A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma
Status: | Active, not recruiting |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/15/2019 |
Start Date: | January 13, 2017 |
End Date: | July 29, 2023 |
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
This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study
designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib
+ vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously
untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.
designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib
+ vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously
untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.
Inclusion Criteria:
- 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 (=)1% per year is
required during treatment and for 6 months post treatment. Males should not expose
pregnant partners to sperm and refrain from donating sperm for 6 months post
treatment. Women must refrain from donating eggs during this same period
- 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 (must be outside central nervous system
(CNS))
- 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
(=) 1.5*upper limit of normal (ULN) within 28 days prior to initiation of study
treatment
- For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
and stable INR during the 28 days immediately preceding initiation of study treatment
Exclusion Criteria:
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 are excluded, 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 any 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:
- Uncontrolled diabetes or symptomatic hyperglycemia
- 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
- Active or history of autoimmune disease or immune deficiency
- 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
- Any grade >/=3 hemorrhage or bleeding event within 4 weeks prior to initiation of
study treatment
- History of stroke, reversible ischemic neurological defect, or transient ischemic
attack within 6 months prior to initiation of study treatment
We found this trial at
21
sites
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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2316 East Meyer Boulevard
Kansas City, Missouri 64132
Kansas City, Missouri 64132
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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925 Chestnut Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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