3
Indication details
- Control Arm
- Single arm
- Therapeutic Indication
- A liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Uveal melanoma
- Tumour Stage
- Unresectable metastatic
- Trial Name
- FOCUS
- NCT Number
- NCT02678572
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2023
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 9 months
- OS Control
- 20.5 months
- ORR
- 36.30%
- DoR
- 14 months
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 447
- Scorecard version
- 1
- Issue date
- 20.06.2024