Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT04916002
Status:
TERMINATED
Last Update Posted:
2025-12-05
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Phase 2 Study of Intratumoral Vidutolimod (CMP-001) in Combination With Intravenous Cemiplimab in Subjects With Selected Types of Advanced or Metastatic Cancer
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision related to study drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to learn if giving cemiplimab and vidutolimod together could be effective in treating advanced cancer. The main questions it aims to answer are:
* How many participants' cancers respond to vidutolimod together with cemiplimab?
* Is vidutolimod together with cemiplimab safe and well-tolerated?
* How well does vidutolimod together with cemiplimab treat participants' cancer?
Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.
* How many participants' cancers respond to vidutolimod together with cemiplimab?
* Is vidutolimod together with cemiplimab safe and well-tolerated?
* How well does vidutolimod together with cemiplimab treat participants' cancer?
Participants will receive trial treatment for up to 2 years. 30 days after stopping treatment, participants will have a follow-up visit. After that visit, the trial staff will continue to follow up with participants about every 3 months, until the trial ends.
Detailed Description:
Former Sponsor Checkmate Pharmaceuticals Note: Early termination planned on 31Oct2024 due to study drug supply
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-507344-36-01 | REGISTRY | EUCT Number | View |