Melanoma Clinical Trial
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
Summary
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.
Eligibility Criteria
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
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There are 114 Locations for this study
Birmingham Alabama, 35233, United States
Tempe Arizona, 85284, United States
Springdale Arkansas, 72762, United States
Orange California, 92868, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32824, United States
Park Ridge Illinois, 60068, United States
Bethlehem Pennsylvania, 18015, United States
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Melbourne Victoria, 3000, Australia
Murdoch Western Australia, 6150, Australia
Graz , 8030, Austria
Innsbruck , 6020, Austria
Wien , 1090, Austria
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Wilrijk , 2610, Belgium
Rio De Janeiro RJ, 22290, Brazil
Porto Alegre RS, 90035, Brazil
Florianopolis SC, 88020, Brazil
Sao Paulo SP, 01246, Brazil
São Paulo SP, 01321, Brazil
Calgary Alberta, T2N 4, Canada
Hamilton Ontario, L8V 5, Canada
London Ontario, N6A 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4X 1, Canada
Quebec , G1J 1, Canada
Bordeaux , 33075, France
Dijon , 21079, France
La Tronche , 38700, France
Lille , 59037, France
Montpellier , 34295, France
Nantes , 44093, France
Reims , 51092, France
Rennes , 35042, France
Rouen , 76031, France
Villejuif , 94805, France
Berlin , 12203, Germany
Buxtehude , 21614, Germany
Erfurt , 99089, Germany
Erlangen , 91054, Germany
Essen , 45147, Germany
Göttingen , 37075, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Kiel , 24105, Germany
Köln , 50937, Germany
Leipzig , 04103, Germany
Lübeck , 23538, Germany
Mainz , 55131, Germany
München , 80337, Germany
Münster , 48157, Germany
Quedlinburg , 06484, Germany
Regensburg , 93053, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Athens , 115 2, Greece
Pireaus , 185 4, Greece
Budapest , 1122, Hungary
Szeged , 6720, Hungary
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Petach Tikva , 49414, Israel
Ramat-Gan , 52656, Israel
Napoli Campania, 80131, Italy
Meldola Emilia-Romagna, 47014, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Roma Lazio, 00144, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Candiolo Piemonte, 10060, Italy
Bari Puglia, 70124, Italy
Siena Toscana, 53100, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Rotterdam , 3015A, Netherlands
Auckland , 1023, New Zealand
Newtown , 6021, New Zealand
Palmerston North , 4442, New Zealand
Tauranga , 3112, New Zealand
Gda?sk , 80-21, Poland
Kraków , 31-11, Poland
Lublin , 20-09, Poland
Pozna? , 60-78, Poland
Warszawa , 02-78, Poland
Wroc?aw , 53-41, Poland
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow Moskovskaja Oblast, 11547, Russian Federation
Saint-Petersburg Sankt Petersburg, , Russian Federation
Sankt-peterburg Sankt Petersburg, 19825, Russian Federation
Pamplona Navarra, 31008, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Madrid , 28046, Spain
Sevilla , 41071, Spain
Valencia , 46009, Spain
Valencia , 46014, Spain
Zaragoza , 50009, Spain
Bristol , BS2 8, United Kingdom
Glasgow , G12 0, United Kingdom
Ipswich , IP4 5, United Kingdom
Leeds , LS9 7, United Kingdom
London , SE1 9, United Kingdom
New Castle Upon Tyne , NE7 7, United Kingdom
Swansea , SA2 8, United Kingdom
Truro , TR1 3, United Kingdom
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