A
4
Indication details
- Control Arm
- Ipilimumab
- FDA Therapeutic Indication
- Monotherapy for the treatment of advanced melanoma in adults and adolescents 12 years of age and older*
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced unresectable or metastatic
- Trial Name
- CheckMate 067
- NCT Number
- NCT01844505
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) April 2015 EC decision June 2015
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- OS Control
- 19.9 months 10-year OS: 19%
- OS Gain
- 17.0 months 10-year OS gain: 18% (with plateau)
- OS HR
- 0.63 (0.52-0.76)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
4
- Non-curative score
-
4
- Curative score
-
A
- Comment
-
* Relative to nivolumab monotherapy, an increase in progression‑free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD‑L1 expression.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 78
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 20.11.2024
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.