A
Indication details
- Control Arm
- Placebo
- FDA 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)
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
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.