Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer

ConditionSolid Cancers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud

About this trial

This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). 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 in a neo-adjuvant setting (whether in standard of care or within a clinical trial).

For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.

All included patients will be followed up for 5 years after baseline.

Eligibility criteria

Qualifiers

Age ≥18 years at the time of study entry.

Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).

Patient for whom a neo-adjuvant 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 with chemotherapy or other therapies has been decided.

Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable)

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators