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NCT Number: NCT05223608

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Oscar Lambret

Lille, Hauts-de-France, 59, France

Location status: Recruiting

Location contact

Alexandra FORESTIER

CONTACT

[email protected]

03 20 29 59 59

Alexandra FORESTIER

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ImmuCCo Cohort

Other

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

Primary outcomes

  1. Number of patients treated by immunotherapy and registered in the database.

    Time frame: 5 years

    Number of patients treated by immunotherapy and registered in the database

Secondary outcomes

  1. Overall Survival

    Time frame: 6 years

    Time between date of start of immunotherapy to date of death whatever the cause. Patients alive at last follow-up will be censored.

  2. Progression-Free Survival

    Time frame: 6 years

    Time between start of immunotherapy to date of disease progression or death whatever the cause. Alive, non-progressive patients at last follow-up will be censored.

  3. Tumor response

    Time frame: 6 years

    Tumor response will be based on the first tumor assessment performed during the immunotherapy. Objective response according to iRECIST (Response Evaluation Criteria in Solid Tumours for immunotherapy) criteria will be defined at the first tumor assessment and during the course of the treatment, meaning until disease progression of start of another systemic treatment.

    Responses will be: Complete response (iCR), partial response (iPR), stability (iSD), progression, or pseudo-progression. Confirmed progressive disease (iCPD) will be distinguished from pseudo-progression (iUPD) according to control images. Hyper-progression will be defined as a progression according to iRECIST criteria and a doubling of tumor growth rate.

    A prolonged tumor response will be defined as a progression free survival duration at least 3 time superior to median duration of progression free survival of patients of the study presenting the same disease.

  4. Co-medications

    Time frame: 6 years

    All comedications given during the course of the study will be compiled

  5. Toxicity of immunotherapy

    Time frame: 6 years

    All Adverse events occuring from the start of the immunotherapy to the follow-up performed on year after the end of the immunotherapy will be notified, whatever the grade and the relationship with immunotherapy, apart from those undoubtfully related to the disease or the progression of the disease.The AE will also be notified in case of start of a second line of treatment, apart from thos undoubtfully related to this second line of treatment. The main analysis will be done on AE potentially related to immunotherapy. The relationship will be evaluated by a medical expert of immunotherapy. AE will be graded according to CTCAE v5.0 classification. Patients who received less than 4 doses will be considered non-evaluable for this outcome apart from those who discontinued treatment because they had a toxicity. Each AE with a grade > 2 and/or leading to treatment discontinuation will be considered as severe.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien THERY

CONTACT

[email protected]

+330320295918

Marjane BELMIMOUN

CONTACT

[email protected]

+330320295918

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: ImmuCCo

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 4, 2022
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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