Identifying biomarkers for kidney cancer treatment response
Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic
This study is trying to find specific markers in blood and tumor samples that can help predict how well patients with advanced kidney cancer will respond to a combination of immunotherapy and other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05285579 on ClinicalTrials.gov |
What this trial studies
This multicenter, exploratory study aims to identify angiogenesis and immune-related biomarkers that can predict progression-free survival in patients with advanced or metastatic renal cell carcinoma. The study focuses on patients receiving a combination of immunotherapy and antiangiogenic treatments, specifically tyrosine kinase inhibitors and immune checkpoint inhibitors. By analyzing blood and tumor samples, researchers hope to uncover new biomarkers that could guide treatment decisions and improve patient outcomes. The study is open-label and prospective, involving multiple centers to gather diverse data.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically proven advanced or metastatic renal carcinoma who are starting first-line treatment with a combination of immune checkpoint inhibitors and tyrosine kinase inhibitors.
Not a fit: Patients who have previously received systemic treatment for renal cell carcinoma or have other cancers within the last five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with advanced kidney cancer, improving their chances of survival.
How similar studies have performed: Other studies have explored biomarkers in cancer treatment, but this specific approach focusing on the combination of TKI and ICI in renal cell carcinoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically proven advanced or metastatic renal carcinoma * treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion) Exclusion Criteria: * Previous systemic treatment for renal cell carcinoma * Other cancer developed in the last 5 years except local forms apparently healed as basal cell cancer. * Contraindication for ICI-ICI or TKI-ICI combinations recommended on 1st line * Refusal to participate in the study * No affiliation to a social security regime (beneficiary or entitled) * Vulnerable patients as defined by french law (Public Heath Code sections L1121 -5 to L1121-8) : * Major patient subjected to legal protection (guardianship, curatorship, protection of justice) * Pregnant or breastfeeding woman
Where this trial is running
Paris and 1 other locations
- Hôpital européen Georges-Pompidou AP-HP — Paris, France (Recruiting)
- Hôpital Cochin - AP-HP — Paris, France (Recruiting)
Study contacts
- Principal investigator: Laetitia MAUGE, PharmD, PhD — Assitance Puplique - Hôpitaux de Paris
- Study coordinator: Natacha Nohilé
- Email: natacha.nohile@aphp.fr
- Phone: 33156095982
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.