Solid CancersMINERNCT03514368
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
A study testing Patients treated with immune checkpoint blockade in people with Solid Cancers, run by Institut Claudius Regaud at 3 sites in France.
Trial summary
This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 3 sitesFrance
- Study dates
- 28 May 2018to Nov 2029
- 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 metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
- Patient for which a 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 has been decided.
- Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
- Current treatment with ICB not yet started.
- Evaluable disease (measurable as per RECIST 1.1. or not).
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- 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
Hopital Larrey
Toulouse, 31059
Julien MAZIERES, MD, 05 67 77 18 37, mazieres.j@chu-toulouse.fr
- Recruiting
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
Jean-Pierre DELORD, MD, 05 31 15 55 00, delord.jean-pierre@iuct-oncopole.fr
- Recruiting
Chu Rangueil
Toulouse
Nadim FARES, MD, 05 61 32 21 42, fares.n@chu-toulouse.fr
About this study
This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.
The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.
Read more
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 or when a clinical trial is an option.
For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.
All included patients will be followed-up until progression. After this date, survival data will be collected.
- Conditions
- Solid Cancers
- Being tested
- Patients treated with immune checkpoint blockade
- Keywords
- Immune checkpoint modulation, Tumor antigens, Adaptive immune responses, Tumor molecular signature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients treated with immune checkpoint blockadeOther
Tumor biopsy specimens and blood samples will be collected at different time points:
- Baseline
- before the 3rd ICB administration (blood samples only)
- before the 5th ICB administration (blood samples only)
- at the time of treatment permanent discontinuation (blood samples only)
- at the time of progression (tumor biopsy specimens only)
- after the last dose of ICB treatment (blood samples only taken twice per year until study termination)
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with immune checkpoint blockade | Other | Not described Receives: Other: Patients treated with immune checkpoint blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of objective response (complete or partial response)
Response will be assessed according to RECIST 1.1 / investigator judgment
Measured: 18 months by patient
Secondary outcomes (3)
Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Measured: 18 months by patient
Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria
Measured: 18 months by patient
Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Measured: 12 months by patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start28 May 2018
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (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
- 770 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
- NCT03514368
- Sponsor's protocol ID
- 17 GENE 23
- Acronym
- MINER
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2018
- Last updated
- 16 Jun 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT03514368
- Acronym / sponsor ID
- MINER / 17 GENE 23
- Conditions
- Solid Cancers
- Keywords
- Immune checkpoint modulation, Tumor antigens, Adaptive immune responses, Tumor molecular signature
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 2 May 2018 (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, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.
The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.
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 or when a clinical trial is an option.
For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.
All included patients will be followed-up until progression. After this date, survival data will be collected.
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 | Other | Other: Patients treated with immune checkpoint blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at the time of study entry.
- Patient with histologically documented metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
- Patient for which a 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 has been decided.
- Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
- Current treatment with ICB not yet started.
Key exclusion criteria (7 listed)
- 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.
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 blockadeTumor biopsy specimens and blood samples will be collected at different time points: * Baseline * before the 3rd ICB administration (blood samples only) * before the 5th ICB administration (blood samples only) * at the time of treatment permanent discontinuation (blood samples only) * at the time of progression (tumor biopsy specimens only) * after the last dose of ICB treatment (blood samples only taken twice per year until study termination) | Other | Patients treated with immune checkpoint blockade |
Primary outcome
Rate of objective response (complete or partial response)
Time frame: 18 months by patient
Response will be assessed according to RECIST 1.1 / investigator judgment
3 secondary outcomes
Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Time frame: 18 months by patient
Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria
Time frame: 18 months by patient
Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
Time frame: 12 months by 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 16 Jun 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 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 9 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 16 Jun 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 (05 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?
Rate of objective response (complete or partial response) (time frame: 18 months by 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 16 Jun 2026.