Malignant solid neoplasm, BRAF-mutated

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Last updated on 2024-07-23:2 regimens on this page
2 variants on this page
Note: most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.
=All lines of therapy=
==Dabrafenib & Trametinib==
===Regimen===
Study 	Dates of enrollment	Evidence
Salama et al. 2020 (EAY131-H)	2015-08 to 2018-02 	Non-randomized
====Biomarker eligibility criteria====
*Gene: BRAF V600E
*Alteration: substitution
*Acceptable methods of measurement: archival or fresh tumor tissue
====Prior treatment criteria====
*No prior treatment with BRAF and/or MEK inhibitor(s)
====Targeted therapy====
*Dabrafenib (Tafinlar) 150 mg PO twice per day on days 1 to 28
*Trametinib (Mekinist) 2 mg PO once per day on days 1 to 28
28-day cycles
===References===
#EAY131-H: Salama AKS, Li S, Macrae ER, Park JI, Mitchell EP, Zwiebel JA, Chen HX, Gray RJ, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Armstrong DK, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. J Clin Oncol. 2020 Nov 20;38(33):3895-3904. Epub 2020 Aug 6. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02465060
==Vemurafenib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Hyman et al. 2015 (VE-BASKET) 	2012-2014 	Phase 2
Hainsworth et al. 2018 (MyPathway)	2014-2016 	Phase 2a
====Biomarker eligibility criteria====
*VE-BASKET:
**Gene: BRAF V600 
**Alteration: substitution
**Acceptable methods of measurement: mutational analysis assays
*MyPathway:
**Gene: BRAF V600E 
**Alteration: substitution
**Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
**Biomarker exclusions: no coexisting KRAS mutations, or other BRAF mutations
====Prior treatment criteria====
*VE-BASKET: no prior treatment with BRAF and/or MEK inhibitor(s)
====Targeted therapy====
*Vemurafenib (Zelboraf) 960 mg PO twice per day
Continued indefinitely
===References===
#VE-BASKET: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015 Aug 20;373(8):726-736. link to original article dosing details in abstract have been reviewed by our editors link to PMC article EuroPMC NCT01524978
#MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02091141
Category:Malignant solid neoplasm, BRAF-mutated regimens
Category:Biomarker-specific pages
Category:Malignant solid neoplasm