociclib taken once a day for 28 days.
If you choose to participate and are in Group 1, you will get a random assignment (like a coin flip) to receive either binimetinib alone or in combination with palbociclib. You will get these drugs as pills you take by mouth. Binimetinib will be taken two times a day for 28 days and palbociclib will be taken once a day for 28 days.
If you choose to participate and are in Group 2, Group 3, or Group 4, you will get binimetinib and palbociclib as pills you take by mouth with binimetinib taken two times a day for 28 days and palbociclib taken once a day for 28 days.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
EAY191-A3, A ComboMATCH Treatment Trial: Palbociclib and Binimetinib in RAS-Mutant Cancers (NCT05554367)
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00115258
NCT ID
NCT05554367
Phase
II
Enrollment Status
Open to Enrollment