NCT03628859

Brief Summary

The BIOREN project aims are to characterize the genetic background of renal cell carcinomas and their immune environment, to try and identify biomarkers of response and to better understand the mechanisms of resistance to nivolumab in renal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

4.4 years

First QC Date

March 28, 2018

Last Update Submit

March 14, 2022

Conditions

Renal Cancer Metastatic

Keywords

Renal cancer metastaticImmunotherapyPredictive biomarkersTranslational study

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Tregs function on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment

    Ex vivo effect of CXCR4 antagonists (PCT/IB2011/000120/ EP2528936B1/ US2013/0079292A1) and other Tregs targets antagonists (ICOS, CD39/CD73) or agonists (TLR7L) as putative anti-PD1 resistance mechanisms

    Evolution of percentage of CD4+CD25+ CD127low FOXP3+ cells between inclusion and up to 24 months

Secondary Outcomes (4)

  • Evaluation of NK function/cytotoxicity on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment

    Evolution between inclusion and up to 24 months

  • Exploration of the biological rationale for coupling CXCR4 antagonist with anti-PD-1 in in vivo models of renal cancer (mice models).

    Up to 24 months

  • Identification of response biomarkers

    Up to 24 months

  • Identification of biomarkers of response

    Evolution between inclusion and up to 24 months

Interventions

Immunological and tumour characterizationBIOLOGICAL

FFPE, blood samples (liquid biopsy, heparin and EDTA blood) performed in patients presenting a renal metastatic cancer receiving treatment as standard practice according to physician's choice (2nd or 3rd line of treatment with nivolumab, everolimus, axitinib or cabozantinib \[in France only\], as per product SmPC or 1st line treatment with sunitinib or pazopanib or receiving 2nd or 3rd line of treatment with nivolumab)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients presenting a renal metastatic cancer included in Centre Leon Berard for evaluating the mechanisms involved in resistance to immunotherapy: * Cohort 1: ccRCC patients receiving nivolumab, * Cohort 2: ccRCC patients receiving axitinib or cabozantinib or sunitinib or pazopanib, * Cohort 3: ccRCC patients receiving everolimus.

You may qualify if:

  • Age ≥ 18 years-old.
  • Histology proven locally advanced (unresectable) or metastatic clear cell renal cell carcinoma (mccRCC).
  • Starting 2nd or 3rd line of treatment with nivolumab, everolimus, axitinib or cabozantinib as per summaries of product characteristics (SmPC) or 1st line treatment with sunitinib or pazopanib or receiving 2nd or 3rd line of treatment with nivolumab
  • Signed informed consent.

You may not qualify if:

  • Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archival FFPE specimen Blood samples performed during standard visits and not requiring additional blood tests: * Heparin blood (4 x 6ml) * EDTA blood (5 x 6ml) * Liquid biopsy (EDTA) (5 x 6ml)

Study Officials

  • BOYLE J Helen, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BLANC Ellen

CONTACT

+33 4.78.78.29.67ellen.blanc@lyon.unicancer.fr

BOYLE J Helen, MD

CONTACT

+33 4.26.55.67.52helen.boyle@lyon.unicancer.fr

Study Design

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

Study Record Dates

First Submitted

March 28, 2018

First Posted

August 14, 2018

Study Start

December 21, 2018

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2022

Record last verified: 2022-03

Locations

FR(1)