Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT03448666
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.
Study:
NCT03448666
Study Brief:
Protocol Section:
NCT03448666