BridgeMD
Treatment pause versus treatment continuation in good or intermediate risk with only one adverse prognostic factor in mRCC patients that has achieved an objective response at 12 months of treatment with PD-1/ PDL1 ICIs + VEGFR-Tyrosine Kinase Inhibitors (TKI) - SPICI
EU CTIS ID: 2024-514644-93-00
What this study is testing
To assess the non-inferiority of treatment pause compared to treatment continuation with PD-1/ PDL-L1 ICIs + VEGFR-Tyrosine Kinase inhibitor in an IMDC good risk or only one adverse prognostic factor intermediate risk mRCC population that has achieved an objective response between the end of the 11th month and the end of the 13th of treatment with the combination regimens
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years at time of signing informed consent form
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years at time of signing informed consent form
- 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
- 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 the 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.