Clinical trial · Interventional
LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
Phase II, Multi-center, Open-label Study of Single-agent LGX818 Followed by a Rational Combination With Agents After Progression on LGX818, in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma
NCT01820364CI-TRIAL-00025403LOGICterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was withdrawn due to scientific and business considerations.
Summary
Brief summary (as posted)
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LGX818 | Drug | Encorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LGX818 single agent
- description
- Patients had to have written documentation of a BRAFV600 mutation, which was to have been obtained locally on a fresh tumor biopsy (preferred) or on the most recent archival tumor sample available.
- interventionNames
- Drug: LGX818
Primary outcomes (1)
- measure
- Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)
- timeFrame
- Baseline through study completion (approximately 2 years)
- description
- Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment. The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment. Per RECIST guidelines: * Complete Response (CR) is the Disappearance of all target lesions. * Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions. * Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions. * Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced or metastatic melanoma * confirmed BRAF V600 mutation * patients naïve to a selective BRAF inhibitor * fresh tumor biopsy at baseline, and patient agrees for a mandatory biopsy at the time of relapse * life expectancy ≥ 3 months * World Health Organization (WHO) Performance Status ≤ 2. Exclusion Criteria: * Previous treatment with RAF-inhibitor * Symptomatic or untreated leptomeningeal disease * Symptomatic brain metastases. * Known acute or chronic pancreatitis * Clinically significant cardiac disease * AST/SGOT and ALT/SGPT \> 2.5 x ULN, or \> 5 x ULN if liver metastases are present * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral interventional drug * Previous or concurrent malignancy. * Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation Specific exclusion criteria for each treatment arm: LGX818/MEK162: History or current evidence of retinal disease History of Gilbert's syndrome. LGX818/BKM120: Patients with diabetes mellitus requiring insulin treatment Patient has mood disorders LGX818/BGJ398: History and/or current evidence of ectopic mineralization/ calcification Current evidence of corneal disorder/ keratopathy Patients with current evidence of endocrine alteration of calcium/phosphate homeostasis. History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry. Ionized (i) calcium (Ca) \> ULN Serum inorganic phosphorus (Pi) \> ULN LGX818/LEE011 History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.