3
Indication details
- Control Arm
- Subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF)
- FDA Therapeutic Indication
- EMA: Indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. FDA: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Unresectable that is regionally or distantly metastatic
- Trial Name
- OPTiM
- NCT Number
- NCT00769704
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval October 2015
- EMA Approval
- EMA (CHMP) October 2015 EC decision December 2015
Primary Outcome(s)
- Primary Outcome(s)
- DRR (lasting continuously 6 months) per independent assessment
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 18.9 months
- OS Gain
- 4.4 months
- OS HR
- 0.79 (0.62-1.00), p=0.0494
- RR Gain
- 6 month durable response rate 2.1%
- ORR
- DRR gain 14.2%
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 378
- Scorecard version
- 1
- Issue date
- 08.05.2023
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.