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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the immune system responds to immune checkpoint blockade (ICB) treatments in patients with advanced solid cancers that cannot be removed by surgery or have spread to other parts of the body. This open-label, multi-site study aims to find and monitor immune markers linked to how well patients respond to treatments like anti-PD-1, anti-PD-L1, or anti-CTLA4, either alone or combined. Participants may have cancers such as non-small cell lung cancer, head and neck cancer, melanoma, bladder cancer, or other tumors where immunotherapy is expected to work or clinical trials are an option. Participants will receive immune checkpoint blockade treatments as part of standard care or other clinical trials. The study involves collecting tumor biopsy samples and blood at different times: before treatment starts, before the third and fifth ICB doses (blood only), when treatment stops (blood only), at progression (tumor biopsy only), and after the last treatment dose with blood samples twice per year until the study ends. This helps researchers track immune responses over time. During the study, patients will be followed until their disease progresses. Researchers will gather survival information afterward. They will assess treatment response rates, progression-free survival, immune-related side effects, and anti-tumor immune reactions. Patients will provide informed consent, and their health will be monitored regularly through these biological samples and clinical evaluations to understand treatment effects and safety over about 18 months or longer.
CONDITIONS
Brief 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 and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma except uveal melanoma, bladder cancer, or other advanced solid tumors where immunotherapy is expected to work or clinical trial is an option)
- Treatment with immune checkpoint blockade (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies alone or in combination) has been decided
- Archived tumor specimen available or able to undergo pre-treatment tumor biopsy
- Current treatment with immune checkpoint blockade has not yet started
- Disease is evaluable, measurable or not, as per RECIST 1.1
- ECOG Performance status between 0 and 2
- Able and willing to provide informed consent before any study procedures
- Affiliated with Social Health Insurance in France
You will not qualify if you...
- Pregnant or breastfeeding
- Diagnosis of uveal melanoma
- Any condition preventing required tumor or blood sampling procedures
- Known positive test history for hepatitis B, hepatitis C, HIV, or AIDS
- Any severe or uncontrolled disease including active infection or autoimmune disorders
- Psychological, familial, geographic, or social situations preventing informed consent or study compliance
- Under legal guardianship or deprived of freedom by administrative or legal decision
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of treatment until permanent discontinuation or progression
Participants receive immune checkpoint blockade therapy with blood and tumor samples collected at multiple time points during treatment.
Blood samples at baseline, before 3rd and 5th therapy administrations, at treatment discontinuation, and twice per year after last dose; tumor biopsies at baseline and at progression
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
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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