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

NCT01667419

Description:

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.

Related Conditions:
  • Melanoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous <span class="go-doc-concept go-doc-biomarker">BRAF</span> <span class="go-doc-concept go-doc-keyword">Mutant</span> <span class="go-doc-concept go-doc-disease">Melanoma</span>

Title

  • Brief Title: BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma
  • Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF Mutant Melanoma at High Risk for Recurrence
  • Clinical Trial IDs

    NCT ID: NCT01667419

    ORG ID: GO27826

    NCI ID: 2011-004011-24

    Trial Conditions

    Malignant Melanoma

    Trial Interventions

    Drug Synonyms Arms
    Placebo Placebo Arm
    vemurafenib Vemurafenib Arm

    Trial Purpose

    This multi-center, randomized, double-blind, placebo-controlled study will evaluate the
    efficacy and safety of vemurafenib in patients with completely resected, cutaneous
    BRAF-mutation positive melanoma at high risk for recurrence. Patients will be randomized to
    receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated
    time on study treatment is 52 weeks.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Placebo Arm Placebo Comparator Placebo
    Vemurafenib Arm Experimental vemurafenib

    Eligibility Criteria

    Inclusion Criteria:

    - All patients should have histologically confirmed melanoma of cutaneous origin

    - Patients must have been surgically rendered free of disease within 90 days of
    randomization

    - Eastern Cooperative Oncology Group performance status of 0 or 1

    - Life expectancy of at least 5 years

    - Patients must have fully recovered from the effects of any major surgery or
    significant traumatic injury prior to the first dose of study treatment

    - Adequate hematologic, hepatic and renal function

    Exclusion Criteria:

    - History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted
    therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention
    of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b

    - History of limb perfusion therapy

    - History of radiotherapy for the treatment of melanoma

    - Invasive malignancy other than melanoma at the time of enrollment or within 5 years
    prior to first dose of study treatment

    - Family history of colon cancer syndromes

    - History of clinically significant cardiac or pulmonary dysfunction

    - Major surgical procedure within 4 weeks prior to first dose of study treatment

    - Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Disease-free survival

    Secondary Outcome Measures

    Overall survival

    Distant metastases-free survival

    Safety: incidence of adverse events

    Quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

    Pharmacokinetics: plasma concentration of vemurafenib

    Trial Keywords