Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT06651593
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-08
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 response/survival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors
* To evaluate the association of biomarkers with response/survival 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 response/survival and resistance to the combination of SAR444881 and cemiplimab in participants with solid tumors
* To evaluate the association of biomarkers with response/survival 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:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-08852 | OTHER | NCI-CTRP Clinical Registry | View |