Clinical Trials /

Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma

NCT02427893

Description:

This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma.

Related Conditions:
  • Melanoma
Recruiting Status:

Withdrawn

Phase:

Phase 3

Trial Eligibility

Document

Trial of Vemurafenib and <span class="go-doc-concept go-doc-intervention">Cobimetinib</span> in Patients With Advanced BRAFV600 <span class="go-doc-concept go-doc-keyword">Mutant</span> <span class="go-doc-concept go-doc-disease">Melanoma</span>

Title

  • Brief Title: Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma
  • Official Title: An Exploratory Study of the Immunological Effects of Vemurafenib and Cobimetinib, Administered Alone and in Combination, in Subjects With Advanced BRAF V600E/K Mutant Melanoma
  • Clinical Trial IDs

    NCT ID: NCT02427893

    ORG ID: J1517

    NCI ID: IRB00051085

    Trial Conditions

    Melanoma

    Trial Interventions

    Drug Synonyms Arms
    Cobimetinib GDC-0973, XL518 Cohort 1, Cohort 2
    Vemurafenib RO5185426, PLX4032, or RG7204 Cohort 1, Cohort 2

    Trial Purpose

    This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib
    (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF
    V600E/K mutant melanoma.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Cohort 1 Active Comparator Ten patients begin Vemurafenib monotherapy, after 10 days, begin combination therapy by adding Cobimetinib. Cobimetinib, Vemurafenib
    Cohort 2 Active Comparator Ten patients begin Cobimetinib monotherapy, after 10 days, begin combination therapy by adding Vemurafenib. Cobimetinib, Vemurafenib

    Eligibility Criteria

    Inclusion Criteria:

    - Signed informed consent

    - Life expectancy 12 weeks

    - Able to swallow pills

    - ECOG performance status 2 or less

    - Adequate bone marrow function

    - Adequate renal function

    - Adequate liver function

    - Negative urine pregnancy test within 7 days prior to commencement of dosing in
    premenopausal women

    - Histological diagnosis of unresectable AJCC stage III or stage IV, BRAFV600E/K mutant
    melanoma

    - Measurable disease

    - Naive to systemic therapy

    Exclusion Criteria:

    - Active systemic infection

    - Active autoimmune disease or history of known or suspected autoimmune disease

    - Active brain metastases or leptomeningeal metastases

    - Treatment with any immunomodulatory medication within 4 weeks of initiation of study
    therapy.

    - Positive test for hepatitis B virus

    - Positive test for hepatitis C virus

    - Positive test for human immunodeficiency virus (HIV)

    - Pregnant, lactating or breast feeding women

    - Localized radiation therapy within the last 14 days

    - Prior systemic therapy for melanoma

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Safety and tolerability of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.

    Secondary Outcome Measures

    Anti-tumor activity of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.

    Trial Keywords

    immunotherapy

    Vemurafenib

    Cobimetinib