- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514368
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy (MINER)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Pierre DELORD, MD
- Phone Number: 05 31 15 55 00
- Email: delord.jean-pierre@iuct-oncopole.fr
Study Locations
-
-
-
Toulouse, France, 31059
- Recruiting
- Institut Universitaire du Cancer de Toulouse - Oncopole
-
Contact:
- Jean-Pierre DELORD, MD
- Phone Number: 05 31 15 55 00
- Email: delord.jean-pierre@iuct-oncopole.fr
-
Toulouse, France, 31059
- Recruiting
- Hopital Larrey
-
Contact:
- Julien MAZIERES, MD
- Phone Number: 05 67 77 18 37
- Email: mazieres.j@chu-toulouse.fr
-
Toulouse, France
- Recruiting
- CHU Rangueil
-
Contact:
- Nadim FARES, MD
- Phone Number: 05 61 32 21 42
- Email: fares.n@chu-toulouse.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients treated with immune checkpoint blockade
|
Tumor biopsy specimens and blood samples will be collected at different time points:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 months by patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
18 months by patient
|
Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria
Time Frame: 18 months by patient
|
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
|
12 months by patient
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17 GENE 23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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