Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04540211
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2020-09-03
Brief Title:
A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced Unresectable Recurrent or Metastatic Esophageal Carcinoma
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced Unresectable Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKYSCRAPER-08
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin PC compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced unresectable recurrent or metastatic esophageal carcinoma EC Participants will be randomized in a 11 ratio to receive one of the following treatment regimens during induction phase
Arm A Atezolizumab plus Tiragolumab and PC Arm B Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase participants will continue maintenance therapy with either atezolizumab plus tiragolumab Arm A or atezolizumab matching placebo plus tiragolumab matching placebo Arm B
Arm A Atezolizumab plus Tiragolumab and PC Arm B Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase participants will continue maintenance therapy with either atezolizumab plus tiragolumab Arm A or atezolizumab matching placebo plus tiragolumab matching placebo Arm B
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None