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

ConditionSolid Tumor, Adult
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Oscar Lambret

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • ImmuCCo Cohort

    Other intervention

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

Treatment groups

651 Participants
are divided into 1 treatment group
Group A: ImmuCCo CohortOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Number of patients treated by immunotherapy and registered in the database

Time frame
5 years

Secondary outcomes

1

Overall Survival

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

Time frame
6 years
2

Progression-Free Survival

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.

Time frame
6 years
3

Tumor response

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.

Time frame
6 years
4

Co-medications

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

Time frame
6 years

Other outcomes

Sponsors and contacts

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Centre Oscar Lambret

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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