NCT05097378

Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

Perioperative Encorafinib+Binimetinib in BRAFV600 Mutant Clinically Detected AJCC Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: CCTU- Cancer Theme · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A two-arm, randomised trial investigating the response of encorafenib and binimetinib compared to standard adjuvant therapy.

Detailed description

A phase II, multi-centre, open label, randomised trial. The trial will assess the delivery, response rate, treatment compliance, efficacy and safety of encorafenib and binimetinib compared to standard adjuvant therapy in patients with BRAFV600 mutant clinically detected AJCC stage III(B/C/D) or oligometastatic stage IV Melanoma.

Conditions

• Melanoma
• Cancer

Interventions

Type	Name	Description
DRUG	Encorafenib + Binimetinib	Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor, which suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K). Binimetinib is an ATP-uncompetitive, reversible inhibitor of the kinase activity of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. Binimetinib inhibits activation of MEK by BRAF and inhibits MEK kinase activity
DRUG	Standard Adjuvant Treatment	Standard Adjuvant Treatment

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-09-01
• Completion: 2024-01-31
• First posted: 2021-10-28
• Last updated: 2021-10-28

Locations

1 site across 1 country: United Kingdom