A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab and Bevacizumab, with and without Tiragolumab, In Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Conditions

Hepatocellular Carcinoma (HCC)

Brief summary

Investigator-assessed PFS, OS

Detailed description

Investigator-assessed confirmed ORR, Investigator-assessed DOR, Investigator-assessed PFS rate at 6 and 12 months, OS rate at 1 and 2 years, Investigator-assessed PFS, confirmed ORR, and DOR as determined by the investigator according to HCC mRECIST, TTCD, defined as change from baseline in GHS/QoL, Physical Functioning, and Role Functioning, as assessed through use of the EORTC QLQ-C30, Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) grading scale, Severity for cytokine release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale, Serum concentration of atezolizumab and tiragolumab at specified timepoints, Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab after treatment, Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab after treatment

Related papers

No related papers found yet.

Interventions

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGPlacebo Tiragolumab

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGTiragolumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Investigator-assessed PFS, OS	—

Secondary

Measure	Time frame
Investigator-assessed confirmed ORR, Investigator-assessed DOR, Investigator-assessed PFS rate at 6 and 12 months, OS rate at 1 and 2 years, Investigator-assessed PFS, confirmed ORR, and DOR as determined by the investigator according to HCC mRECIST, TTCD, defined as change from baseline in GHS/QoL, Physical Functioning, and Role Functioning, as assessed through use of the EORTC QLQ-C30, Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) grading scale, Severity for cytokine release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale, Serum concentration of atezolizumab and tiragolumab at specified timepoints, Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab after treatment, Prevalence of ADAs to atezolizu	—

Measure

Time frame

Investigator-assessed confirmed ORR, Investigator-assessed DOR, Investigator-assessed PFS rate at 6 and 12 months, OS rate at 1 and 2 years, Investigator-assessed PFS, confirmed ORR, and DOR as determined by the investigator according to HCC mRECIST, TTCD, defined as change from baseline in GHS/QoL, Physical Functioning, and Role Functioning, as assessed through use of the EORTC QLQ-C30, Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) grading scale, Severity for cytokine release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading scale, Serum concentration of atezolizumab and tiragolumab at specified timepoints, Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and incidence of ADAs to tiragolumab after treatment, Prevalence of ADAs to atezolizu

—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed