Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03514368

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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