An interventional study of ImmuCCo Cohort in Solid Tumor, Adult, sponsored by Centre Oscar Lambret. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Centre Oscar Lambret · Not applicable, Interventional, and Treatment
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.
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:
Translational research objectives:
To identify biomarkers that might be associated with tumor response and/or toxicity of immunotherapy from:
Centre Oscar Lambret is the lead sponsor of 130 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
Other: ImmuCCo Cohort
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
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
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
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
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
Co-medications
All comedications given during the course of the study will be compiled
Time frame: 6 years
Toxicity of immunotherapy
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.
Time frame: 6 years
Started Mar 2022 (actual). Primary completion is estimated for Mar 2027, 60 months after the start.
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