A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma

• Status: Active, not recruiting
• Trial end date: 2021-06-29
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety and efficacy of single-agent MEK162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring BRAFV600E or NRAS mutations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma; Pfizer

Criteria

Inclusion Criteria:

• Locally advanced or metastatic cutaneous melanoma AJCC Stage IIIB to IV, not potentially curable with surgery

• BRAF or NRAS mutation in tumor tissue

• All patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of BRAF or NRAS mutations and the additional analyses described in the protocol

• Evidence of measurable tumor disease as per RECIST

• WHO performance status of 0-2

• Adequate organ function and laboratory parameters

Exclusion Criteria:

• History or evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or any eye condition that would be considered a risk factor for CSR or RVO

• Patients with unstable CNS metastasis

• Prior treatment with a MEK- inhibitor

• Impaired cardiovascular function

• HIV, active Hepatitis B, and/or active Hepatitis C infection

• Pregnant or nursing (lactating) women

• Women of child-bearing potential UNLESS they comply with protocol contraceptive requirements

Other protocol-defined inclusion/exclusion criteria may apply.