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Association details:
| Biomarker: | BRAF V600E |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | Mektovi (binimetinib) (MEK inhibitor) + Braftovi (encorafenib) (BRAF inhibitor, cRAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Excerpt:
BRAFTOVI is a kinase inhibitor indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test.
Source:
Title:
Encorafenib used with binimetinib versus placebo in BRAF mutant stage IIB/C melanoma after surgery to evaluate the efficacy and safety in preventing melanoma recurrence
Excerpt:
...Molecular Pre-screening 1.Before any related study activity, written informed consent must be given according to ICH/GCP, and national/local regulations; 2.Male or female ≥ 18 years of age; 3.Surgically resected, with tumor free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanoma per AJCC 8th edition; 4.Sentinel node (SN) staged node negative (pN0); 5.Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma; 6.Available tumor sample for central determination of the BRAFV600E/K mutation. ...
Trial ID:
Source:
Title:
Phase 2 Study of Encorafenib and Binimetinib Plus Pembrolizumab inParticipants With BRAF V600E/K Mutation-Positive Melanoma Who Progressed Duringor After Prior Treatment with Anti−PD-1 Therapy
Excerpt:
...Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:- Male or female participants ≥18 years of age at the time of informed consent.- Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic(Stage IV) cutaneous melanoma, according to the AJCC 8th edition.- Documented evidence of a BRAF V600E or V600K mutation.- Submission of adequate tumor tissue for central laboratory testing of BRAF V600E/K mutation and biomarkers is required for all participants during the screening period and prior to randomization.- Must have received only 1 prior line of systemic therapy for melanoma (either adjuvant therapy or first-line anti-PD-1 monotherapy (ie, nivolumab orpembrolizumab).- Must have anti-PD-1 resistant disease (primary or secondary) with confirmed diseaseprogression per RECIST v1.1 either during or after receipt of an approved anti-PD-1monotherapy (ie, nivolumab or pembrolizumab) for melanoma, defined according tothe SITC Immunotherapy Resistance Taskforce (Kluger et al, 2020).- Have at least 1 measurable lesion per RECIST v1.1.- ECOG PS of 0-1, and adequate organ and cardiac function, including LVEF ≥50%by cardiac imaging.`...
Trial ID:
More C2 evidence
Source:
Title:
A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
Excerpt:
...- Documented evidence of a BRAF V600E or V600K mutation....
Trial ID:
Source:
Title:
A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Excerpt:
...- Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked [European conformity] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory....
Trial ID:
Source:
Title:
A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings
Excerpt:
...- Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results....
Trial ID:
Source:
Title:
Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation
Excerpt:
......
Trial ID:
Source:
Title:
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Excerpt:
...- Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization...
Trial ID:
Source:
Title:
An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer
Excerpt:
...- Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay or the presence of other BRAFV600 mutations other than V600E (i.e. K or D) will be considered...
Trial ID:
Source:
Title:
A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors
Excerpt:
...- Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation...
Trial ID:
Source:
Title:
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
Excerpt:
...- Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening...
Trial ID:
Source:
Title:
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Excerpt:
...- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory...
Trial ID:
Source:
Title:
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Excerpt:
...- Available tumour sample for central determination of the BRAF V600E/K mutation....
Trial ID:
Source:
Title:
Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
Excerpt:
...- Presence of a BRAF V600E or V600K mutation, or both, in their tumour tissue....
Trial ID:
Source:
Title:
Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
Excerpt:
...- Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to enrollment, as determined using a local test;...
Trial ID:
Source:
Title:
Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Excerpt:
...- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory -...
Trial ID:
Source:
Title:
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Excerpt:
...Presence of BRAF V600E or V600K mutation in tumour tissue prior to enrolment, as previously determined using a local test at any time prior to Screening...
Trial ID:
Source:
Title:
A study comparing combination of Encorafenib + Binimetinib in Patients with BRAF V600E-mutant Non-small Cell Lung Cancer. Estudio para evaluar la combinación de Encorafenib + Binimetinib en pacientes con cáncer de pulmón no microcítico con mutación BRAFV600E
Excerpt:
...Presence of a BRAFV600E mutation in lung cancer tissue as determined by a local laboratory assay. ...
Trial ID:
Source:
Title:
International multicenter study to test the use of 3 combined targeted therapy drugs for Colorectal cancer (encorafenib, binimetinib and cetuximab) in subjects with mutant Metastatic Colorectal Cancer
Excerpt:
...Presence of BRAFV600E mutation in tumor tissue previously determined by a local assay at any time prior to screening.Notes:a. ...
Trial ID:
Source:
Title:
A study comparing combination of Encorafenib + Binimetinib as a standard-dose and a High-dose Regimen in patients with BRAFV600-Mutant Melanoma Brain Metastasis
Excerpt:
...Presence of BRAFV600 mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.5. ...
Trial ID:
Source:
Title:
A study of binimetinib and encorafenib in patients aged 12 to 17 with a specific type of melanoma (BRAF V600-mutant melanoma) that cannot be completely removed by surgery or that has spread to other areas in the body.
Excerpt:
...- Male or female 12 to < 18 years of age at the time of consent/assent.- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma American Joint Committee on Cancer Stage IIIB, IIIC, or IV.- Presence of BRAF V600E or V600K mutation in tumor tissue as determined by a local or central laboratory.- Evidence of at least one evaluable lesion (measurable or non-measurable) as detected by radiological or photographic methods based on RECIST v1.1.- Adequate cardiac function:a. ...
Trial ID:
Source:
Title:
Encorafenib used with binimetinib versus placebo in BRAF mutant stage II melanoma after surgery to evaluate the efficacy and safety in preventingmelanoma recurrence Encorafenib utilizzato con binimetinib rispetto al placebo nel melanoma in stadio II con mutazione BRAF dopo l'intervento chirurgico per valutare l'efficacia e la sicurezza nella prevenzione recidiva del melanoma
Excerpt:
...Melanoma determined locally to be V600E/K mutation-positive. ...
Trial ID:
Less C2 evidence
Source:
Title:
A phase 1b/2 study of the BRAF inhibitor encorafenib plus the MEK inhibitor binimetinib in patients with BRAF V600E/K-mutant solid tumors
Published date:
07/15/2020
Excerpt:
The combination of encorafenib (450 mg) plus binimetinib (45 mg) showed acceptable tolerability and encouraging activity in patients with BRAF V600-mutant tumors.
DOI:
10.1158/1078-0432.CCR-19-3550
Trial ID:
