Solid CancersMINER2NCT07427186
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer
A study testing Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable) in people with Solid Cancers, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers
- What is being tested?
- Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Aug 2026to 6 Aug 2041
- 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 at the time of study entry.
- Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
- Patient for whom a neo-adjuvant treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination with chemotherapy or other therapies has been decided.
- Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.
- Treatment with ICB not yet started.
- ECOG Performance status 0-2.
- Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Patient pregnant, or breast-feeding.
- Uveal melanoma
- Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
Jean-Pierre DELORD, MD, Professor, 05 31 15 55 00, delord.jean-pierre@iuct-oncopole.fr
- Not yet recruiting
Chu Rangueil
Toulouse, 31400
Nadim FARES, MD, 05 61 32 21 42, fares.n@chu-toulouse.fr
- Not yet recruiting
Hopital Larrey
Toulouse, 31400
Julien MAZIERES, MD, 05 67 77 18 37, mazieres.j@chu-toulouse.fr
About this study
This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). Patients with any of the following tumor types may be enrolled in the trial:
Non-Small Cell Lung Cancer (NSCLC), Head and neck cancer, Melanoma, Bladder cancer, Other tumor types when Immuno-Oncology agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
Read more
For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.
All included patients will be followed up for 5 years after baseline.
- Conditions
- Solid Cancers
- Being tested
- Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)
- Keywords
- Immunotherapy, tumor microenvironment, adaptive immune responses, Immune checkpoint blockade, tumor antigens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)Other
Blood samples will be collected at different time points:
- Baseline: before the neo-adjuvant ICB treatment
- At surgery
- During the adjuvant immunotherapy (if applicable):
- before the 3rd ICB administration
- before the 5th ICB administration
- at the time of treatment permanent discontinuation
- at the time of recurrence
- During the follow-up period : twice a year for maximum of 5 year duration since baseline
A fragment of tumor samples will be analyzed as part of the research. They will be collected per SOC at the following timepoints:
- Pre-neoadjuvant treatment (archived sample)
- At surgery
- At progression if a tumor biopsy is clinically indicated
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting | Other | Not described Receives: Other: Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable) |
What is being measured
The primary outcome is the main question the study is designed to answer.
- NSCLC / Head & Neck / Melanoma: Rate of major pathological response - Bladder cancer: rate of complete pathological response - Exploratory: rate of pathological response
- NSCLC / Head \& Neck / Melanoma: Rate of major pathological response = mPR, i.e. ≤10% residual viable tumor cells
- Bladder cancer: rate of complete pathological response = pCR, i.e. absence of residual viable tumor cells
- Exploratory: rate of pathological response (as defined by investigator).
Measured: 5 years per patient
Secondary outcomes (2)
Event-free survival (EFS)
Time from inclusion until disease recurrence or progression according to investigator judgment, or death, whichever occurs first. Patients alive and without recurrence or progression are censored at last follow-up news or at initiation of new anticancer treatment (if applicable).
Measured: 5 years per patient
Overall survival (OS)
Time from inclusion until death from any cause. Patients alive are censored at last follow-up news.
Measured: 5 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start6 Aug 2026
- Primary completion6 Aug 2041 (estimated)
- Study completion6 Aug 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427186
- Sponsor's protocol ID
- 26 GENE 01
- Acronym
- MINER2
- Status last verified
- Aug 2026
- First submitted
- 17 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer
- ClinicalTrials.gov ID
- NCT07427186
- Acronym / sponsor ID
- MINER2 / 26 GENE 01
- Conditions
- Solid Cancers
- Keywords
- Immunotherapy, tumor microenvironment, adaptive immune responses, Immune checkpoint blockade, tumor antigens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 6 Aug 2041 (estimated)
- Study completion
- 6 Aug 2041 (estimated)
- First posted
- 23 Feb 2026 (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.
This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). Patients with any of the following tumor types may be enrolled in the trial:
Non-Small Cell Lung Cancer (NSCLC), Head and neck cancer, Melanoma, Bladder cancer, Other tumor types when Immuno-Oncology agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.
All included patients will be followed up for 5 years after baseline.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting | Other | Other: Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)Blood samples will be collected at different time points: * Baseline: before the neo-adjuvant ICB treatment * At surgery * During the adjuvant immunotherapy (if applicable): * before the 3rd ICB administration * before the 5th ICB administration * at the time of treatment permanent discontinuation * at the time of recurrence * During the follow-up period : twice a year for maximum of 5 year duration since baseline A fragment of tumor samples will be analyzed as part of the research. They will be collected per SOC at the following timepoints: * Pre-neoadjuvant treatment (archived sample) * At surgery * At progression if a tumor biopsy is clinically indicated | Other | Patients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting |
Primary outcome
- NSCLC / Head & Neck / Melanoma: Rate of major pathological response - Bladder cancer: rate of complete pathological response - Exploratory: rate of pathological response
Time frame: 5 years per patient
* NSCLC / Head \& Neck / Melanoma: Rate of major pathological response = mPR, i.e. ≤10% residual viable tumor cells * Bladder cancer: rate of complete pathological response = pCR, i.e. absence of residual viable tumor cells * Exploratory: rate of pathological response (as defined by investigator).
2 secondary outcomes
Event-free survival (EFS)
Time frame: 5 years per patient
Overall survival (OS)
Time frame: 5 years per patient
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 19 Aug 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable) in people with Solid Cancers, run by Institut Claudius Regaud at 3 sites 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 8 inclusion and 7 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Jean-Pierre DELORD, MD, Professor (+33 5 31 15 55 00, delord.jean-pierre@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- NSCLC / Head & Neck / Melanoma: Rate of major pathological response - Bladder cancer: rate of complete pathological response - Exploratory: rate of pathological response (time frame: 5 years per patient). 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 19 Aug 2026.