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A Phase III Randomized Controlled Multicentre Trial of Percutaneous Hepatic Perfusion in Combination with Ipilimumab and Nivolumab Compared to Ipilimumab and Nivolumab Only in Patients with Uveal Melanoma Liver Metastases – the SCANDIUM III trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508156-20-00
Enrollment
40
Registered
2024-04-24
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma Liver Metastases

Brief summary

Progression-free survival (PFS)

Detailed description

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), Objective response rate (ORR), Clinical benefit rate (CBR), Hepatic progression-free survival (hPFS), Extrahepatic progression-free survival (xhPFS), Overall survival (OS), Melanoma-specific survival (MSS), Duration of response (DOR), Quality of Life (QoL), ctDNA zero-conversion rate at 24 weeks, Predictive and prognostic biomarker discovery

Interventions

DRUGlösning
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGYERVOY 5 mg/ml concentrate for solution for infusion

Sponsors

Vaestra Goetalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)

Secondary

MeasureTime frame
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), Objective response rate (ORR), Clinical benefit rate (CBR), Hepatic progression-free survival (hPFS), Extrahepatic progression-free survival (xhPFS), Overall survival (OS), Melanoma-specific survival (MSS), Duration of response (DOR), Quality of Life (QoL), ctDNA zero-conversion rate at 24 weeks, Predictive and prognostic biomarker discovery

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026