Status:
ACTIVE_NOT_RECRUITING
Treatment Pause Versus Treatment Continuation in IMDC Good or Intermediate Risk With Only One Adverse Prognostic Factor in mRCC Patients With an Objective Response at 12 Months of Treatment With PD1/ PDL1 ICIs + VEGFR-Tyrosine Kinase Inhibitors
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Metastatic Renal Cell Carcinoma
Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the non-inferiority of treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor as per IMDC mRCC p...
Detailed Description
Although multiple combinations therapies in particular PD-1/PD-L1 immune-checkpoint inhibitors (PD-1/PD-L1 ICIs) in combination with vascular endothelial growth factor receptor tyrosine kinase inhibit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05219318
Start Date
January 23 2023
End Date
January 1 2027
Last Update
June 4 2025
Active Locations (26)
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1
CH de la Cote Basque - Service d'Oncologie
Bayonne, France
2
CHU de Bordeaux - Service d'Oncologie
Bordeaux, France
3
Centre François Baclesse - Service d'Oncologie
Caen, France
4
Centre Jean Perrin - Service d'Oncologie
Clermont-Ferrand, France