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

Centre Oscar Lambret

Status: Enrolling

Conditions: Solid Tumor, Adult

Treatments: Other: ImmuCCo Cohort

Study type: Interventional

Funder types: Other

Identifiers

NCT05223608

ImmuCCo-1905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Beginning a first immunotherapy by immune checkpoint inhibitor - anti-PD1 (Programmed cell Death protein-1), anti-PDL1 (Programmed cell Death protein-1 ligand), anti-CTLA4 (Cytotoxic T-Lymphocyte associated protein 4), as monotherapy or in combination, in the 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 already enrolled in clinical trial involving immunotherapy, the agreement of the sponsor of this new trial will be sought before his/her inclusion.

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 or psychic reasons)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

ImmuCCo Cohort

Other group

Description:

Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.

Treatment:

Other: ImmuCCo Cohort