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Comparing treatment pause to treatment continuation for certain kidney cancer patients

SPICI: Strategic Treatment Pause of First-line Immune Check Point Inhibitor + VEGFR-Tyrosine Kinase Inhibitor in Good or Only One Adverse Prognostic Factor in Intermediate Risk Metastatic Renal Cell Carcinoma (mRCC) With an Objective Response: a Randomised, Non-inferiority Phase III Study

Phase 3 Interventional University Hospital, Bordeaux · NCT05219318

This study is testing whether taking a break from treatment is just as effective as continuing it for kidney cancer patients who have responded well after about a year of therapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment372 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Bordeaux Academic / other
Drugs / interventionsradiation
Locations27 sites (Bayonne and 26 other locations)
Trial IDNCT05219318 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate whether pausing treatment is as effective as continuing treatment for patients with metastatic renal cell carcinoma (mRCC) who have shown an objective response after 11 to 13 months of therapy with PD-1/PD-L1 inhibitors and VEGFR-TKIs. Patients will be randomized to either continue their treatment or take a treatment pause, and their tolerance, quality of life, and healthcare resource utilization will be assessed over a follow-up period. The study specifically targets patients classified as good or intermediate risk with only one adverse prognostic factor according to IMDC criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic renal cell carcinoma who have had an objective response to prior treatment.

Not a fit: Patients with multiple adverse prognostic factors or those not responding to initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing treatment strategies for mRCC patients, potentially improving their quality of life and reducing healthcare costs.

How similar studies have performed: While the combination of PD-1/PD-L1 inhibitors and VEGFR-TKIs has shown success in treating mRCC, the specific approach of treatment pause versus continuation is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Bayonne and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Renal Cell CarcinomaGood or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC ScoreMetastatic renal cell carcinomaObjective responseTreatment pauseTreatment continuation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.