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

Renal Cell Carcinoma Clinical Trial

— ANGIOCOR  

Official title:

Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285579
• Other study ID #: APHP211213
• Secondary ID: IDRCB2021-A02030
• Status: Recruiting
• Start date: May 5, 2022
• Est. completion date: August 2025

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natacha Nohilé
• Phone: 33156095982
• Email: natacha.nohile[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer
• Renal Cancer Metastatic
• Renal Cell Carcinoma

Intervention

Biological:
• Blood collection
Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

Other:
• Tumour samples
reuse of tumour tissue collect in usual patient care

Locations

Country	Name	City	State
France	Hôpital Cochin - AP-HP	Paris
France	Hôpital européen Georges-Pompidou AP-HP	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	FONCER contre le cancer, Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	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.	24 months
Secondary	Objective response rate	Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up	24 months
Secondary	Response duration	Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression	24 months