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 (CHMP) 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). Five-year data account for 75% of the expected events. Mature OS data
- 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
- Comment
-
For stage III melanoma, 5 years confers adequate maturity, and thus, OS data can be considered mature.
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
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.