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

Last updated: April 14, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Renal Cancer

Cancer/tumors

Kidney Cancer

Treatment

N/A

Clinical Study ID

NCT05285579
APHP211213
IDRCB2021-A02030-41
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven advanced or metastatic renal carcinoma
  • treated in first line with an ICI-ICI or ITK-ICI combination (following currentrecommendations at inclusion)

Exclusion

Exclusion Criteria:

  • Previous systemic treatment for renal cell carcinoma
  • Other cancer developed in the last 5 years except local forms apparently healed asbasal 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 toL1121-8) :
  • Major patient subjected to legal protection (guardianship, curatorship, protection ofjustice)
  • Pregnant or breastfeeding woman

Study Design

Total Participants: 100
Study Start date:
May 05, 2022
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Hôpital Cochin - AP-HP

    Paris,
    France

    Active - Recruiting

  • Hôpital européen Georges-Pompidou AP-HP

    Paris, 75015
    France

    Active - Recruiting

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