NCT03271047

Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• MSS
• RAS-mutant Colorectal Cancer

Interventions

Type	Name	Description
DRUG	binimetinib	Orally, twice daily.
DRUG	nivolumab	Intravenously (IV) every 4 weeks (Q4W)
DRUG	ipilimumab	intravenously (IV) every 8 weeks (Q8W)

Timeline

• Start date: 2017-10-18
• Primary completion: 2020-10-13
• Completion: 2021-02-25
• First posted: 2017-09-01
• Last updated: 2022-01-04
• Results posted: 2021-11-02

Locations

50 sites across 5 countries: United States, Belgium, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study