4
Indication details
- Combined Agent(s)
- Pembrolizumab
- Control Arm
- Sunitinib
- Therapeutic Indication
- Treatment of adults with advanced renal cell carcinoma in combination with pembrolizumab as first-line treatment
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Advanced
- Trial Name
- CLEAR
- NCT Number
- NCT02811861
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval August 2021
- EMA Approval
- EMA (CHMP) October 2021 EC decision November 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS/OS (hierarchically)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 9.2 months
- PFS Gain
- 14.7 months
- PFS HR
- 0.39 ( 0.32-0.49)
- OS Control
- 2-years 70.4%
- OS Gain
- 2-years 8.8%
- OS HR
- 0.66 (0.49- 0.88); P = 0.005 <0.016 for early stopping
Adjustments
- QoL Comment
-
Improved QoL
Score (after adjustments)
- Preliminary non-curative score
-
3
- Early stopping or crossover
- 1+
- Non-curative score
-
4
- Comment
-
Score derived from form 2b criteria with an upgrade for early stopping based on OS advantage detected with both OS medians not reached.
Benefit may be exaggerated by low prevalence of subsequent immunotherapy in patients progressing in the control arm, indicating substandard post-progression therapy.
EMA (CHMP) October 2021 EC decision November 2021
FDA approval August 2021
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 284
- Scorecard version
- 1
- Issue date
- 27.08.2021
- Last update
- 15.05.2023
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.