Identifying Predictive Markers for Immune-related Side Effects in Cancer Treatment
Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
This study is trying to find signs in the blood that can help predict serious side effects from cancer treatments that boost the immune system, so doctors can help patients more quickly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 5 sites (Villejuif, Val De Marne and 4 other locations) |
| Trial ID | NCT03984318 on ClinicalTrials.gov |
What this trial studies
This study aims to identify predictive markers for immune-related adverse events (IrAE) in patients undergoing treatment with immune stimulatory drugs, particularly monoclonal antibodies targeting immune checkpoints. By analyzing blood samples from patients with various types of cancer, the study seeks to understand the underlying mechanisms that lead to these unpredictable and potentially severe side effects. The goal is to improve patient care by enabling timely intervention for IrAE, which can significantly impact treatment outcomes. Participants will include adults with both liquid and solid tumors receiving immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with either liquid or solid malignancies currently receiving immunotherapy involving immune checkpoint inhibitors.
Not a fit: Patients who are not receiving immunotherapy or those with conditions unrelated to cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of immune-related adverse events, enhancing the safety and efficacy of immunotherapy for cancer patients.
How similar studies have performed: While the study addresses a critical area of immunotherapy, similar approaches have shown promise in identifying adverse effects, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Patients with either liquid (hematological) or solid malignancy, in any line of treatment. * Patients treated with an immunotherapy based on immune checkpoint targeted monoclonal antibody (mainly anti-PD-1, anti-PD-L1, anti-CTLA-4 monotherapies and combinations) * Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. * Patients must be affiliated to a social security system or beneficiary of the same * Patient able to read and write French * Women of child bearing potential must have a negative serum or urine β-HCG pregnancy test within 14 days prior to initiation of treatment * Sexually active women of childbearing potential must agree to use a highly effective method of birth control supplemented by a barrier method during the trial and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy * Sexually active males patients must agree to use condom during the study and for the duration planned in the SmPC or the study protocol after the last administration of each immunotherapy. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception Exclusion Criteria: * Patients treated with immunotherapies that do not contain at least one immunomodulatory drug targeted against a co inhibitory checkpoint molecule * Known severe hypersensitivity reactions to monoclonal antibodies * Pregnant or breastfeeding women * Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Where this trial is running
Villejuif, Val De Marne and 4 other locations
- Gustave Roussy — Villejuif, Val De Marne, France (Recruiting)
- Gustave Roussy — Chevilly-Larue, France (Recruiting)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (Not_yet_recruiting)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (Not_yet_recruiting)
- Hôpital Paul Brousse — Villejuif, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Aurélien Marabelle, MD
- Email: aurelien.marabelle@gustaveroussy.fr
- Phone: +33 (0)1 42 11 42 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.