Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01245062 | GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma | PHASE3 | COMPLETED | 322 | — | — | Nov 22, 2010 | Dec 16, 2016 | Apr 5, 2018 | 112 | United States, Argentina +17 |
Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.
| Arm | Type | Description |
|---|---|---|
| GSK1120212 | EXPERIMENTAL | MEK inhibitor |
| Chemotherapy | ACTIVE_COMPARATOR | Investigator Choice of DTIC or paclitaxel |
| Crossover | EXPERIMENTAL | MEK inhibitor after documented progression on Chemotherapy Arm |
| Name | Type | Description |
|---|---|---|
| GSK1120212 | DRUG | MEK inhibitor |
| Chemotherapy | DRUG | Investigator Choice of DTIC or paclitaxel |
Inclusion Criteria: * ≥18 years of age * Stage III unresectable (Stage IIIc) or metastatic (Stage IV) cutaneous melanoma which is also determined to be BRAF V600E/K mutation-positive by the central laboratory * Received no prior treatment or up to one prior regimen of chemotherapy for advanced or m...