NEB
Indication details
- Control Arm
- Ipilimumab 10mg/kg
- Therapeutic Indication
- Adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Adjuvant
- Trial Name
- CheckMate 238
- NCT Number
- NCT02388906
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (June 2018) EC decision October 2018
- Comment
- EMA treatment setting updated in July 2023
Primary Outcome(s)
- Primary Outcome(s)
- RFS
- Evaluated Outcome
- RFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 5-year 72%
- OS Gain
- 5-years 4%
- OS HR
- 0.86 (0.66-1.12) Not significant
- RFS Control
- 24.1 months 5-year 39%
- RFS Gain
- 36.9 months 5-year 11%
- RFS HR
- 0.72 (0.60-0.86)
Adjustments
- QoL Comment
-
QoL data pending
- Toxicity Comment
-
Fewer treatment-related grade 3 or 4 AEs: 14.4% versus 45.9%
Fewer treatment discontinuation due to treatment-related AEs: 7.7% versus 41.7%
Score (after adjustments)
- Curative score
-
NEB
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 174
- Scorecard version
- 1
- Issue date
- 09.06.2020
- Last update
- 28.06.2024