Renal Cell CarcinomaANGIOCORNCT05285579
Biomarkers of Angiogenesis for Response to Therapeutic Combination in Advanced or Metastatic Kidney Cancer
An observational study of Renal Cell Carcinoma and Renal Cancer, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Renal Cancer, Renal Cancer Metastatic
- What is being tested?
- Blood collection and Tumour samples
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2022to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Histologically proven advanced or metastatic renal carcinoma
- treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital européen Georges-Pompidou AP-HP
Paris, 75015
Marie AUVRAY-KUNITZ, MD
Marie AUVRAY-KUNITZ, MD
- Recruiting
Hôpital Cochin - AP-HP
Paris
Olivier HUILLARD, MD
Olivier HUILLARD, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Cell Carcinoma, Renal Cancer, Renal Cancer Metastatic
- Being tested
- Blood collection, Tumour samples
- Keywords
- renal cell carcinoma, blood biomarkers, predictive factor, tyrosine kinase inhibitor, immune checkpoint inhibitor
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| TKI+ICI | Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI) Receives: Biological: Blood collection; Other: Tumour samples | |
| ICI+ICI | Therapeutic combination with different immune checkpoint inhibitors (ICI) Receives: Biological: Blood collection; Other: Tumour samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
Objective response rate
Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up
Measured: 24 months
Response duration
Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start5 May 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, FONCER contre le cancer
- Responsible party
- Sponsor
- Investigators
- Laetitia MAUGE, PharmD, PhD, Principal investigator, Assitance Puplique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285579
- Sponsor's protocol ID
- APHP211213
- Other IDs
- IDRCB2021-A02030-41
- Acronym
- ANGIOCOR
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Circulating Biomarkers Involved in Angiogenesis in Metastatic Kidney Cancer in the Era of New Therapeutic Associations: Immunotherapies, Anti-angiogenic
- ClinicalTrials.gov ID
- NCT05285579
- Acronym / sponsor ID
- ANGIOCOR / APHP211213
- Conditions
- Renal Cell Carcinoma, Renal Cancer, Renal Cancer Metastatic
- Keywords
- renal cell carcinoma, blood biomarkers, predictive factor, tyrosine kinase inhibitor, immune checkpoint inhibitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, FONCER contre le cancer
- Study start
- 5 May 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKI+ICI | – | Biological: Blood collection, Other: Tumour samplesTherapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI) |
| ICI+ICI | – | Biological: Blood collection, Other: Tumour samplesTherapeutic combination with different immune checkpoint inhibitors (ICI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Histologically proven advanced or metastatic renal carcinoma
- treated in first line with an ICI-ICI or ITK-ICI combination (following current recommendations at inclusion)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionSystematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer | Biological | ICI+ICI, TKI+ICI |
| Tumour samplesreuse of tumour tissue collect in usual patient care | Other | ICI+ICI, TKI+ICI |
Primary outcome
Progression-free survival
Time frame: 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.
2 secondary outcomes
Objective response rate
Time frame: 24 months
Response duration
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laetitia MAUGE, PharmD, PhD principal investigator
Assitance Puplique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma and Renal Cancer, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natacha Nohilé (33156095982, natacha.nohile@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.