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Clinical Trial NCT07427186 (MINER2) for Solid Cancers is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer (MINER2) 600 Immunotherapy Biomarker-Driven Translation Available

Not yet recruiting
Clinical Trial NCT07427186 (MINER2) is an interventional study for Solid Cancers and is currently not yet recruiting. Enrollment is planned to begin on 15 April 2026 and continue until the study accrues 600 participants. Led by Institut Claudius Regaud, this study is expected to complete by 15 April 2041. The latest data from ClinicalTrials.gov was last updated on 25 February 2026.
Brief 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 early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and a...Show More
Official Title

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

Conditions
Solid Cancers
Other Study IDs
  • MINER2
  • 26 GENE 01
NCT ID Number
NCT07427186
Start Date (Actual)
2026-04-15
Last Update Posted
2026-02-25
Completion Date (Estimated)
2041-04-15
Enrollment (Estimated)
600
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Immunotherapy
tumor microenvironment
adaptive immune responses
Immune checkpoint blockade
tumor antigens
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherPatients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting
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 bas...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Institut Claudius Regaud logoInstitut Claudius Regaud
Study Central Contact
Contact: Jean-Pierre DELORD, MD, Professor, +33 5 31 15 55 00, [email protected]
3 Study Locations in 1 Countries
Institut Universitaire Du Cancer de Toulouse - Oncopole, Toulouse, 31059, France
Jean-Pierre DELORD, MD, Professor, Contact, 05 31 15 55 00, [email protected]
Chu Rangueil, Toulouse, 31400, France
Nadim FARES, MD, Contact, 05 61 32 21 42, [email protected]
Hopital Larrey, Toulouse, 31400, France
Julien MAZIERES, MD, Contact, 05 67 77 18 37, [email protected]