Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03638375
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2018-07-05
Brief Title:
TIL and Anti-PD1 in Metastatic Melanoma
Sponsor:
Leiden University
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Adoptive TIL Therapy With Low-dose IFN-alpha Plus Anti-PD1 in Metastatic Melanoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
ACTME
Brief Summary:
The ACTME study is an investigator initiated single center phase III clinical trial for patients with progressive unresectable stage III or stage IV melanoma The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha nivolumab and TIL The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe
Detailed Description:
The ACTME is an investigator initiated single center phase III clinical trial for patients with progressive unresectable stage III or stage IV melanoma
Patients are conditioned by low-dose IFN-alpha and treated with ACT and PD-1 antibodies With this approach the investigators hope to solve 4 of the most important aspects curtailing the efficacy of current immunotherapies in metastatic melanoma
1 the lack of sufficient numbers of activated tumor-reactive T cells in patients by providing ACT and
2 the inhibition of T-cell effector function through PD-1 signalling by administration of nivolumab as well as
3 the toxicity of high-dose IL-2 and
4 long term hospitalization of patients due to the conditioning-regimen used in most ACT protocols by replacing it with low-dose IFN-alpha treatment
The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha nivolumab and TIL
The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe in the first cohort of the phase I part of the trial
Patients are conditioned by low-dose IFN-alpha and treated with ACT and PD-1 antibodies With this approach the investigators hope to solve 4 of the most important aspects curtailing the efficacy of current immunotherapies in metastatic melanoma
1 the lack of sufficient numbers of activated tumor-reactive T cells in patients by providing ACT and
2 the inhibition of T-cell effector function through PD-1 signalling by administration of nivolumab as well as
3 the toxicity of high-dose IL-2 and
4 long term hospitalization of patients due to the conditioning-regimen used in most ACT protocols by replacing it with low-dose IFN-alpha treatment
The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha nivolumab and TIL
The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe in the first cohort of the phase I part of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None