Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT02889861
Status:
TERMINATED
Last Update Posted:
2020-07-27
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IMCgp100-401 Rollover Study
Sponsor:
Immunocore Ltd
Organization:
Study Overview
Official Title:
An Open-label, Multi-center, Rollover Study in Patients With Advanced Melanoma After Completing an IMCgp100 Clinical Study
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study).
Detailed Description:
IMCgp100-401 is a rollover study that is designed to provide continued access to IMCgp100 for eligible participants with advanced melanoma who have previously participated in an IMCgp100 study (parent study). Parent studies that are eligible for participants to continue to receive IMCgp100 in this rollover study must have completed and satisfied its primary endpoints or have been terminated by the Sponsor for reasons other than safety.
Eligible participants will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.
Eligible participants will have tolerated IMCgp100 for a minimum of 4 weeks of dosing without significant toxicities that would preclude further dosing in the opinion of the principal investigator or Sponsor.
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?: