Renal Cancer, Renal Cancer Metastatic, Renal Cell Carcinoma
Conditions
Keywords
renal cell carcinoma, blood biomarkers, predictive factor, tyrosine kinase inhibitor, immune checkpoint inhibitor
Brief summary
This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.
Detailed description
Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.
Interventions
BIOLOGICALBlood collection
Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer
OTHERTumour samples
reuse of tumour tissue collect in usual patient care
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
FONCER contre le cancer
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 24 months | Time from inclusion to progression documented by imaging and based on RECIST 1.1 and iRECIST criteria or patient death. The iRECIST criteria use the same methods of monitoring tumor lesions as the RECIST 1.1 criteria but a confirmation 4-6 weeks after suspicion of progression is required to confirm or rule out progression because patients undergoing immunotherapy may present pseudo-progressions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 24 months | Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up |
| Response duration | 24 months | Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression |
Countries
France
Contacts
Primary ContactNatacha Nohilé
Backup ContactLaetitia MAUGE, PharmD, PhD
Outcome results
None listed