A
4
Indication details
- Control Arm
- Ipilimumab
- Therapeutic Indication
- Ipilimumab in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older*
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced
- Trial Name
- CheckMate 067
- NCT Number
- NCT01844505
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) April 2016 EC decision June 2016
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
- 8.6 months
- PFS HR
- 0.42 (0.35-0.51)
- OS Control
- 19.9 months 6.5 years 23%
- OS Gain
- 52.2 months 6.5 years 26% (with plateau)
- OS HR
- 0.52 (0.43-0.64)
Adjustments
- QoL Comment
-
No QoL benefit
- Toxicity Comment
-
Higher toxicity and discontinuation rate
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, and increase in PFS and OS for the combination of nivolumab with ipilimumab is establishes only in patients with low tumour PD-L1 expression.
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 77
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 05.06.2023
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.