Clinical trial
Treatment Pause Versus Treatment Continuation in IMDC Good or Intermediate Risk…
NCT05219318 · University Hospital, Bordeaux, Other · Active, not recruiting
Key facts
| NCT number | NCT05219318 |
|---|---|
| Title | 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 |
| Official title | 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 |
| Acronym | SPICI |
| Lead sponsor | University Hospital, Bordeaux, Other |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Metastatic Renal Cell Carcinoma, Good or Only One Adverse Prognostic Factor Intermediate Risk Per IMDC Score |
| Intervention type | Drug, Other |
| Interventions | Combination PD-1/PD-L1 ICI + VEGFR-TKI, Treatment pause |
| Enrollment | 22 |
| Start date | Jan 23, 2023 |
| Primary completion | Jan 1, 2027 |
| Completion | Jan 1, 2027 |
| First posted | Feb 2, 2022 |
| Last update posted | Jun 4, 2025 |
| Countries | France |
At a glance
- 10–99 Study sites
- No Results posted
- 1–9 FDA inspections linked to this trial
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: