Clinical trial NCT05285579: Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer
Official title: Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Cell Carcinoma
Renal Cancer
Renal Cancer Metastatic
Keywords: renal cell carcinoma
blood biomarkers
predictive factor
tyrosine kinase inhibitor
immune checkpoint inhibitor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: FONCER contre le cancer
First posted: 2022-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a metastatic or advanced renal cell carcinoma who will benefit of an ICI-TKI or ICI-ICI combination as a first-line treatment (according to the current guidelines at the time of inclusion).

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.

Eligibility 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Objective response rate
timeFrame: 24 months
measure: Response duration
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou AP-HP
city: Paris
country: France
facility: Hôpital Cochin - AP-HP
Study officials:
affiliation: Assitance Puplique - Hôpitaux de Paris
name: Laetitia MAUGE, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: