Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04913220
Status:
TERMINATED
Last Update Posted:
2025-03-05
First Post:
2021-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Phase 1/2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR- 707) Combined With Cemiplimab for the Treatment of Participants With Advanced Unresectable or Metastatic Skin Cancers
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early discontinuation based on strategic sponsor decision not driven by any safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
* To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
* To assess other indicators of antitumor activity
* To assess the concentrations of SAR444245 when given in combination with cemiplimab
* To assess the immunogenicity of SAR444245
* To assess active concentrations of cemiplimab when given in combination with SAR444245
-To determine the antitumor activity of SAR444245 in combination with cemiplimab.
Secondary Objectives:
* To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab
* To assess other indicators of antitumor activity
* To assess the concentrations of SAR444245 when given in combination with cemiplimab
* To assess the immunogenicity of SAR444245
* To assess active concentrations of cemiplimab when given in combination with SAR444245
Detailed Description:
The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period \[max 35 cycles or until PD\], an end-of-treatment visit 30 days + 7 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or final cohort cut-off, whichever is earlier
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?:
None
Is an FDA AA801 Violation?: