Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Conditions

• BRAF V600E-mutant Metastatic Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Encorafenib — DRUG
  Orally, once daily.
• Binimetinib — DRUG
  Orally, twice daily.
• Cetuximab — DRUG
  Standard of care.
• Irinotecan — DRUG
  Standard of care.
• Folinic Acid — DRUG
  Standard of care.
• 5-Fluorouracil — DRUG
  Standard of care.

Study Details

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

Key Dates

Start date

Oct 13, 2016

Status verified

Dec 2023

Primary completion

Feb 11, 2019

Completion

Nov 10, 2022

Study Design

Enrollment

702 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead-in, Triplet Arm
  Encorafenib + binimetinib + cetuximab.
• Experimental: Doublet Arm
  Encorafenib + cetuximab.
• Active Comparator: Control Arm
  Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.

Primary Outcome Measure

(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]

Locations (90)

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