3
Indication details
- Control Arm
- Investigator-choice chemotherapy (Randomised phase II study)
- Therapeutic Indication
- Adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Melanoma
- Tumour Stage
- Advanced unresectable or metastatic
- Trial Name
- KEYNOTE-002
- NCT Number
- NCT01704287
- Trial Phase
- Phase II
Primary Outcome(s)
- Primary Outcome(s)
- PFS 2 mg/kg
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 2.7 months
- PFS Gain
- 0.2 months
- PFS HR
- 0.57 (0.45-0.73) plateau PFS gain >10% at 1 year
Adjustments
- QoL Comment
-
Not qualified for an ESMO-MCBS credit
Score (after adjustments)
- Preliminary non-curative score
-
2
- Long-term plateau in the PFS curve
- 1+
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 91
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 16.01.2023