WHO ICTRP trial
Treatment pause versus treatment continuation in good or intermediate risk with…
CTIS2024-514644-93-00 · EU Clinical Trials Information System · Recruiting
Key facts
| Trial ID | CTIS2024-514644-93-00 |
|---|---|
| Public title | 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 |
| Scientific title | Strategic treatment Pause of first-line Immune Check point inhibitor + Inhibitor in good or only one adverse prognostic factor in intermediate risk metastatic renal cell carcinoma (mRCC) with an objective response: a randomized, non-inferiority phase III study - SPICI - CHUBX 2021/08 |
| Primary sponsor | Centre Hospitalier Universitaire De Bordeaux |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | France |
| Conditions | Metastatic renal cell carcinoma (mRCC) with a good or only one adverse prognostic factor intermediate risk per IMDC score MedDRA version: 27.0Level: PTClassification code: 10050513Term: Metastatic renal cell carcinoma Class… |
| Interventions | Product Name: Inlyta 5 mg film-coated tablets, Product Code:PRD6540033, Pharmaceutical Form: FILM-COATED TABLET, Other descriptive name: , Strength: , Product Name: KEYTRUDA 25 mg/mL concentrate for solution for infusion, Product… |
| Registration date | Sep 7, 2024 |
| Target size | 372 |
| Secondary IDs | NCT05219318;2021-003447-25 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: