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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of combination of atezolizumab (ATZ), cobimetinib and vemurafenib compared with combination of ATZ placebo, cobimetinib and vemurafenib in participants with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

Official Title

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Keywords

Melanoma Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age greater than or equal to (>/=) 18 years
  • Females of child bearing potential and males with female partners must and use of contraceptive methods with a failure rate of less than or equal to (

  • Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
  • Naive to prior systemic anti-cancer therapy for melanoma (example: chemotherapy,hormonal therapy, targeted therapy, immunotherapy, or other biologic therapies)except adjuvant treatment with interferon (IFN), interleukin (IL)-2, or vaccine therapies or herbal therapies
  • Documentation of BRAFv600 mutation-positive status in melanoma tumor tissue (archival or newly obtained) through use of a clinical mutation test approved by the local health authority
  • Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1
  • Measurable disease according to RECIST v1.1
  • Life expectancy>/=18 weeks
  • For participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to(

  • For participants receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 28 days immediately preceding initiation of study treatment

You CAN'T join if...

Cancer-Related Exclusion Criteria:

  • Major surgical procedure within 4 weeks prior study treatment initiation
  • Traumatic injury or palliative radiotherapy within 2 weeks prior study treatment initiation
  • Active malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC),resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast,in situ prostate cancer, limited-stage bladder cancer, or other curatively treated malignancies from which the participant has been disease-free for at least 3 years

Ocular Exclusion Criteria:

  • History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration

Cardiac Exclusion Criteria:

  • History of clinically significant cardiac dysfunction
  • Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or below 50%

Central Nervous System (CNS) Exclusion Criteria:

  • Untreated or actively progressing CNS lesions (carcinomatous meningitis)
  • History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm); or leptomeningeal metastatic disease; or intracranial hemorrhage

Additional Exclusion Criteria:

  • Current severe, uncontrolled systemic disease (including, but not limited to,clinically significant cardiovascular, pulmonary, or renal disease) other than cancer
  • History of malabsorption or other clinically significant metabolic dysfunction
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (example:bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • History of autoimmune disease
  • Known clinically significant liver disease, inherited liver disease and active viral disease
  • Active tuberculosis
  • Treatment with therapeutic oral or intravenous (IV) antibiotics; or with a live,attenuated vaccine; or systemic immunosuppressive medication
  • Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab, cobimetinib, or vemurafenib formulations

Locations

  • California Pacific Medical Center - Pacific Campus not yet accepting patients
    San Francisco, California, 94115, USA
  • Sutter Pacific Medical Foundation withdrawn
    Santa Rosa, California, 95403, USA
  • Stanford Comprehensive Cancer Center not yet accepting patients
    Stanford, California, 94305, USA
  • UC Irvine Medical Center not yet accepting patients
    Orange, California, 92868, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02908672
Phase
Phase 3
Study Type
Interventional
Last Updated
March 2017
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