Monitoring immune responses and biomarkers in cancer immunotherapy

Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

This study is testing how well certain immune responses and markers in the blood can help predict how patients with advanced solid cancers respond to new immunotherapy treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 770 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Claudius Regaud (Academic / other)
• Locations: 3 sites (Toulouse and 2 other locations)
• Trial ID: NCT03514368 on ClinicalTrials.gov

What this trial studies

This trial is a multi-site, prospective cohort study involving 520 patients with advanced solid cancers who are receiving immune checkpoint blockade therapy. The aim is to identify and monitor immunological biomarkers that correlate with therapeutic responses and potential toxicities associated with treatments like anti-PD-1, anti-PD-L1, and anti-CTLA-4. Patients will have tumor biopsies and blood samples collected at various time points, and they will be followed until disease progression. The study focuses on several types of cancers, including non-small cell lung cancer, melanoma, and bladder cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable or metastatic solid tumors who are about to start treatment with immune checkpoint blockade.

Not a fit: Patients who are pregnant or breastfeeding will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding of how to predict and enhance responses to cancer immunotherapy.

How similar studies have performed: Other studies have shown promise in identifying biomarkers for immunotherapy responses, making this approach both relevant and potentially impactful.

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.

Where this trial is running

Toulouse and 2 other locations

• Hopital Larrey — Toulouse, France (Recruiting)
• Institut Universitaire Du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
• Chu Rangueil — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: Jean-Pierre DELORD, MD

Conditions Solid Cancers; Immune checkpoint modulation; Tumor antigens; Adaptive immune responses; Tumor molecular signature