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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
Nivolumab CheckMate 238

PRELIMINARY SCORE

NEB

ADJUSTMENTS

?
QoL data pending
Nivolumab CheckMate 238

SCORE

NEB
Overall Survival / Disease-Free Survival / Pathological Complete Response
Overall Survival
Progression-Free Survival
Non-inferiority (Improved Quality of Life or Reduced Adverse Events) / Response Rate
Overall Response Rate / Duration of Response
Skin Cancers
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
Nivolumab
Ipilimumab 10mg/kg

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