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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Cell Carcinoma; Renal Cancer; Renal Cancer Metastatic
• Intervention / Treatment: Biological: Blood collection; Other: Tumour samples

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Natacha Nohilé; Phone Number: 33156095982; Email: natacha.nohile@aphp.fr
• Study Contact Backup: Name: Laetitia MAUGE, PharmD, PhD; Phone Number: 33156093905; Email: laetitia.mauge@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hôpital européen Georges-Pompidou AP-HP
    • Contact: Marie AUVRAY-KUNITZ, MD
    • Principal Investigator: Marie AUVRAY-KUNITZ, MD
  • Paris, France
    • Recruiting
    • Hôpital Cochin - AP-HP
    • Contact: Olivier HUILLARD, MD
    • Principal Investigator: Olivier HUILLARD, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a metastatic or advanced renal cell carcinoma who will benefit of an ICI-TKI or ICI-ICI combination as a first-line treatment (according to the current guidelines at the time of inclusion).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TKI+ICI; Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)	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
ICI+ICI; Therapeutic combination with different immune checkpoint inhibitors (ICI)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; FONCER contre le cancer
• Investigators: Principal Investigator: Laetitia MAUGE, PharmD, PhD, Assitance Puplique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; blood biomarkers; renal cell carcinoma; predictive factor; immune checkpoint inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: APHP211213; IDRCB2021-A02030-41 (Registry Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
• IPD Sharing Time Frame: Two years after the last publication
• IPD Sharing Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No