encorafenib
encorafenib: developed by 1 company · 14 clinical trials tracked · 1 FDA decision.
encorafenib evidence translation
What we can confirm
1 FDA record · 14 tracked trials
What it means
What to watch
Prepared research question
How could encorafenib → ARRY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 6 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| ARRAY BIOPHARMA INC (ARRY) unresectable or metastatic melanoma with a BRAF V600E or BRA… | Approved |
Clinical Trials (14)showing 10 most recent
ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer
Primary endpoint: safety and adverse events (AEs)
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
Primary endpoint: Progression-free survival (PFS)
A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E Metastatic Colorectal Cancer
Primary endpoint: Maximum tolerated dose (dose escalation cohort)
Phase 1b/2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma
Primary endpoint: Response rate defined as Partial Response (PR) + Complete Response (CR) using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria of all measurable target lesions present at the time of enrollment on trial.
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
Primary endpoint: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer
Primary endpoint: Circulating tumor deoxyribonucleic acid (ctDNA) clearance rate (Phase II; ctDNA positive cohort)
A Phase 1/2, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer
Primary endpoint: Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs)
A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER
Primary endpoint: Progression-free Survival (PFS)
A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
Primary endpoint: Percentage of Patients Experiencing Dose Limiting Toxicities
A Phase II Neoadjuvant Study of Encorafenib With Binimetinib in Patients With Resectable Locoregional Metastases From Cutaneous or Unknown Primary Melanoma (Stages III N1B/C/D)
Primary endpoint: Pathologic Complete Response
FDA Decisions1 records
Frequently asked questions
Who is developing encorafenib?
encorafenib is being developed by ARRAY BIOPHARMA INC.
How many clinical trials involve encorafenib?
BioSniper tracks 14 clinical trials involving encorafenib.
What is encorafenib's latest FDA decision?
The most recent tracked FDA decision for encorafenib is Approval for 1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test. ( 1.1 , 2.1 ) Colorectal Cancer (CRC) • in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorize, dated June 27, 2018.