A Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in patients with unresectable or metastatic BRAF V600 mutant melanoma - COLUMBUS

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; unresectable or metastatic BRAF V600 mutant melanoma; MedDRA version: 16.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2013-001176-38-FR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-24
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma (AJCC Stage IIIB, IIIC, or IV)
• Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
• Naïve untreated patients for unresectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy or radiotherapy)
• Evidence of at least one measurable lesion as detected by radiological or photographic methods
• ECOG performance status of 0 or 1
• Adequate bone marrow, organ function, cardiac and laboratory parameters
• Normal functioning of daily living activities

Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

• Any active/non-stable brain lesion
• Non-cutaneous melanoma
• History of leptomeningeal metastases
• History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease.
• Patients with washout period < 12 weeks from the last dose of ipilimumab or other immunotherapy.
• Any previous anti-cancer treatment, extensive radiotherapy or investigational agent for locally advanced unresectable or metastatic melanoma; prior systematic treatment in adjuvant setting (including ipilimumab) is allowed
• History of Gilbert's syndrome
• Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
• Impaired cardiovascular function or clinically significant cardiovascular diseases
• Uncontrolled arterial hypertension despite medical treatment
• HIV positive or active Hepatitis B, and/or active Hepatitis C
• Impairment of gastrointestinal function or gastrointestinal disease
• Patients with neuromuscular disorders that are associated with elevated CK.
• Pregnant or nursing (lactating) women
• Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified