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A

Indication details

Control Arm
Placebo
Therapeutic Indication
Adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.
Tumour Type
Skin Cancers
Tumour Sub-type
Cutaneous Melanoma
Tumour Stage
Adjuvant
Trial Name
CHECKMATE-76K
NCT Number
NCT04099251
Trial Phase
Phase III

Approval details

FDA Approval
FDA approval October 2023

Primary Outcome(s)

Primary Outcome(s)
RFS
Evaluated Outcome
RFS
Form(s)
Form 1

Outcome Data

OS Control
OS not reported (immature)
RFS Control
12 months 79.4%
RFS Gain
9.60%
RFS HR
0.42 (0.30-0.59)

Adjustments

QoL Comment
Not qualified for an ESMO-MCBS credit

Score (after adjustments)

Curative score

A

Scorecard details

ESMO-MCBS version
ESMO-MCBS v1.1
Scorecard ID
403
Scorecard version
1
Issue date
20.11.2023
Nivolumab CHECKMATE-76K

PRELIMINARY SCORE

RFS

ADJUSTMENTS

Not qualified for an ESMO-MCBS credit
Nivolumab CHECKMATE-76K

SCORE

A

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 completely resected Stage IIB/C melanoma in patients 12 years and older.
Nivolumab
Placebo

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