Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BKM120 Combined with Vemurafenib · 1 trial · 1 indication
RP2D determined by maximum tolerated dose (MTD), post-dose-limiting toxicity (DLT) period toxicity, and pharmacokinetic data
6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests
| Arm | Type | Description |
|---|---|---|
| No Previous Treatment | OTHER | 150 mg oral dabrafenib twice a day until disease progression, death, or unacceptable adverse events. |
| Name | Type | Description |
|---|---|---|
| BKM120 Combined with Vemurafenib (PLX4032) | DRUG | Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D) Dose Level -1: BKM120 60 mg daily, Vemurafenib 480 mg bid Dose Level 1: BKM120 60 mg daily, Vemurafenib 720 mg bid Dose Level 2: BKM120 80 mg daiy, Vemurafenib 720 mg bid Dose Level 3: BKM120 100 mg daiy, Vemurafenib 720 mg bid Dose Level 4: BKM120 100 mg daiy, Vemurafenib 960 mg bid Phase II is a single-stage, single arm prospective trial: patients will receive BKM120 and vemurafenib at the RP2D |
Inclusion Criteria 1. Histologically or cytologically confirmed diagnosis of unresectable stage III and stage IV melanoma 2. BRAFV600E or BRAFV600K mutation-positive 3. Age \>= 18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 5. Patients must have at least one site of ...
BKM120 Combined with Vemurafenib is an investigational combination regimen being studied in BRAF mutant metastatic melanoma. It pairs the small molecule BKM120 with vemurafenib, also known as PLX4032, in patients whose tumors carry BRAF V600E or V600K mutations. The combination was evaluated in a single Phase 1 trial conducted in the United States.
BKM120 Combined with Vemurafenib is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical program evaluating this small molecule combination in BRAF mutant metastatic melanoma.
BKM120 Combined with Vemurafenib is in Phase 1 clinical development. The program has completed one Phase 1 trial, and no active trials are currently listed. The regimen remains investigational and has not been approved by the FDA for any indication.
BKM120 Combined with Vemurafenib was studied in the Phase 1 trial NCT01512251, titled BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma. The completed trial enrolled 8 participants aged 18 years and older in the United States. It was an uncontrolled, non-randomized study without blinding.
BKM120 Combined with Vemurafenib is also known as BKM120 Combined with Vemurafenib (PLX4032). PLX4032 is the alternate designation for vemurafenib, the BRAF inhibitor paired with BKM120 in this combination regimen. Both names refer to the same investigational combination studied in BRAF mutant metastatic melanoma.