5
Indication details
- Control Arm
- Everolimus
- Therapeutic Indication
- As monotherapy for the treatment of advanced renal cell carcinoma after prior therapy in adults
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- CheckMate025
- NCT Number
- NCT01668784
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2015
- EMA Approval
- EMA (CHMP) February 2016 EC decision April 2016
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 19.6 months
- OS Gain
- 5.4 months
- OS HR
- 0.73 (0.62-0.85)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
Reduced grade 3/4 adverse events 19% vs 37%
Score (after adjustments)
- Preliminary non-curative score
-
4
- QoL adjustment
- +1
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 103
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 16.05.2023
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.