Clinical trial · Interventional
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
A Phase Ib/II, Multicenter, Study of LEE011 in Combination With LGX818 in Adult Patients With BRAF Mutant Melanoma.
NCT01777776CI-TRIAL-00023842terminatedPhase 1 / Phase 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Why stopped (as posted): Study was withdrawn due to scientific and business considerations.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)
To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
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 |
|---|---|---|---|
| Locally Advanced Metastatic BRAF Mutant Melanoma | Melanoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LEE011 | Drug | Ribociclib | ALIAS |
| LGX818 | Drug | Encorafenib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase Ib
- description
- Phase Ib will randomize 18 patients with BRAF mutant melanoma, who are naïve or who have progressed on prior therapy to evaluate the safety and tolerability of the combination of LEE011 and LGX818.
- interventionNames
- Drug: LEE011
- Drug: LGX818
- type
- EXPERIMENTAL
- label
- Phase II arm 1a
- description
- Phase II arm 1a will randomize 60 patients that are naïve to prior BRAF inhibitor therapy to LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.
- interventionNames
- Drug: LEE011
- Drug: LGX818
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Diagnosis of locally advanced or metastatic melanoma along with written documentation of BRAF V600 mutation. * ECOG performance status of 0 - 2. * Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable disease as determined by RECIST v1.1. * Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of measurable disease as determined by RECIST v1.1. * Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh tumor sample is acceptable. * For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh tumor biopsy unless one was collected prior to study entry but at the time of disease relapse from the most recent BRAFi treatment. Exclusion Criteria: * Symptomatic brain metastases. * Symptomatic or untreated leptomeningeal disease. * Patients with inadequate laboratory values during screening. * In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD 0332991) * Impaired cardiac function or clinically significant cardiac diseases. * Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 or LGX818. * Patients with concurrent severe and/or uncontrolled concurrent medical conditions. * Previous or concurrent malignancy. * Major surgery \< 2 weeks before starting study treatment * Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.