NCT04390243

Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation

BrafPanc: A Phase II Trial of Binimetinib in Combination With Encorafenib in Patients With Pancreatic Malignancies and a Somatic BRAFV600E Mutation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.

Detailed description

PRIMARY OBJECTIVE: I. To determine the efficacy of the combination of binimetinib and encorafenib as \>= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation. SECONDARY OBJECTIVES: I. To determine in patients treated with the combination of binimetinib and encorafenib as \>= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation: Ia. The median progression-free survival. Ib. The median overall survival. Ic. Duration of response. Id. Time to response. Ie. The safety and tolerability. OUTLINE: Patients receive encorafenib orally (PO) once daily (QD) and binimetinib PO twice daily (BID) on days 1-25. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Conditions

• Locally Advanced Pancreatic Carcinoma
• Metastatic Pancreatic Carcinoma
• Recurrent Pancreatic Carcinoma
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Binimetinib	Given PO
DRUG	Encorafenib	Given PO

Timeline

• Start date: 2020-11-16
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2020-05-15
• Last updated: 2024-05-06
• Results posted: 2024-01-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study