Solid Tumor, AdultImmuCCoNCT05223608
Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
A study testing ImmuCCo Cohort in people with Solid Tumor, Adult, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- ImmuCCo Cohort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 651 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2022to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Oscar Lambret
Lille, Hauts-de-France, 59
Alexandra FORESTIER, 03 20 29 59 59, a-forestier@o-lambret.fr
Alexandra FORESTIER
About this study
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.
Read the detailed 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.
- Conditions
- Solid Tumor, Adult
- Being tested
- ImmuCCo Cohort
- Keywords
- Prospective cohort, Clinic-biologic database, Solid tumor, Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmuCCo CohortOther
Blood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ImmuCCo Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated by immunotherapy and registered in the database.
Number of patients treated by immunotherapy and registered in the database
Measured: 5 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 6 years
Co-medications
All comedications given during the course of the study will be compiled
Measured: 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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start3 Mar 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Observational study model with additional blood samples and urine collection
- Masking
- None (open label)
- Enrolment
- 651 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra FORESTIER, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223608
- Sponsor's protocol ID
- ImmuCCo-1905
- Other IDs
- 2020-A00854-35
- Acronym
- ImmuCCo
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2022
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy
- ClinicalTrials.gov ID
- NCT05223608
- Acronym / sponsor ID
- ImmuCCo / ImmuCCo-1905
- Conditions
- Solid Tumor, Adult
- Keywords
- Prospective cohort, Clinic-biologic database, Solid tumor, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 651 participants (estimated)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational study model with additional blood samples and urine collection
| Arm | Type | Receives |
|---|---|---|
| ImmuCCo Cohort | Other | Other: ImmuCCo CohortBlood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmuCCo CohortBlood sampling at initiation of immunotherapy, at the first tumor assessment, in case of severe toxicity. Urine collection at initiation of immunotherapy. | Other | ImmuCCo Cohort |
Primary outcome
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
5 secondary outcomes
Overall Survival
Time frame: 6 years
Progression-Free Survival
Time frame: 6 years
Tumor response
Time frame: 6 years
Co-medications
Time frame: 6 years
Toxicity of immunotherapy
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra FORESTIER, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImmuCCo Cohort in people with Solid Tumor, Adult, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien THERY (+330320295918, promotion@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients treated by immunotherapy and registered in the database. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.