British Journal of Cancer

Table 1 Clinical trials for BRAF-mutant only patients

From: Beyond BRAF: where next for melanoma therapy?

NCT ID	Genotype	Drug	Target	Phase	Status	Results	Reference
NCT01006980	BRAF	Dacarbazine Vemurafenib	Chemotherapy BRAF	3	Active	Vemurafenib group: OS at 6 months 84% (95% CI), 48% response rate Dacarbazine group: OS at 6 months 64% (95% CI, 56–73), 5% response rate	Chapman et al (2011)
NCT01227889	BRAF	Dacarbazine Dabrafenib	Chemotherapy BRAF	3	Active	Dabrafenib: mPFS 5.1 months Dacarbazine: mPFS 2.7 months With hazard ratio (HR) of 0.30 (95% CI 0.18–0.51; P<0.0001)	Hauschild et al (2012)
NCT01245062	BRAF	Dacarbazine or Paclitaxel Trametinib	Chemotherapy MEK	3	Active	Trametinib: mPFS 4.8 months, OS at 6 months 81% Chemotherapy: mPFS 1.5 months, OS at 6 months 67% Hazard ratio for disease progression or death in the trametinib group, 0.45; 95% CI, 0.33 to 0.63; P<0.001. Hazard ratio for death, 0.54; 95% CI, 0.32–0.92; P=0.01	Flaherty et al (2012b)
NCT01072175	BRAF	Dabrafenib Trametinib	BRAF MEK	2	Active	Combination group: mPFS 9.4 months, 76% complete or partial response Dabrafenib group: mPFS 5.8 months, 54% complete or partial response Hazard ratio for progression or death, 0.39; 95% confidence interval, 0.25–0.62; P<0.001	Flaherty et al (2012a)
NCT00304525	BRAF	RAF265	Pan-RAF	2	Completed		^a
NCT01657591	BRAF	Vemurafenib XL888	BRAF HSP90	1	Recruiting		^a
NCT02068079	BRAF	Vemurafenib Trientine	BRAF Copper chelator	1	Recruiting		^a
NCT01902173	BRAF	Dabrafenib GSK2141795	BRAF AKT	1/2	Recruiting		^a
NCT01820364	BRAF	LGX818 and: MEK162 LEE011 BGJ398 BKM120 INC280	BRAF MEK CDK4/6 FGFR PI3K c-MET	2	Recruiting		^a
NCT00936221	BRAF	Dacarbazine Selumetinib	Chemotherapy MEK	2	Active	OS did not differ significantly between groups, PFS improved with selumetinib. Selubetinib+dacarbazine group: mOS 13.9 months (80% CI 10.2–15.6), mPFS 5.6 months Dacarbazine group: mOS 10.5 months (80% CI 9.6–14.7), mPFS 3.0 months	Robert et al (2013)
NCT01495988	BRAF	Vemurafenib Bevacizumab	BRAF angiogenesis	2	Recruiting		^a
NCT01826448	BRAF	Vemurafenib PLX3397	BRAF CSF1R, KIT, FLT3	1	Recruiting		^a
NCT01841463	BRAF	Vemurafenib P1446A	BRAF CDK4	1	Recruiting		^a
NCT01616199	BRAF	Vemurafenib PX-866	BRAF PI3K	1/2	Recruiting		^a
NCT02097225	BRAF	AT13387 Dabrafenib Trametinib	HSP-90 BRAF MEK	1	Recruiting		^a
NCT01519427	BRAF, failed BRAFi	Selumetinib MK2206	MEK AKT	2	Terminated	Study terminated due to slow accrual, total of 2 patients. OS 153 days, PFS 105 days, SD in 1 patient and PD in 1 patient	^a

Abbreviations: CI=confidence interval; CR=complete response; mOS=median overall survival; mPFS=median progression-free survival; OS=overall survival; ORR=objective response rate; PD=progressive disease; PFS=progression-free survival; PR=partial response; SD=stable disease.
^aClinicaltrials.org.

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