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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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 patients with a confirmed objective response at 12 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI.

Tolerance and quality of life of treatment pause with PD-1/PD-L1 ICI + VEGFR-TKI compared to treatment continuation will be reported. In France, its impact on healthcare resource utilization will also be assessed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux

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 in the last 12 months for 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) after 12 months 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

• 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:

• Any active central nervous system (CNS) metastases

• 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