Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

Phase

N/A

Condition

Neoplasm Metastasis

Cancer

Treatment

ImmuCCo Cohort

Clinical Study ID

NCT05223608

ImmuCCo-1905

Ages > 18
All Genders

Study Summary

ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age ≥ 18 years
Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmedcell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, inthe Centre Oscar Lambret (COL)
In neo-adjuvant, adjuvant, recurrence or metastatic situation
Suffering from solid tumor histologically documented
Signed written informed consent
Patient covered by the French " "Social Security" regime If the patient is alreadyenrolled in clinical trial involving immunotherapy, the agreement of the sponsor ofthis new trial will be sought before his/her inclusion.

Exclusion

Exclusion Criteria:

Pregnant or breastfeeding women
Patient already treated by immunotherapy by immune checkpoint inhibitor
Person under guardianship
Inability to comply with medical follow-up of the trial (geographical, social orpsychic reasons)

Study Design

ImmuCCo Cohort

March 03, 2022

March 31, 2028

Study Description

The aim of this study is to establish a prospective clinic-biologic database of patients treated by immunotherapy. This database will allowed to carry out works (such as translational research) aiming at assessing immunotherapy in real life situation.

Other objectives of the study include:

Describe overall survival, progression-free survival, response to immunotherapy (in particular hyper-progression, pseudo-progression) considering the first tumor assessment and the best response, prolonged response
Identifying prognostic factors of overall survival, progression-free survival, hyper-progression, best response under immunotherapy
Describe AEs (Adverse Events) potentially associated with immunotherapy, their kinetics of appearance, from the start of treatment and after the end of treatment in order to assess the risk of delayed appearance
To identify factors associated with increased risk of severe adverse event (grade > 2 or leading to end of treatment) potentially related to immunotherapy, from the beginning of immunotherapy to 1 year after this start of the treatment, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
Identifying delayed adverse events potentially related to immunotherapy, occurring between 90 days and 1 year after the treatment discontinuation, in patients who received at least 4 doses or who stopped the treatment earlier (before 4 doses) due to toxicity.
To identify and describe rare toxicities
To evaluate the association between co-medications and disease evolution
To evaluate the association between co-medications and toxicities occurrence

Translational research objectives:

To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:
- Establishment of serum and plasma bank which will be used for diverse works;
- A systematic analysis of the lymphocyte profile
To study the impact of tabagism on efficacy and toxicity of immunotherapy from systematic collection of urinary cotinine.

Connect with a study center

Centre Oscar Lambret
Lille, Hauts-de-France 59
France
Active - Recruiting

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