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    TEST:
    cobas® 4800 BRAF V600 Mutation Test

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    6d
    NCI-2013-02103: Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • IO biomarker
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263) • omipalisib (GSK2126458)
    17d
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3, N=300, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    1m
    Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=22, Terminated, National Cancer Institute (NCI) | Active, not recruiting --> Terminated; Drug supply issues
    Trial termination • Combination therapy • Surgery • Metastases
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • onalespib (AT13387)
    7ms
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Jun 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    11ms
    NCI-2013-02103: Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF mutation • BRAF V600 • PTEN mutation • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
    12ms
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2024 --> Jun 2024 | Trial primary completion date: Oct 2024 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    12ms
    Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1; Trial completion date: Jul 2023 --> Dec 2024 | Trial primary completion date: Jul 2023 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    BRAF V600E • BRAF V600 • BRAF V600K • BRAF V600E + BRAF V600K
    |
    cobas® 4800 BRAF V600 Mutation Test
    |
    Tafinlar (dabrafenib) • lapatinib
    1year
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib) • ABP 206 (nivolumab biosimilar)
    almost2years
    Detection of BRAF mutations in malignant melanoma and colorectal cancer by SensiScreen® FFPE BRAF qPCR assay. (PubMed, PLoS One)
    Furthermore, the SensiScreen® FFPE BRAF qPCR Assay identified the specific change in the amino acid. The SensiScreen® FFPE BRAF qPCR Assay will contribute to a more specific, time and cost saving approach to better identify and characterize mutations in patients affected by cancer, and consequently permits a better BRAF characterization that is fundamental for therapy decision.
    Journal
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600 • BRAF exon 15 mutation
    |
    cobas® 4800 BRAF V600 Mutation Test
    almost2years
    Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
    2years
    DREAMseq: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma (clinicaltrials.gov)
    P3; Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Oct 2022 --> Oct 2023
    Trial completion date • Trial primary completion date
    |
    BRAF mutation • BRAF V600
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Opdivo (nivolumab) • Mekinist (trametinib) • Yervoy (ipilimumab) • Tafinlar (dabrafenib)
    over2years
    Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2022 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    cobas® 4800 BRAF V600 Mutation Test
    |
    Tafinlar (dabrafenib) • lapatinib
    over2years
    Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma (clinicaltrials.gov)
    P1/2; Recruiting --> Active, not recruiting
    Enrollment closed
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • navitoclax (ABT 263)
    over3years
    [VIRTUAL] The use of ctDNA for BRAF mutations testing in routine clinical practice in patients with advanced melanoma (EADO-WCM 2021)
    "ctDNA is a feasible source of genetic material for BRAF mutations assessment in patients with advanced melanoma in clinical practice, especially when a tissue sample is not available or in patients with rapidly progressive disease. The median TAT for ctDNA testing is significantly shorter than for tissue samples, while sensitivity and specificity are>80% highlighting the clinical utility of liquid biopsy. Treatment with BRAF/MEKi based on the results of liquid biopsy gives comparable outcomes to those reported in the literature for the general population."
    Clinical
    |
    BRAF (B-raf proto-oncogene) • KIT (KIT proto-oncogene, receptor tyrosine kinase)
    |
    BRAF mutation • BRAF V600
    |
    cobas® 4800 BRAF V600 Mutation Test • therascreen® BRAF V600E RGQ PCR • AmoyDx® BRAF V600 Mutations Detection Kit
    4years
    [VIRTUAL] A case of metastatic melanoma – BRAF molecular testing as a diagnostic tool (ECP 2020)
    The case was diagnosed as metastatic dedifferentiated melanoma. Conclusion In practice, the result of molecular analysis is used to direct treatment decisions, however in selected cases it can also serve as an important diagnostic tool in particular when immunohistochemical analysis is unhelpful.
    Clinical
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E
    |
    cobas® 4800 BRAF V600 Mutation Test
    4years
    [VIRTUAL] A case of metastatic melanoma – BRAF molecular testing as a diagnostic tool (ECP 2020)
    The case was diagnosed as metastatic dedifferentiated melanoma. Conclusion In practice, the result of molecular analysis is used to direct treatment decisions, however in selected cases it can also serve as an important diagnostic tool in particular when immunohistochemical analysis is unhelpful.
    Clinical
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E
    |
    cobas® 4800 BRAF V600 Mutation Test
    4years
    [VIRTUAL] A case of metastatic melanoma – BRAF molecular testing as a diagnostic tool (ECP 2020)
    The case was diagnosed as metastatic dedifferentiated melanoma. Conclusion In practice, the result of molecular analysis is used to direct treatment decisions, however in selected cases it can also serve as an important diagnostic tool in particular when immunohistochemical analysis is unhelpful.
    Clinical
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E
    |
    cobas® 4800 BRAF V600 Mutation Test
    almost6years
    A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma (clinicaltrials.gov)
    P1, N=15, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600
    |
    cobas® 4800 BRAF V600 Mutation Test
    |
    Zelboraf (vemurafenib)