A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With Ono Pharmaceutical Co., Ltd., Merck KGaA, Darmstadt, Germany, Eli Lilly and Company.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
841actual
Sites
272
Countries
Argentina, Australia, Belgium +26
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2020-12-21 | actual | When the study began enrolling |
| Primary completion | 2025-03-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-28 | estimated | The whole study's end, after follow-up |
| First posted | 2020-10-29 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-11 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Neoplasms
Interventions
- Drug: Encorafenib — also filed as Braftovi, PF-07263896, LGX818, ONO-7702
- Drug: Cetuximab — also filed as Erbitux
- Drug: Oxaliplatin — also filed as Eloxatin
- Drug: Irinotecan — also filed as Campostar
- Drug: Leucovorin — also filed as Wellcovorin, Fusilev, Khapzory
- Drug: 5-FU — also filed as Fluorouracil
- Drug: Capecitabine — also filed as Xeloda
- Drug: Bevacizumab — also filed as Zirabev
Primary outcomes
what the primary-completion date above is the date OFSLI: Number of Participants With Dose Limiting Toxicity (DLTs)
measured Cycle 1 (28 days)
Phase 3: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) for Arm B vs Arm C - FAS
measured From date of randomization to earliest documentation of PD by BICR or death or censoring date, whichever occurred first (maximum up to 37.25 months)
Phase 3: Objective Response Rate (ORR) as Assessed by BICR for Arm B vs Arm C - FAS ORR Subset
measured From date of randomization to until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 24.71 months)
Cohort 3: ORR as Assessed by BICR for Arm D vs Arm E - FAS
measured From date of randomization until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 14.1 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-05-31 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-05-07 · 2.8 MB · SAP_001.pdf
Publications
- PMID 41230651 — linked by the registry
- PMID 40444708 — linked by the registry
- PMID 39863775 — linked by the registry
- PMID 36763936 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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