Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies Clinical Trial

— ImmunEO  

Official title:

Impact of Immune Checkpoint Inhibitor Therapy on Type 2 Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609930
• Other study ID #: RECHMPL20_0583
• Status: Completed
• Start date: October 30, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to determine the impact of anti-checkpoint immunotherapy on type 2 inflammation via a retrospective analysis of % eosinophilia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Electronic patient file "DxCare" at the University Hospitals of Montpellier

• Patient has received anti-PD-1 immunotherapy --AND/OR -- anti-PD-L1 immunotherapy according to central pharmacy records

Exclusion Criteria:

• No mention of % eosinophilia in the patient file

Related Conditions & MeSH terms

• Inflammation
• Patients Recieving Anti-PD-1 or Anti-PD-L1 Immunotherapies

Intervention

Drug:
• Anti-PD-1 or anti-PD-L1
Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1		Before treatment (before day 0) versus after (15 days)
Primary	Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1		Before treatment (before day 0) versus after (1 month)
Primary	Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1		Before treatment (before day 0) versus after (3 months)
Primary	Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1		Before treatment (before day 0) versus after (6 months)
Primary	Change in % eosinophilia after initiation of anti-PD-1 and/or anti-PD-L1		Before treatment (before day 0) versus after (12 months)
Secondary	Indication leading to anti-PD-1 and/or anti-PD-L1 immunotherapies	Name of pathology	Day 0
Secondary	Age (years)		Day 0
Secondary	Sex (male/female)		Day 0