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    Association details:
    Biomarker:BRAF mutation
    Cancer:Melanoma
    Drug:Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor) +
    Cotellic (cobimetinib) (MEK1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

    Excerpt:
    ...- Histologically confirmed metastatic melanoma (Stage IV), carrying BRAF V600-mutation...
    Trial ID:
    CoBRIM-B
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

    Excerpt:
    ...Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue BRAF V600 mutation test; 6....
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

    Excerpt:
    ...- Documentation of BRAF V600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test...
    Trial ID:
    NCT02768207
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma

    Excerpt:
    ...- Patients who have had prior therapy with a MEK inhibitor or an inhibitor of mutant BRAF are ineligible....
    Trial ID:
    NCT01813214
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

    Excerpt:
    ...Confirmed diagnosis of a malignancy harbouring any actionable BRAF V600 mutation using an analytically validated sequencing technique (result does...
    Trial ID:
    DETERMINE
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

    Excerpt:
    ...- Histologically confirmed metastatic melanoma (stage IV, per AJCC staging), carrying BRAF V600-mutation...
    Trial ID:
    RadioCoBRIM
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases

    Excerpt:
    ...BRAF V600 mutation positive....
    Trial ID:
    NCT02036086
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

    Excerpt:
    ...- Documentation of BRAF V600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) using the cobas 4800 BRAF V600 mutation test...
    Trial ID:
    coBRIM
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation

    Excerpt:
    ...Untreated and pretreated (no more than 1 treatment) patients with metastatic melanoma at stage unreseactable IIIb-IV, histologically confirmed, that show V600 type BRAF mutations....
    Trial ID:
    VEMUPLINT
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Clin Nucl Med
    Title:

    The Predictive Value of FDG PET/CT for Determining Progression-Free Survival in Advanced Stage III-IV BRAF-Mutated Melanoma Patients Treated With Targeted Therapy-What Can Be Learned From Progression?

    Published date:
    12/19/2023
    Excerpt:
    This prospective multicenter single-arm study included 70 patients with unresectable stage III/IV BRAF-mutated melanoma who underwent contrast-enhanced CT and 18F-FDG PET/CT at baseline and 2 and 7 weeks during treatment with vemurafenib plus cobimetinib...PERCIST median PFS was 15.7 months for patients with complete metabolic response (CMR) versus 8.3 months for non-CMR (P = 0.035).
    DOI:
    10.1097/RLU.0000000000004988
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Melanoma Res
    Title:

    Survival in adult patients with BRAFV600 mutation-positive advanced melanoma: a noninterventional ambispective study of patients with cobimetinib combined with vemurafenib during the French early access program: MELANIS study

    Published date:
    05/27/2022
    Excerpt:
    This noninterventional, ambispective, multicentre French study, conducted in patients previously registered in TAU, aimed to estimate overall survival (OS) and progression-free survival (PFS) and to describe the tolerability of the therapeutic combination....Median PFS was 7.3 months (95% CI, 5.2-8.4)....This study provides real-world outcomes in France for the vemurafenib-cobimetinib combination available in patients with BRAF-mutant-advanced melanoma.
    DOI:
    10.1097/CMR.0000000000000833