A
4
Indication details
- Control Arm
- Ipilimumab
- 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 and OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- PFS Control
- 2.9 months
- PFS Gain
- 4 months
- PFS HR
- 0.53 (0.44-0.64)
- OS Control
- 19.9 months 6.5 years 23%
- OS Gain
- 17.0 months 6.5 years 19% (with plateau)
- OS HR
- 0.63 (0.52-0.76)
Adjustments
- QoL Comment
-
No QoL benefit
Final Score (after adjustments)
- Preliminary non-curative score
-
4
- Long-term plateau in the survival curve
- There is a long term plateau in the survival curve, and OS advantage continues to be observed at 5 years has also been scored according to form 1 (treatments with curative potential).
- Final non-curative score
-
4
- Final 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
- 04.05.2023
Legend
Information about symbols, abbrevations and color codes
- 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
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include: