Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma

  • End date
    Mar 31, 2025
  • participants needed
  • sponsor
    University of California, San Francisco
Updated on 28 December 2021


This phase II trial studies how well binimetinib and imatinib work in treating patients with stage III-IV KIT-mutant melanoma that cannot be removed by surgery (unresectable). Binimetinib and imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and imatinib may help treat patients with KIT-mutant melanoma.



I. To evaluate the overall response rate (ORR) of binimetinib plus imatinib in patients with advanced KIT-mutant melanoma.


I. To determine the safety and tolerability of binimetinib plus imatinib in patients with advanced KIT-mutant melanoma.

II. To estimate efficacy and survival parameters in patients with advanced KIT-mutant melanoma treated with binimetinib plus imatinib.

III. To estimate efficacy in patients with advanced KIT-mutant melanoma treated with binimetinib plus imatinib.


I. To investigate association between changes in drug phosphorylated end products (p-KIT, p-MEK, p-ERK) and clinical response.

II. To investigate association between clinical response and baseline Neurofibromatosis 1 (NF1) and SPRED1 status.

III. To investigate pathologic correlates of acquired resistance. IV. To investigate whether NF1 and SPRED1 loss contribute to acquired resistance.

V. To generate patient-derived xenograft models. VI. To determine the relationship between clinical outcomes and clinicopathologic features including KIT exon mutated, melanoma subtype, melanoma primary site, race/ethnicity, prior treatment history including immune checkpoint inhibitor (ICI)-experienced versus (vs) - naive.


Patients receive binimetinib orally (PO) twice daily (BID) on days 1-28 and imatinib PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at day 30 and 100, and then every 3 months.

Condition Melanoma Stage III, Melanoma Stage IV
Treatment Imatinib, Binimetinib
Clinical Study IdentifierNCT04598009
SponsorUniversity of California, San Francisco
Last Modified on28 December 2021


How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note