Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer (MINER2)

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 Overview

• Status: Not yet recruiting
• Conditions: Solid Cancers
• Intervention / Treatment: Other: Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Pierre DELORD, MD, Professor; Phone Number: +33 5 31 15 55 00; Email: delord.jean-pierre@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer de Toulouse - Oncopole
    • Contact: Jean-Pierre DELORD, MD, Professor; Phone Number: 05 31 15 55 00; Email: delord.jean-pierre@iuct-oncopole.fr
  • Toulouse, France, 31400
    • CHU Rangueil
    • Contact: Nadim FARES, MD; Phone Number: 05 61 32 21 42; Email: fares.n@chu-toulouse.fr
  • Toulouse, France, 31400
    • Hôpital Larrey
    • Contact: Julien MAZIERES, MD; Phone Number: 05 67 77 18 37; Email: mazieres.j@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  1. Age ≥18 years at the time of study entry.
  2. 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).
  3. 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.
  4. Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.
  5. Treatment with ICB not yet started.
  6. ECOG Performance status 0-2.
  7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
  8. Patient affiliated to a Social Health Insurance in France.

• Exclusion Criteria:

  1. Patient pregnant, or breast-feeding.
  2. Uveal melanoma
  3. Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
  4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
  6. 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.
  7. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting

Other: 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 administrationbefore the 5th ICB administrationat 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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).	5 years per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 years per patient
Overall survival (OS)	Time from inclusion until death from any cause. Patients alive are censored at last follow-up news.	5 years per patient

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2041
• Study Completion (Estimated): April 15, 2041

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Immune checkpoint blockade; tumor microenvironment; tumor antigens; adaptive immune responses
• Additional Relevant MeSH Terms: Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Immune Checkpoint Inhibitors
• Other Study ID Numbers: 26 GENE 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No