Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT02676869
Status:
COMPLETED
Last Update Posted:
2019-12-18
First Post:
2016-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma
Sponsor:
Immutep Australia Pty. Ltd.
Organization:
Study Overview
Official Title:
A Multicentre, Open Label, Dose Escalation, Phase 1 Study in Patients With Unresectable or Metastatic Melanoma Receiving IMP321 (LAG-3Ig Fusion Protein-eftilagimod Alpha) as an Adjunctive Therapy to Anti-PD-1 Therapy With Pembrolizumab
Status:
COMPLETED
Status Verified Date:
2019-12
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:
TACTI-mel
Brief Summary:
The purpose of this study is to determine the safety, tolerability and recommended phase 2 dose of a new drug, known as IMP321, in combination with pembrolizumab when given to patients with unresectable or metastatic melanoma.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: