Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04050436
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2019-08-02
Brief Title:
Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Sponsor:
Replimune Inc
Organization:
Replimune Inc
Study Overview
Official Title:
A Randomized Controlled Open-Label Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
CERPASS
Brief Summary:
To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC as assessed by overall response rate ORR and complete response rate CRR according to blinded independent review
Detailed Description:
RP1 is a selectively replication competent herpes simplex virus type 1HSV-1 This is a Phase 12 open-label multicenter repeat-dosing study of RP1 alone and in combination with nivolumab in patients with advanced malignancies and contains both single agent dose escalation dose expansion to include nivolumab and the combination in multiple Phase 2 cohorts in individual tumor types
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