solid tumour MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: atezolizumab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Atezolizumab
Current Sponsor code: Atezolizumab
Concentration unit: mg milligram(s)
Concentra
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 18 years old 2) ECOG performance status = 1 3) Must have histologically or cytologically confirmed solid tumour, eligible fortreatment with ICI as standard-of-care alone or in combination with another ICI (cohort 1), ICI with chemotherapy (cohort 2), or ICI with targeted therapy (cohort 3) with no restrictions on number of prior systemic therapies 4) All prior anti-cancer treatment-related toxicities (except alopecia) must be = Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at the time of enrolment 5) Serum pregnancy test (for subjects of childbearing potential) negative within 15 days prior to study medications administration 6) Women of childbearing potential must agree to use one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatments 7) Men with childbearing potential partner must agree to use condom during the course of this study and for at least 6 months after the last administration of the study treatments 8) Completion of all necessary screening procedures within 14 days prior to enrolment 9) Signed Informed Consent form (ICF) obtained prior to any study related procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 147 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 294
Exclusion criteria
Exclusion criteria: 1) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator’s opinion, may interfere with completion of the study 2) Participation in another clinical trial 3) Pregnant and/or lactating women 4) Patients already receiving ICI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this pilot study is to explore the value of immune markers present in blood in the purpose of identifying biomarkers for immune-related toxicities of checkpoint inhibitors.;Secondary Objective: Not applicable;Primary end point(s): Modification(s) in the immune blood markers including serum autoantibody level of treated subjects at three different time points during the treatment by ICI (early, mid time and late) and at the occurrence of irAEs as described below compared to baseline. Safety will be assessed: by the investigator(s) by using the adverse events reported during the study in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.;Timepoint(s) of evaluation of this end point: end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium
Contacts
Public ContactCTSU
Institut Jules Bordet
Outcome results
None listed