3
Indication details
- Control Arm
- Sorafenib
- Therapeutic Indication
- Adult patients with relapsed or refractory advanced RCC following ≥2 prior systemic therapies
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Renal cell cancer
- Tumour Stage
- Relapsed or refractory advanced
- Trial Name
- TIVO-3
- NCT Number
- NCT02627963
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2021
Primary Outcome(s)
- Primary Outcome(s)
- PFS ITT
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 3.9 months
- PFS Gain
- 1.7 months
- PFS HR
- 0.73 (0.56-0.94)
- OS Gain
- 16.4 months
- OS HR
- 0.99 (0.76-1.29) Not significant (immature)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
FDA approval March 2021
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 268
- Scorecard version
- 1
- Issue date
- 22.04.2021
- 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.