NEB
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- In combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Adjuvant
- Tumour Sub-Group
- BRAF V600
- Trial Name
- COMBI-AD
- NCT Number
- NCT01682083
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) July 2018 EC decision September 2018
- Comment
- In post hoc unplanned analysis survival advantage was restricted to patients with BRAF V600E mutation HR 0.75 (0.58–0.96), and among patients with V600K mutation there is a deleterious effect on OS HR 1.95 (0.84–4.50)
Primary Outcome(s)
- Primary Outcome(s)
- RFS
- Evaluated Outcome
- RFS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 8-year 65%
- OS Gain
- 8-year 6%
- OS HR
- 0.80 (0.62-1.01) P=0.06
- RFS Control
- 16.6 months
- RFS Gain
- 76.5 months
- RFS HR
- 0.52 (0.43-0.63)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
- Toxicity Comment
-
≥25% discontinuation due to adverse effects
Score (after adjustments)
- Curative score
-
NEB
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 172
- Scorecard version
- 1
- Issue date
- 09.06.2020
- Last update
- 28.06.2024
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.