At a glance
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An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation
In Brief
A Phase 2 clinical trial evaluating binimetinib, nivolumab, and 1 other intervention for MSS and RAS-mutant Colorectal Cancer. Completed, enrolled 75 participants across 50 sites in 5 countries.
Detailed Summary
This is a multicenter, open-label, Phase 1B/2 study to evaluate the safety and assess the preliminary anti-tumor activity of binimetinib administered in combination with nivolumab or nivolumab + ipilimumab in adult patients with advanced metastatic colorectal cancer (mCRC) with microsatellite stable (MSS) disease and presence of a RAS mutation that have received at least one prior line of therapy and no more than 2 prior lines of therapy. The study contains a Phase 1b period to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and schedule of binimetinib followed by a randomized Phase 2 period to assess the efficacy of the combinations.
Study Details
Timeline
Interventions
Orally, twice daily.
Intravenously (IV) every 4 weeks (Q4W)
intravenously (IV) every 8 weeks (Q8W)