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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 BRAF V600 Wild-Type Melanoma

Primary Efficacy Objective: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of PFS by independent review Primary Endpoint: PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first Secondary Efficacy Objectives: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by investigator-assessed PFS To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by objective response rate To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by DCR To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by DOR To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by OS and 2-year landmark OS To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the change from baseline in HRQoL Secondary Endpoints: PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first Objective response, defined as a complete response or a partial response on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator through use of RECIST v1.1 DCR, defined as the proportion of patients with a complete response, a partial response, or stable disease at 16 weeks Duration of objective response, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first OS, defined as the time from randomization to death from any cause Two-year landmark survival, defined as survival at 2 years The change from baseline in HRQoL scores, as assessed through use of the two-item GHS/QoL subscale of the EORTC QLQ-C30, at specified time points while receiving treatment Exploratory Efficacy Objectives: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the investigator, according to immunemodified RECIST To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by change from baseline in functioning and commonly reported symptoms Exploratory Endpoints: Objective response according to investigator-assessed immune-modified RECIST DOR according to investigator-assessed immune-modified RECIST PFS according to investigator-assessed immune-modified RECIST Change from baseline in HRQoL, functioning and commonly reported symptoms (insomnia, pain, and fatigue), as assessed through use of the EORTC QLQ-C30 GHS, functioning and symptom scales, at specified time points, including progression, treatment discontinuation and post-study treatment The number and proportion of patients who improve, remained stable, and worsen from baseline as measured by the EORTC QLQ-C30 GHS, functioning, and symptom scales, at specified time points, including progression, treatment discontinuation and post-study treatment Safety Objective: To evaluate the safety of cobimetinib plus atezolizumab compared with pembrolizumab Safety Endpoints: Occurrence and severity of adverse events, with severity determined through use of NCI CTCAE v4.0 Change from baseline in selected vital signs Change from baseline in selected clinical laboratory test results Pharmacokinetic Objective: To characterize the cobimetinib and atezolizumab pharmacokinetics when administered in combination in this patient population

Primary Efficacy Objective: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the primary endpoint of PFS by independent review Primary Endpoint: PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by an IRC according to RECIST v1.1, or death from any cause, whichever occurs first Secondary Efficacy Objectives: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by investigator-assessed PFS To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by objective response rate To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by DCR To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by DOR To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by OS and 2-year landmark OS To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the change from baseline in HRQoL Secondary Endpoints: PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first Objective response, defined as a complete response or a partial response on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator through use of RECIST v1.1 DCR, defined as the proportion of patients with a complete response, a partial response, or stable disease at 16 weeks Duration of objective response, defined as the time from the first occurrence of a documented objective response to disease progression, as determined by the investigator through use of RECIST v1.1, or death from any cause, whichever occurs first OS, defined as the time from randomization to death from any cause Two-year landmark survival, defined as survival at 2 years The change from baseline in HRQoL scores, as assessed through use of the two-item GHS/QoL subscale of the EORTC QLQ-C30, at specified time points while receiving treatment Exploratory Efficacy Objectives: To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by the investigator, according to immunemodified RECIST To evaluate the efficacy of cobimetinib plus atezolizumab compared with pembrolizumab, as measured by change from baseline in functioning and commonly reported symptoms Exploratory Endpoints: Objective response according to investigator-assessed immune-modified RECIST DOR according to investigator-assessed immune-modified RECIST PFS according to investigator-assessed immune-modified RECIST Change from baseline in HRQoL, functioning and commonly reported symptoms (insomnia, pain, and fatigue), as assessed through use of the EORTC QLQ-C30 GHS, functioning and symptom scales, at specified time points, including progression, treatment discontinuation and post-study treatment The number and proportion of patients who improve, remained stable, and worsen from baseline as measured by the EORTC QLQ-C30 GHS, functioning, and symptom scales, at specified time points, including progression, treatment discontinuation and post-study treatment Safety Objective: To evaluate the safety of cobimetinib plus atezolizumab compared with pembrolizumab Safety Endpoints: Occurrence and severity of adverse events, with severity determined through use of NCI CTCAE v4.0 Change from baseline in selected vital signs Change from baseline in selected clinical laboratory test results Pharmacokinetic Objective: To characterize the cobimetinib and atezolizumab pharmacokinetics when administered in combination in this patient population