Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

  • STATUS
    Recruiting
  • End date
    Dec 13, 2027
  • participants needed
    460
  • sponsor
    Revolution Medicines, Inc.
Send
Updated on 13 February 2025
See if I qualify

Summary

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.

Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Details
Condition Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
Age 18years or above
Clinical Study IdentifierNCT06625320
SponsorRevolution Medicines, Inc.
Last Modified on13 February 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

At least 18 years old and has provided informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed PDAC with metastatic disease
Measurable disease per RECIST 1.1
Adequate organ function (bone marrow, liver, kidney, coagulation)
Documented RAS mutation status, either mutant or wild-type. Eligible RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61)
Able to take oral medications

Exclusion Criteria

Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors)
History of or known central nervous system metastatic disease
Any conditions that may affect the ability to take or absorb study treatment
Major surgery within 4 weeks prior to randomization
Patient is unable or unwilling to comply with protocol-required study visits or procedures
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
US Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

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