Clinical trial · Interventional
A Phase II Study of Single Agent MEK162 in Patients With Advanced Melanoma
A Phase II, Open-label Study to Assess the Safety and Efficacy of Oral MEK162 in Adults With Locally Advanced and Unresectable or Metastatic Malignant Cutaneous Melanoma, Harboring BRAFV600 or NRAS Mutations
NCT01320085CI-TRIAL-00073278completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRAF or NRAS Mutant Metastatic Melanoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEK162 | Drug | Binimetinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BRAFV600 mutant, 45mg bid MEK162
- description
- BRAFV600 mutant, 45mg bid MEK162
- interventionNames
- Drug: MEK162
- type
- EXPERIMENTAL
- label
- NRAS mutant, 45mg bid MEK162
- description
- NRAS mutant, 45mg bid MEK162
- interventionNames
- Drug: MEK162
- type
- EXPERIMENTAL
- label
- BRAFV600 mutant, 60mg bid MEK162
- description
- BRAFV600 mutant, 60mg bid MEK162
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAscierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. doi: 10.1016/S1470-2045(13)70024-X. Epub 2013 Feb 13. PMID 23414587