Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer … (NCT03514368) | Clinical Trial Compass
RecruitingNot Applicable
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
France770 participantsStarted 2018-05-28
Plain-language summary
This is a translational, open-label, multi-site, prospective cohort study 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of objective response (complete or partial response)
. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
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.