Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT05219318
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at time of signing informed consent form
* Signed informed consent form
* Histological confirmation of RCC with a Clear-cell component, including subject who also have a sarcomatoïd feature
* Advanced (not amenable to curative surgery or radiation therapy) or Metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
* Participants with good or intermediate risk with only one adverse prognostic factor will be eligible as per International Metastatic RCC Database Consortium (IMDC) criteria
* Prior first line therapy for mRCC with the combination of PD-1/ PD-L1 ICI plus VEGFR-TKI
* First line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI must be ongoing whatever the dose with no period of discontinuation \> 6 consecutive weeks during treatment of the PD-1/PD-L1 ICI, and 2 consecutive weeks in the last 3 months before randomisation for the VEGFR-TKI
* Patients with an objective response (complete response or partial response) between the end of 11th month and the end of the 13th month of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI. CT scan at the initiation of this treatment must be available.
* Karnofsky Performance Status (KPS) grade ≥ 70%
* Measurable disease as per RECIST v1.1 per investigator on CT scan at the initiation of first line treatment with combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI
* Adequate organ function
* Females of childbearing potential must use a highly effective contraception (combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral ; intravaginal ;transdermal) ; progestogen-only hormonal contraception associated with inhibition of ovulation (oral ; injectable ; implantable ; intrauterine device (IUD) ; intrauterine hormone-releasing system ( IUS)) ; bilateral tubal occlusion ; vasectomised partner ; sexual abstinence) and continue its use for 5 months after the last PD1/PD L1 ICI administration.
* Sexually active male patients must agree to use condoms and continue its use for 5 months after the last PD1/PD L1 ICI administration.
* Willingness and ability to comply with study procedures.
* Patient affiliated to a social security system or benefit from the same system
Exclusion Criteria:
* Prior therapy with PD-1/PD-L1 ICI or VEGFR-TKI monotherapy.
* Poorly controlled hypertension despite antihypertensive therapy
* More than one adverse prognostic factor (IMDC criteria)
* Women who are pregnant or lactating;
* Current participation in an investigational program
* Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
* Adults who are the subject of legal protection measures
* Persons deprived of their liberty by a judicial or administrative decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05219318
Study Brief:
Protocol Section:
NCT05219318