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    TEST:
    cobas® 4800 BRAF V600 Mutation Test

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    3ms
    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=267, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> Sep 2026
    Trial completion date
    |
    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)
    3ms
    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 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    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) • ABP 206 (nivolumab biosimilar)
    7ms
    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: Dec 2024 --> Jun 2026 | Trial primary completion date: Dec 2024 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    cobas® 4800 BRAF V600 Mutation Test
    |
    Tafinlar (dabrafenib) • lapatinib
    8ms
    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: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
    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) • ABP 206 (nivolumab biosimilar)
    1year
    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
    |
    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) • omipalisib (GSK2126458)
    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: 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)
    1year
    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; Active, not recruiting --> Terminated; Drug supply issues
    Combination therapy • Trial termination • Surgery • Metastases
    |
    BRAF V600E • BRAF V600 • BRAF V600K
    |
    THXID® BRAF Kit • cobas® 4800 BRAF V600 Mutation Test
    |
    Mekinist (trametinib) • Tafinlar (dabrafenib) • onalespib (AT13387)
    over1year
    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)
    almost2years
    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)
    almost2years
    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)
    almost2years
    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
    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 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)