Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05775159
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-03-02
Brief Title:
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Open-Label Multi-Drug Multi-Center Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer GEMINI-Hepatobiliary
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
GEMINI-Hepatobiliary study will assess the efficacy safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors
Detailed Description:
This Phase II open-label uncontrolled multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy MONO andor in combination with anticancer agents COMBO in participants with advanced hepatobiliary cancer eg HCC BTC etc
This study has a modular design with independent substudies In Substudy 1 Volrustomig and Rilvegostomig will be evaluated as monotherapy andor in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC
In Substudy 2 the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced BTC who have not received previous treatment for advancedmetastatic disease
This study has a modular design with independent substudies In Substudy 1 Volrustomig and Rilvegostomig will be evaluated as monotherapy andor in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC
In Substudy 2 the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 60 evaluable participants with advanced BTC who have not received previous treatment for advancedmetastatic disease
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?:
None
Is an FDA AA801 Violation?:
None