TriangleNCT02908672 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-07-20
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1
Percentage of Participants With Objective Response (OR), as Determined by Investigator Using RECIST V1.1
Duration of Response (DOR), as Determined by Investigator Using RECIST v1.1
Overall Survival (OS)
Percentage of Participants Who Have Survived at 2 Years
Time to Deterioration in Global Health Status (GHS) Determined Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
Time to Deterioration in Physical Functioning (PF) Determined Using EORTC QLQ-C30 Scale Score
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serum Concentration of Atezolizumab
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Plasma Concentration of Cobimetinib Dose: 60 mg
Plasma Concentration of Vemurafenib
Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
- intervention Names
- Drug: Atezolizumab
- Drug: Cobimetinib
- Drug: Vemurafenib
- Drug: Vemurafenib Placebo
- label
- Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- type
- EXPERIMENTAL
- description
- Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.
- intervention Names
- Drug: Atezolizumab Placebo
- Drug: Cobimetinib
- Drug: Vemurafenib
- label
- Atezolizumab Placebo + Cobimetinib + Vemurafenib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- description
- Will be administered as per the schedule described in individual arm.
- name
- Atezolizumab
- type
- DRUG
- arm Group Labels
- Atezolizumab Placebo + Cobimetinib + Vemurafenib
- description
- Will be administered as per the schedule described in individual arm.
- name
- Atezolizumab Placebo
- type
- DRUG
- arm Group Labels
- Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- Atezolizumab Placebo + Cobimetinib + Vemurafenib
- description
- Will be administered as per the schedule described in individual arm.
- name
- Cobimetinib
- type
- DRUG
- arm Group Labels
- Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- Atezolizumab Placebo + Cobimetinib + Vemurafenib
- description
- Will be administered as per the schedule described in individual arm.
- name
- Vemurafenib
- type
- DRUG
- arm Group Labels
- Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib Placebo
- description
- Will be administered as per the schedule described in individual arm.
- name
- Vemurafenib Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 514
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm).
- measure
- Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)
- secondary Outcomes
- description
- PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the IRC according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 mm.
- measure
- PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)
- description
- OR rate was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
- measure
- Percentage of Participants With Objective Response (OR), as Determined by Investigator Using RECIST V1.1
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 56 months)
- description
- DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 mm. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
- measure
- Duration of Response (DOR), as Determined by Investigator Using RECIST v1.1
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 56 months)
- description
- OS was defined as the time from randomization to death from any cause.
- measure
- Overall Survival (OS)
- time Frame
- Baseline up to death due to any cause (up to approximately 85 months)
- description
- Percentage of participants with OS which was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate 2-year landmark survival rate. The 95% CI of landmark survival rate was calculated using the standard error derived from Greenwood's formula.
- measure
- Percentage of Participants Who Have Survived at 2 Years
- time Frame
- 2 years
- description
- Time to deterioration in GHS/health related quality of life (HRQoL) was defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL.
- measure
- Time to Deterioration in Global Health Status (GHS) Determined Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)
- description
- Time to deterioration in PF = time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed PF scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet). PF are scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level, functioning/support.
- measure
- Time to Deterioration in Physical Functioning (PF) Determined Using EORTC QLQ-C30 Scale Score
- time Frame
- Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)
- description
- An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. All AEs were reported until 30 days and SAEs until 90 days after the final dose of study treatment or until initiation of subsequent anti-cancer therapy, whichever occurred first.
- measure
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- time Frame
- Up to approximately 85 months
- measure
- Serum Concentration of Atezolizumab
- time Frame
- Pre-infusion Day 1 of Cycles 1-4; 30 minutes post-infusion Day 1 of Cycles 1 and 4; at Atezolizumab discontinuation (up to approximately 33 months) (1 Cycle = 28 days)
- measure
- Plasma Concentration of Cobimetinib Dose: 20/40 mg
- time Frame
- Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)
- measure
- Plasma Concentration of Cobimetinib Dose: 60 mg
- time Frame
- Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)
- measure
- Plasma Concentration of Vemurafenib
- time Frame
- Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)
Full study description
- brief 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.
Source references
- references
- citation
- Li SN, Wan X, Peng LB, Li YM, Li JH. Cost-effectiveness of immune checkpoint inhibition and targeted treatment in combination as adjuvant treatment of patient with BRAF-mutant advanced melanoma. BMC Health Serv Res. 2023 Jan 18;23(1):49. doi: 10.1186/s12913-023-09058-7.
- pmid
- 36653848
- type
- DERIVED
- citation
- Ascierto PA, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Zhukova N, Schachter J, Yan Y, Caro I, Hertig C, Xue C, Kusters L, McArthur GA, Gutzmer R. Overall survival with first-line atezolizumab in combination with vemurafenib and cobimetinib in BRAFV600 mutation-positive advanced melanoma (IMspire150): second interim analysis of a multicentre, randomised, phase 3 study. Lancet Oncol. 2023 Jan;24(1):33-44. doi: 10.1016/S1470-2045(22)00687-8. Epub 2022 Nov 29.
- pmid
- 36460017
- type
- DERIVED
- citation
- Robert C, Lewis KD, Gutzmer R, Stroyakovskiy D, Gogas H, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Caro I, Forbes H, Shah K, Yan Y, Li H, McArthur GA, Ascierto PA. Biomarkers of treatment benefit with atezolizumab plus vemurafenib plus cobimetinib in BRAFV600 mutation-positive melanoma. Ann Oncol. 2022 May;33(5):544-555. doi: 10.1016/j.annonc.2022.01.076. Epub 2022 Feb 4.
- pmid
- 35131452
- type
- DERIVED
- citation
- de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.
- pmid
- 33476492
- type
- DERIVED
- citation
- Gutzmer R, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Manikhas GM, Yan Y, Huang KC, Uyei A, McNally V, McArthur GA, Ascierto PA. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAFV600 mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Jun 13;395(10240):1835-1844. doi: 10.1016/S0140-6736(20)30934-X.
- pmid
- 32534646
- type
- DERIVED
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