None listed
Conditions
Interventions
Cohort 1 (patients with PD-L1 non-positive tumors) Type of group
– Experimental arm (Arm A
40% chance): ipatasertib + atezolizumab + paclitaxel
– Experimental arm (Arm B
Cohort 2 (patients with PD-L1 positive tumors) Type of group
– Control arm (Arm B
50% chance): placebo (for ipatasertib) + atezolizumab + paclitaxel
Sponsors
F. Hoffmann La Roche Ltd / Genentech Inc,
Eligibility
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form(s) • Women or men, age ≥ 18 years at the time of signing the Informed Consent Form • Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator’s judgment. • Measurable disease according to RECIST v1.1 Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation. • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 • Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1. • Life expectancy of at least 6 months • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs. • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm. See protocol for more detail.
Exclusion criteria
Exclusion criteria: • Inability to comply with study and follow-up procedures • History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills • Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungal agents, and anti-viral agents) • Known HIV infection (there must be a negative HIV test at screening) • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis. • Current treatment with anti-viral therapy for HBV • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study. • Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib/placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later. See protocol for more detail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Investigator-assessed progression-free survival (PFS) after randomization, as determined locally according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. • Overall survival (OS). Measure:The primary efficacy objective for this study is to independently evaluate the efficacy of ipatasertib plus atezolizumab plus paclitaxel compared with control arm treatment in each cohort (i.e., Arm A vs. Arm C in Cohort 1 and Arm A vs. Arm B in Cohort 2), on the basis of the following co-primary endpoints: Timepoints:Throughout study. ; Outcome name:• Incidence and severity of adverse events, with severity determined by the investigator according to the NCI Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) • Change from baseline in targeted vital signs • Change from baseline in targeted clinical laboratory test results Measure:The safety objective for this study is to independently evaluate the safety of ipatasertib plus paclitaxel plus atezolizumab in each cohort, on the basis of the following endpoints: Timepoints:Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:− Objective response rate (ORR), as determined by the investigator according to RECIST v1.1 − Duration of response (DOR), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first − Clinical benefit rate (CBR), as determined by the investigator according to RECIST v1.1. Measure:To independently evaluate the efficacy of ipatasertib plus atezolizumab plus paclitaxel compared with control arm treatment in each cohort (i.e., Arm A vs. Arm C in Cohort 1 and Arm A vs. Arm B in Cohort 2) on the basis of the following endpoints: Timepoints:Throughout study. | — |
Countries
Argentina, Austria, Brazil, Canada, Costa Rica, Czech Republic, Hungary, India, Ireland, Italy, Mexico, Peru, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactLizeth Perez
ROCHE FARMA (PERU) S.A.
Outcome results
None listed