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    Association details:
    Biomarker:TMB-H
    Cancer:Vulvar Cancer
    Drug:Keytruda (pembrolizumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    04/26/2021
    Excerpt:
    Vulvar cancer (Squamous cell carcinoma): Advanced or recurrent/metastatic disease…Biomarker-directed systemic therapy for second-line treatment…Pembrolizumab (second-line therapy for TMB-H, PD-L1-positive, or MSI-high [MSI-H]/MMR deficient [dMMR] tumors)
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for Solid Tumor)
    New
    Excerpt:
    KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated:...for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

    Excerpt:
    ...- Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (≥10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors....
    Trial ID:
    KEYNOTE-158