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    Association details:
    Biomarker:BRAF V600
    Cancer:Melanoma
    Drug:Zelboraf (vemurafenib) (BRAF inhibitor, BRAF V600E inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    02/17/2012
    Excerpt:
    Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pilot Study of Trientine With Vemurafenib for the Treatment BRAF Mutated Metastatic Melanoma

    Excerpt:
    ...Histologic diagnosis of unresectable stage IIIC or stage IV melanoma that is BRAF V600 mutation positive 4....
    Trial ID:
    NCT02068079
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)

    Excerpt:
    ...- Diagnosis of BRAF-V600 mutation-positive unresectable or metastatic melanoma confirmed by a validated test and being treated with vemurafenib...
    Trial ID:
    NCT01990248
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases

    Excerpt:
    ...- Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation (cobas 4800 BRAF V600 Mutation Test)...
    Trial ID:
    NCT01253564
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

    Excerpt:
    ...- Unresectable Stage IIIc or IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type which harbors a V600 activating mutation of BRAF, as determined by Cobas 4800 BRAFV600 Mutation Test or a DNA sequencing method...
    Trial ID:
    NCT01844674
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases

    Excerpt:
    ...- Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations....
    Trial ID:
    NCT01781026
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

    Excerpt:
    ...- Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have...
    Trial ID:
    NCT01851824
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

    Excerpt:
    ...- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have...
    Trial ID:
    NCT01765556
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

    Excerpt:
    ...BRAFV600 mutation positive (cobas 4800 BRAFV600 mutation test) 4....
    Trial ID:
    NCT02145910
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    BRIM-P: A Study of Vemurafenib in Pediatric Patients With Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

    Excerpt:
    ...- Positive proto-oncogene B-Raf (BRAF) mutation result (Cobas 4800 BRAF V600 Mutation Test)...
    Trial ID:
    BRIM-P
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

    Excerpt:
    ...- positive for BRAF V600E mutation...
    Trial ID:
    BRIM 3
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma

    Excerpt:
    ...- positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)...
    Trial ID:
    NCT01107418
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma

    Excerpt:
    ...- Confirmed and measurable metastatic melanoma with the BRAFV600 mutation....
    Trial ID:
    PROCLIVITY 01
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Safety Study of PLX4032 in Patients With Solid Tumors

    Excerpt:
    ...- Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF mutation confirmed prior to the administration of PLX4032...
    Trial ID:
    NCT00405587
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma

    Excerpt:
    ...- BRAF V600E positive mutation (by Roche CoDx BRAF mutation assay)...
    Trial ID:
    NCT00949702
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study Of Zelboraf (Vemurafenib) in Patients With Locally-Advanced, Unresectable, Stage IIIc Or Metastatic Melanoma and Activating Exon 15 BRAF Mutations Other Than V600E

    Excerpt:
    ...- Histologically-confirmed metastatic melanoma (unresectable Stage IIIc or IV) with an activating BRAF mutation other than V600E, as detected by DNA sequencing of exon 15 performed at a centralized laboratory...
    Trial ID:
    NCT01586195
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma

    Excerpt:
    ...- Melanoma must be documented to contain a BRAF V600 mutation by a CLIA approved assay...
    Trial ID:
    NCT01611675
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma

    Excerpt:
    ...- Positive BRAF V600E mutation result (by Roche CoDx test)...
    Trial ID:
    NCT01164891
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients

    Excerpt:
    ...Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer); 3....
    Trial ID:
    NCT01638676
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

    Excerpt:
    ...- Patients must have histologically confirmed diagnosis of Stege IV metastic melanoma positive for BRAF V600E mutation by either the COBAS test or other CLIA approved assay....
    Trial ID:
    NCT01897116
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State

