Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727904
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-02-06
Brief Title:
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma
Sponsor:
Iovance Biotherapeutics Inc
Organization:
Iovance Biotherapeutics Inc
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Open-label Parallel Group Treatment Study to Assess the Efficacy and Safety of the Lifileucel LN-144 Autologous Tumor Infiltrating Lymphocytes TIL Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated Unresectable or Metastatic Melanoma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05398640
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
This is a Phase 3 multicenter open-label randomized parallel group treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated unresectable or metastatic melanoma Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease PD will be offered lifileucel monotherapy in an optional crossover period
Detailed Description:
The study will enroll participants with unresectable or metastatic melanoma Stage IIIC IIID or IV per the American Joint Committee on Cancer AJCC staging system who have had no prior therapy for metastatic disease Previous adjuvantneoadjuvant therapy with a single line of protooncogene B-Raf BRAF inhibitor with or without a mitogen-activated protein kinase MEK inhibitor PD-1 inhibitor or cytotoxic T-lymphocyte-associated antigen-4 CTLA-4 inhibitor is allowed provided such treatment was completed 6 months before progression to metastatic disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TILVANCE | OTHER | Iovance Biotherapeutics Inc | None |
| TILVANCE-301 | OTHER | None | None |