Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy (MINER)
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|ClinicalTrials.gov Identifier: NCT03514368|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : August 8, 2019
This trial is a translational, open-label, multi-site, prospective cohort study of 440 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,
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Cancers||Other: Patients treated with immune checkpoint blockade||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy|
|Actual Study Start Date :||May 28, 2018|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
|Patients treated with immune checkpoint blockade||
Other: Patients treated with immune checkpoint blockade
Tumor biopsy specimens and blood samples will be collected at different time points:
- 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
- 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 ]
- Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria [ Time Frame: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514368
|Contact: Jean-Pierre DELORD, MD||05 31 15 55 email@example.com|
|Toulouse, France, 31059|
|Contact: Julien MAZIERES, MD 05 67 77 18 37 firstname.lastname@example.org|
|Institut Universitaire Du Cancer de Toulouse - Oncopole||Recruiting|
|Toulouse, France, 31059|
|Contact: Jean-Pierre DELORD, MD 05 31 15 55 00 email@example.com|