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NCT Number: NCT07427186

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer

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.

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Key information

Conditions

Solid Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rangueil, Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion Criteria:

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.
Exclusion Criteria:

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.

Treatment and study plan

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

Primary outcomes

- 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).

Secondary outcomes

Event-free survival (EFS)

Time frame: 5 years per patient

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).
Overall survival (OS)

Time frame: 5 years per patient

Time from inclusion until death from any cause. Patients alive are censored at last follow-up news.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Pierre DELORD, MD, Professor

CONTACT

[email protected]

+33 5 31 15 55 00

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MINER2

Important dates

Study start: 2026
Primary completion: 2041
Study completion: 2041
First posted: Feb 23, 2026
Registry last updated: Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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