Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2023-12-22
Brief Title:
PEMBRO-K Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in NSCLC
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
PEMBRO-K Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in Non-small Cell Bronchopulmonary Cancer NSCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
PEMBRO-K
Brief Summary:
Solid cancers and their therapeutic management remain a major public health problem due to their increasing prevalence and associated mortality Among solid cancers lung cancer ranks 4th among incident cancers The prognosis remains poor 33117 deaths were recorded in France in 2018 Two histological forms of bronchopulmonary cancer are distinguished non-small cell lung cancers NSCLC which represent 85 of bronchopulmonary cancer and small cell lung cancers The most common forms of NSCLC are adenocarcinoma squamous cell carcinoma and large cell carcinoma
The emergence of new so-called targeted therapies has considerably modified the management and prognosis of oncology patients and in particular of patients with NSCLC These new molecules were developed following the molecular characterization of tumors on the one hand and on the other hand the characterization of the role of immunity in anti-tumor defense particularly the Programmed Death receptor pathway 1 PD-1 Blocking this pathway restores the anti-tumor potential of these lymphocytes Pembrolizumab is a humanized monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the Programmed Death Ligand-1 PDL1 and Programmed Death Ligand-2 PDL2 expressed by tumor cells but also by cells in the microenvironment tumor and by antigen-presenting cells Pembrolizumab thus potentiates T cell responses including anti-tumor responses by blocking the binding of PD-1 with PDL1 and PDL2
Pembrolizumab currently has marketing authorization MA for the treatment of NSCLC Despite therapeutic progress due among other things to the emergence of anti-PD-1 antibodies including pembrolizumab the prognosis of NSCLC remains poor and the use of pembrolizumab is sometimes limited by the occurrence of adverse effects
The pharmacokinetics of pembrolizumab was studied pre-marketing in patients with melanoma NSCLC or metastatic or unresectable carcinomas However there are no data relating to the pharmacokinetic PK clinical response pharmacodynamic PD relationship of pembrolizumab in real life No prospective pharmacological study has in fact been published to date especially in patients treated as part of the management of NSCLC The absence of such studies - in real life - constitutes a pitfall given the existence of a possible association between PK data and the clinical response andor toxicity of pembrolizumab
The emergence of new so-called targeted therapies has considerably modified the management and prognosis of oncology patients and in particular of patients with NSCLC These new molecules were developed following the molecular characterization of tumors on the one hand and on the other hand the characterization of the role of immunity in anti-tumor defense particularly the Programmed Death receptor pathway 1 PD-1 Blocking this pathway restores the anti-tumor potential of these lymphocytes Pembrolizumab is a humanized monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with the Programmed Death Ligand-1 PDL1 and Programmed Death Ligand-2 PDL2 expressed by tumor cells but also by cells in the microenvironment tumor and by antigen-presenting cells Pembrolizumab thus potentiates T cell responses including anti-tumor responses by blocking the binding of PD-1 with PDL1 and PDL2
Pembrolizumab currently has marketing authorization MA for the treatment of NSCLC Despite therapeutic progress due among other things to the emergence of anti-PD-1 antibodies including pembrolizumab the prognosis of NSCLC remains poor and the use of pembrolizumab is sometimes limited by the occurrence of adverse effects
The pharmacokinetics of pembrolizumab was studied pre-marketing in patients with melanoma NSCLC or metastatic or unresectable carcinomas However there are no data relating to the pharmacokinetic PK clinical response pharmacodynamic PD relationship of pembrolizumab in real life No prospective pharmacological study has in fact been published to date especially in patients treated as part of the management of NSCLC The absence of such studies - in real life - constitutes a pitfall given the existence of a possible association between PK data and the clinical response andor toxicity of pembrolizumab
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02527-38 | OTHER | n IdRCB | None |