    Excerpt:
    ...- Participants with age greater than or equal to (>=) 18 years with either unresectable Stage IIIC or Stage IV metastatic melanoma positive for the BRAF V600 mutation, or other malignant tumor types that harbor a V600-activating mutation of BRAF...
    Trial ID:
    NCT02608034
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    The Safety and Efficacy Study of Vemurafenib (CT) Compared With Vemurafenib (Zelbolaf®) in Advanced Patients Harboring the V600 BRAF Mutation

    Excerpt:
    ...- Signed written informed consent - Recheck the results of histological studies and paraffin blocks - Histologically confirmed cancer that is either Stage IIIc (unresectable) or ---Stage IV (metastatic), and determined to be BRAF V600E or V600K mutation-positive by the local laboratory. ...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pharmacokinetics (PK) Study to Investigate the Effect of Rifampin on PK of Vemurafenib (Zelboraf)

    Excerpt:
    ...- Participants with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAF V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a Deoxyribonucleic acid (DNA) sequencing method, and who have...
    Trial ID:
    NCT01765543
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

    Excerpt:
    ...- Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have...
    Trial ID:
    NCT01849666
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    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

    Excerpt:
    ...- Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test...
    Trial ID:
    NCT01264380
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of RO5185426 in Patients With Metastatic Melanoma

    Excerpt:
    ...- Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test...
    Trial ID:
    NCT01248936
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

    Excerpt:
    ...- A confirmed EBRAFV600E or KBRAFV600K mutation....
    Trial ID:
    NCT01474551
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Pharmacokinetics Study to Investigate the Effect of Vemurafenib on Digoxin in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma

    Excerpt:
    ...- Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have...
    Trial ID:
    NCT01765569
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    An Open-Label Study of Zelboraf (Vemurafenib) in Patients With Braf V600 Mutation Positive Metastatic Melanoma

    Excerpt:
    ...- Patients with histologically confirmed metastatic melanoma (surgically incurable and unresectable stage IIIC or stage IV; AJCC) with documented BRAF V600 mutation determined by the cobas® BRAF V600 Mutation Test prior to administration of vemurafenib....
    Trial ID:
    NCT01898585
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

    Excerpt:
    ...- Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected...
    Trial ID:
    BRIM8
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Bioavailability Study of Vemurafenib in Participants With BRAF^V600 Mutation-Positive Malignancies

    Excerpt:
    ...- Participants with either unresectable or metastatic melanoma positive for the BRAF^V600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, and for whom vemurafenib is an accepted standard of care or where there is...
    Trial ID:
    NCT02441465
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    A multicenter phase II study evaluating the effect and tolerability of vemurafenib in combination with Pegylated Interferon and Interleukin-2 in patients with metastatic melanoma positive for the BRAF-mutation En multicenter fase II undersøgelse af vemurafenib i kombination med Pegyleret Interferon og Interleukin-2 til patienter med BRAF-muteret metastatisk malignt melanom

    Excerpt:
    ...•Histologically verified unresectable stage III or stage IV melanoma with documented BRAF V600 mutation determined by the cobas® 4800 BRAF mutation test •Age between 18 and 70 •ECOG performance status (PS) 0-2 •Patients must have measurable target lesions disease as defined by RECIST v1.1 •Prior medical treatment for metastatic melanoma is allowed, except previous treatment with BRAF-inhibitor and IL-2 based immunotherapy •Adequate cardiac function (less or equal to NYHA II). ...
    Trial ID:
    2013-000773-71
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma

    Excerpt:
    ...- Positive BRAF V600 mutation result determined by a designated laboratory using the Cobas 4800 BRAF V600 Mutation Test...
    Trial ID:
    NCT01910181
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    J Adv Pract Oncol
    Title:

    Vemurafenib: First-in-Class BRAF-Mutated Inhibitor for the Treatment of Unresectable or Metastatic Melanoma

    Excerpt:
    Mutated BRAF is a new target for the treatment of advanced melanoma and provides an important opportunity for new therapies. Vemurafenib is indicated as an option for first-line therapy in patients with unresectable or metastatic melanoma with BRAF V600E mutation. Vemurafenib has shown increases in overall and progression-free survival compared with dacarbazine