Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05219318 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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
StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-23
View on ClinicalTrials.gov ↗

Amendment history

2025-06-03
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-01→2027-01
Completion date2025-01→2027-01
Enrollment targetestimated 372→confirmed 22
Study sites27→26
2024-07-02
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v3
Primary completion date2024-01→2025-01
Eligibility criteria+101 characters
[...] ose with no period of discontinuation > 6 consecutive weeks induring thetreatment last 12 months forof the PD-1/PD-L1 ICI, and 2 consecutive weeks in the last 3 m [...] objective response (complete response or partial response) afterbetween 12the monthsend of 11th month and the end of the 13th month of the combination treatment with PD-1/PD-L1 ICI and VEGFR- [...] ≥ 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 m [...] system or b [...]
Study description+6 characters
[...] nts with a better outcome. Patient will be randomised after 1211 to 13 months of treatment with PD-1/PD-L1 ICI plus VEGFR-TKI (tre [...]
Study sitesdetails revised at 24 of 27 sites
2023-03-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-10→2024-01
Completion date2024-10→2025-01
Start dateestimated 2022-10→confirmed 2023-01-23
Study sites25→27
2022-08-10
Study Status, Outcome Measures, Contacts/Locations v1
Primary completion date2023-06→2023-10
Completion date2024-06→2024-10
Start date2022-06→2022-10
Study sites27→25
Secondary endpointsdetails revised at 1 of 10 entries
2022-01-20
Original filing
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.
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