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

Pfizer

Status and phase: Completed; Phase 2

Conditions: BRAF or NRAS Mutant Metastatic Melanoma

Treatments: Drug: MEK162

Study type: Interventional

Funder types: Industry

Identifiers

NCT01320085

CMEK162X2201

2010-023412-13 (EudraCT Number)

C4211001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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183 participants in 3 patient groups

BRAFV600 mutant, 45mg bid MEK162

Experimental group

Description:

BRAFV600 mutant, 45mg bid MEK162

Treatment:

Drug: MEK162

NRAS mutant, 45mg bid MEK162

Experimental group

Description:

NRAS mutant, 45mg bid MEK162

Treatment:

Drug: MEK162

BRAFV600 mutant, 60mg bid MEK162

Experimental group

Description:

BRAFV600 mutant, 60mg bid MEK162

Treatment:

Drug: MEK162