Clinical trial NCT03514368: Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Official title: Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Cancers
Keywords: Immune checkpoint modulation
Tumor antigens
Adaptive immune responses
Tumor molecular signature
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. 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).
3. 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.
4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
5. Current treatment with ICB not yet started.
6. Evaluable disease (measurable as per RECIST 1.1. or not).
7. ECOG Performance status 0-2.
8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
9. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

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.

Primary outcomes:
measure: Rate of objective response (complete or partial response)
timeFrame: 18 months by patient
Secondary outcomes:
measure: Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
timeFrame: 18 months by patient
measure: Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria
timeFrame: 18 months by patient
measure: Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
timeFrame: 12 months by patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital Larrey
city: Toulouse
country: France
facility: Institut Universitaire Du Cancer de Toulouse - Oncopole
city: Toulouse
country: France
facility: Chu Rangueil
Study officials:
References: