Clinical Trial

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

Study acronym: SPICI
Active, Not Recruiting Phase 3
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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 between the end of the 11th month to th end of the 13th month 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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-01-20; most recent amendment 2025-06-03.
Status change: Recruiting → Active, Not Recruiting 2025-06-03
Status change: Not Yet Recruiting → Recruiting 2023-03-10
Trial Details
NCT Number NCT05219318
Lead Sponsor University Hospital, Bordeaux
Conditions Metastatic Renal Cell Carcinoma, Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score
Enrollment 22 participants
Start Date 2023-01-23
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-04