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

Assistance Publique - Hôpitaux de Paris100 enrolled

Overview

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.

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

100

Conditions

Renal Cell Carcinoma Renal Cancer Renal Cancer Metastatic

Interventions

Blood collectionBIOLOGICAL

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

Tumour samplesOTHER

reuse of tumour tissue collect in usual patient care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hôpital européen Georges-Pompidou AP-HP

Paris, France

RECRUITING

Hôpital Cochin - AP-HP

Paris, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Objective response rate

Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up

Time frame: 24 months

Response duration

Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression

Time frame: 24 months

Central Contacts

Natacha Nohilé

CONTACT

33156095982 natacha.nohile@aphp.fr

Laetitia MAUGE, PharmD, PhD

CONTACT

33156093905 laetitia.mauge@aphp.fr

Data from ClinicalTrials.gov

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