Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651593
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study possible biomarkers that may be related to how SAR444881 works either alone or when combined with cemiplimab in participants with solid tumors
Detailed Description:
Primary Objective
To identify biomarkers
Related to the mechanism of action of SAR444881 alone and in combination with cemiplimab in participants with solid tumors
Predictive of responsesurvival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors
To evaluate the association of biomarkers with responsesurvival and resistance
Objective response rate ORR
Clinical benefit rate CBR
Progression-free survival PFS
Overall survival OS
Secondary Objectives
To evaluate the efficacy of the SAR444881 and cemiplimab combination
To determine the safety and tolerability of the SAR444881 and cemiplimab combination
To identify biomarkers
Related to the mechanism of action of SAR444881 alone and in combination with cemiplimab in participants with solid tumors
Predictive of responsesurvival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors
To evaluate the association of biomarkers with responsesurvival and resistance
Objective response rate ORR
Clinical benefit rate CBR
Progression-free survival PFS
Overall survival OS
Secondary Objectives
To evaluate the efficacy of the SAR444881 and cemiplimab combination
To determine the safety and tolerability of the SAR444881 and cemiplimab combination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None