Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-05

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Cell Carcinoma Renal Cancer Renal Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TKI+ICI

Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)

Blood collection

Intervention Type BIOLOGICAL

Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

Tumour samples

Intervention Type OTHER

reuse of tumour tissue collect in usual patient care

ICI+ICI

Therapeutic combination with different immune checkpoint inhibitors (ICI)

Blood collection

Intervention Type BIOLOGICAL

Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

Tumour samples

Intervention Type OTHER

reuse of tumour tissue collect in usual patient care

Interventions

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Blood collection

Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

Intervention Type BIOLOGICAL

Tumour samples

reuse of tumour tissue collect in usual patient care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No