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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05285579
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France (Other), FONCER contre le cancer (Other)
• Enrollment: 100
• Locations: 2
• Anticipated Duration (Months): 39
• Patients Per Site: 50
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma; Renal Cancer; Renal Cancer Metastatic	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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Objective response rate [24 months]

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

2. Response duration [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital européen Georges-Pompidou AP-HP	Paris		France	75015
2	Hôpital Cochin - AP-HP	Paris		France

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT05285579
• Other Study ID Numbers: APHP211213; IDRCB2021-A02030-41
• First Posted: Mar 17, 2022
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: renal cell carcinoma; blood biomarkers; predictive factor; tyrosine kinase inhibitor; immune checkpoint inhibitor
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms

Study Results

No Results Posted as of Mar 17, 2022