Actively Recruiting
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Led by Institut Claudius Regaud · Updated on 2026-02-19
770
Participants Needed
3
Research Sites
596 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of study entry
- Histologically confirmed metastatic or unresectable solid tumor including NSCLC, head and neck cancer, melanoma (excluding uveal melanoma), bladder cancer, or other advanced solid tumors where immunotherapy is expected to be effective or clinical trials are available
- Planned treatment with immune checkpoint blockade therapy such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies alone or in combination
- Availability of archived tumor specimen or feasibility of pre-treatment tumor biopsy
- No prior immune checkpoint blockade treatment started
- Disease is evaluable, measurable or not per RECIST 1.1 criteria
- ECOG performance status between 0 and 2
- Able and willing to provide informed consent before any study procedures
- Affiliated with a Social Health Insurance in France
You will not qualify if you...
- Pregnant or breastfeeding patients
- Diagnosis of uveal melanoma
- Any condition preventing tumor or blood sampling as required by the study
- Known positive test history for hepatitis B, hepatitis C, HIV, or AIDS
- Any current severe or uncontrolled illness including active infections or autoimmune disorders
- Psychological, social, or geographic conditions that prevent informed consent or study compliance
- Patients under legal guardianship or deprived of freedom by legal or administrative decisions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Hopital Larrey
Toulouse, France, 31059
Actively Recruiting
2
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, France, 31059
Actively Recruiting
3
Chu Rangueil
Toulouse, France
Actively Recruiting
Research Team
J
Jean-Pierre DELORD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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