4
Indication details
- Control Arm
- Dacarbazine
- FDA Therapeutic Indication
- As monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Metastatic
- Tumour Sub-Group
- BRAF V600K
- Trial Name
- BRIM-3
- NCT Number
- NCT01006980
- Trial Phase
- Phase III
Approval details
- EMA Approval
- EMA (CHMP) December 2011 EC decision February 2012
Primary Outcome(s)
- Primary Outcome(s)
- PFS and OS
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 1.6 months
- PFS Gain
- 5.3 months
- PFS HR
- 0.38 (0.32-0.46)
- OS Control
- Longer follow-up: 9.7 months
- OS Gain
- Longer follow-up: 3.9 months
- OS HR
- OS significant at interim with 63% reduction in death. Longer follow-up: 0.81 (0.67-0.98)
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- Upgrade for early stopping based on interim analysis of OS
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 83
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 31.07.2024
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.