Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT03514368
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2018-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Sponsor:
Institut Claudius Regaud
Organization:
Study Overview
Official Title:
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MINER
Brief Summary:
This trial is a translational, open-label, multi-site, prospective cohort study of 520 patients 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: