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

NCT05285579 | Unknown

• 2 other identifiers: APHP211213IDRCB2021-A02030-41
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Cell Carcinoma; Renal Cancer; Renal Cancer Metastatic

Keywords

renal cell carcinoma; blood biomarkers; predictive factor; tyrosine kinase inhibitor; immune checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Objective response rate

  24 months

• Response duration

  24 months

Study Arms (2)

TKI+ICI

Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI)

Biological: Blood collection; Other: Tumour samples

ICI+ICI

Therapeutic combination with different immune checkpoint inhibitors (ICI)

Biological: Blood collection; Other: Tumour samples

Interventions

Blood collection BIOLOGICAL

Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer

ICI+ICI; TKI+ICI

Tumour samples OTHER

reuse of tumour tissue collect in usual patient care

ICI+ICI; TKI+ICI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Histologically proven advanced or metastatic renal carcinoma

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• FONCER contre le cancer: collaborator

Study Sites (2)

Hôpital européen Georges-Pompidou AP-HP

Paris, 75015, France

RECRUITING

Hôpital Cochin - AP-HP

Paris, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma + tumour tissue

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laetitia MAUGE, PharmD, PhD

  Assitance Puplique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natacha Nohilé

CONTACT

33156095982; natacha.nohile@aphp.fr

Laetitia MAUGE, PharmD, PhD

CONTACT

33156093905; laetitia.mauge@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: May 5, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• 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).

Locations

FR (2)