Phase 3 study for advanced wild type melanoma

A PHASE III, OPEN-LABEL, MULTICENTER, TWO-ARM, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED BRAFV600 WILD-TYPE MELANOMA

September 18, 2018

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Tan, Ciara Natasha

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: 17.163.12

    Protocol Abbrev: CO39722

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Treatment: COBIMETINIB, ATEZOLIZUMAB, PEMBROLIZUMAB

    Therapies Involved: Oncology: Neo-adjuvant

    ClinicalTrials.gov ID: NCT03273153

  • Objective

    This study will evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus
    atezolizumab compared with pembrolizumab in patients with treatment-naive advanced
    BRAFV600 wild-type melanoma.

  • Key Eligibility

    Patients must meet the following general inclusion criteria for study entry:
    •   Signed Informed Consent Form
    •   Age ≥ 18 years at time of signing Informed Consent Form
    •   Ability to comply with the study protocol, in the investigator’s judgment
    •   Histologically or cytologically confirmed BRAFV600 wild-type melanoma
    •   ECOG Performance Status of 0 or 1
    •   Life expectancy ≥ 3 months
    •   Adequate hematologic and end-organ function, defined using the following laboratory results obtained within 14 days prior to first dose of study drug treatment:
    – ANC ≥ 1.5 × 109/L (1500/μL)
    – Lymphocyte count ≥ 0.5 × 109/L (500/μL)
    – Platelet count ≥ 100 × 109/L (100,000/μL) without transfusion
    – Hemoglobin ≥ 90 g/L (9 g/dL)
    Patients may be transfused to meet this criterion.
    – Platelet count ≥ 100 × 109/L (100,000/μL) without transfusion
    – Creatinine clearance ≥ 40 mL/min
    – Amylase and lipase ≤ 1.5 × ULN
    – Serum albumin ≥ 25 g/L (2.5 g/dL)
    Serum bilirubin ≤ 1.5 × ULN, with the following exception:
    Patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN
    – For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 × ULN
    – AST, ALT, and ALP ≤ 2.5 × ULN, with the following exceptions:
    Patients with documented liver metastases: AST and ALT ≤ 5 × ULN
    Patients with documented liver or bone metastases: ALP ≤ 5 × ULN