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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Renal Cancer Metastatic
Renal Cancer
Renal Cell Carcinoma

Treatments

Biological: Blood collection
Other: Tumour samples

Study type

Observational

Funder types

Other

Identifiers

NCT05285579
APHP211213
IDRCB2021-A02030-41 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

TKI+ICI
Description:
Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)
Treatment:
Biological: Blood collection
Other: Tumour samples
ICI+ICI
Description:
Therapeutic combination with different immune checkpoint inhibitors (ICI)
Treatment:
Biological: Blood collection
Other: Tumour samples

Trial contacts and locations

2

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Central trial contact

Laetitia MAUGE, PharmD, PhD; Natacha Nohilé

Data sourced from clinicaltrials.gov

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