A
4
Indication details
- Combined Agent(s)
- Dacarbazine
- Control Arm
- Dacarbazine + placebo
- Therapeutic Indication
- Advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (Basis of EMA and FDA approval of 1st-line ipilimumab monotherapy)
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced unresectable or metastatic
- Trial Name
- CA184-024
- NCT Number
- NCT00324155
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a / Form 1
Outcome Data
- OS Control
- 9.1 months 17.8 % at 2-years 8.8% at 5 years
- OS Gain
- 2.1 months 11.1% at 2-years 9.4% at 5 years
- OS HR
- 0.69 (0.57-0.84)
Adjustments
- QoL Comment
-
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
- 90
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 16.01.2023
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.