A
4
Indication details
- Control Arm
- Dacarbazine
- Therapeutic Indication
- As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced unresectable or metastatic
- Trial Name
- CheckMate 066
- NCT Number
- NCT01721772
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- PFS Control
- 2.2 months
- PFS Gain
- 2.9 months
- PFS HR
- 0.43 (0.34-0.56)
- OS Control
- 11.2 months 5-years 17%
- OS Gain
- 26.1 months 5-years 22%
- OS HR
- 0.50 (0.40-0.63)
Adjustments
- QoL Comment
-
Reviewed, but not qualified for an ESMO-MCBS credit
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)
- Non-curative score
-
4
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 89
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 26.03.2024
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.