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

Recruiting

• Conditions: Renal Cell Carcinoma; Renal Cancer Metastatic; Renal Cancer
• Interventions: Biological: Blood collection; Other: Tumour samples

• Registration Number: NCT05285579
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Study Start: 2022-05-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICI+ICI	Blood collection	Therapeutic combination with different immune checkpoint inhibitors (ICI)
ICI+ICI	Tumour samples	Therapeutic combination with different immune checkpoint inhibitors (ICI)
TKI+ICI	Tumour samples	Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)
TKI+ICI	Blood collection	Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)

Primary Outcome Measures

Name	Time	Method
Progression-free survival	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Objective response rate	24 months	Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up
Response duration	24 months	Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression

Trial Locations

Locations (2)

Hôpital Cochin - AP-HP; 🇫🇷 Paris, France

Hôpital européen Georges-Pompidou AP-HP; 🇫🇷 Paris, France