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

Completed · Phase 2

Conditions studied: BRAF or NRAS Mutant Metastatic Melanoma

In brief

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.

Key facts

Study ID

NCT01320085

Run by

Pfizer

People needed

183

Starts

2011-03-24

Expected to finish

2023-02-06

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
• OHSU Knight Cancer Institute — Portland, Oregon, United States
• OHSU Center for Health and Healing — Portland, Oregon, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Cancer Care Associates Medical Oncology — Allentown, Pennsylvania, United States
• St. Luke's Cancer Center - Allentown Campus — Allentown, Pennsylvania, United States
• Cancer Care Associates Medical Oncology — Bethlehem, Pennsylvania, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• St. Luke's Hospital - Quakertown Campus — Quakertown, Pennsylvania, United States
• LMU Klinikum der Universität — Munich, Bavaria, Germany
• LMU Klinikum der Universität München — München, Bavaria, Germany
• Universitätsklinikum Essen — Essen, North Rhine-Westphalia, Germany
• Universitatsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany
• Universitatsklinikum Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany
• Universitatsklinikum Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany
• SRH Wald-Klinikum Gera GmbH — Gera, Thuringia, Germany
• LMU Klinikum der Universität München — Munich, Germany
• Istituto nazionale Per la Ricerca sul Cancro — Genova, Italy
• Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale — Naples, Italy
• Radboud University Nijmegen Medical Centre — Nijmegen, Gelderland, Netherlands
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands
• Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam, North Holland, Netherlands
• Slotervaartziekenhuis — Amsterdam, North Holland, Netherlands
• Universitätsspital Zürich — Zürich (de), Switzerland

Full record on ClinicalTrials.gov

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