Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-03 @ 6:34 PM
Study NCT ID:
NCT03448666
Status:
WITHDRAWN
Last Update Posted:
2024-09-23
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ECT-Pembrolizumab in Patients With Unresectable Melanoma With Superficial or Superficial and Visceral Metastases
Sponsor:
European Institute of Oncology
Organization:
Study Overview
Official Title:
A Phase II, Multicentric, Open Label, Non-randomized, Interventional Study of Pembrolizumab in Combination With Electrochemotherapy in Patients With Unresectable Melanoma With Superficial or Superficial and Visceral Metastases
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no financial support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 multicenter, open label, non-randomized, interventional study enrolling 53 patients.The objectives and purposes of the clinical study described herein are to determine if concomitant Pembrolizumab (Keytruda) and ECT treatments are safe and able to improve local and systemic response rates.ECT will be performed with the CLINIPORATOR and a single IV dose of Bleomycin
Detailed Description:
ECT induces immunogenic cell death of cancer cells with a more efficient antigen presentation of tumor-derived antigens by APCs to T-cells, particularly CD8+ antigen-specific T cells. Anti-PD-1 mAb reverts T-cell exhaustion induced by PD-1/PD-L1 and PD-L2 engagement on CD8+ T cells. Moreover, it may also be beneficial in the priming phase of the antitumor immune responses, inducing long-lived tumor antigen-specific CD8+ T-cell effectors.
The main hypothesis is to establish if concomitant treatment of Pembrolizumab and ECT is able to lead to a 20% increase of the ORR using as a reference the proportion of success available in the literature for Pembrolizumab.
The investigators will perform a proteomic analysis of sera of treated patients, collected before and after treatments, with particular emphasis on cytokines and chemokines, to evaluate possible markers associated with a better clinical outcome.
The main hypothesis is to establish if concomitant treatment of Pembrolizumab and ECT is able to lead to a 20% increase of the ORR using as a reference the proportion of success available in the literature for Pembrolizumab.
The investigators will perform a proteomic analysis of sera of treated patients, collected before and after treatments, with particular emphasis on cytokines and chemokines, to evaluate possible markers associated with a better clinical outcome.
Study Oversight
Has Oversight DMC:
False
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?: