Analyzing Resistance and Toxicity in Cancer Treatments
POSITive: Prospective Observational Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies
This study is trying to understand why some cancer treatments don't work for everyone and what side effects they cause, so that doctors can better tailor treatments for patients with different types of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 265 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | tocilizumab, prednisone |
| Locations | 1 site (Milan) |
| Trial ID | NCT06321640 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the resistance mechanisms and toxicities associated with targeted therapies and immune checkpoint inhibitors in various cancers, including breast cancer, lung cancer, melanoma, head and neck cancer, and urothelial carcinoma. It aims to identify biomarkers that can predict patient responses and adverse effects to these treatments, which are crucial for optimizing therapeutic strategies. The study involves multiple cohorts based on disease stage, from operable to metastatic conditions, and requires participants to undergo diagnostic biopsies. By exploring the molecular mechanisms of resistance and toxicity, the study seeks to improve treatment outcomes for cancer patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a histological diagnosis of any cancer who meet specific cohort criteria.
Not a fit: Patients with a performance status greater than 2 or a life expectancy of less than 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective cancer treatments by identifying which therapies are best suited for individual patients based on their unique biomarkers.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for targeted therapies, but this study's comprehensive approach to resistance and toxicity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age\>18 yrs old * histological diagnosis of any cancer * signed informed consent * fulfills criteria described in cohort definition * Clinical indication for a diagnostic biopsy Exclusion Criteria: Performance Status (ECOG) \>2 * life expectancy \< 3 months * unwilling to receive treatment at IEO for at least 6 months after enrolment * active pregnancy at the moment of enrolment * for cohort F: use of steroids (higher than 10 mg prednisone-equivalent) or other major immunosuppressive drug (e.g. tocilizumab) in the 14 days prior to the baseline sample collection.
Where this trial is running
Milan
- European Institute of oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Mazzarella — European Institute of Oncology
- Study coordinator: Luca Mazzarella
- Email: luca.mazzarella@ieo.it
- Phone: +390294375111
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.