2
Indication details
- Combined Agent(s)
- Cisplatin-based ChT (Gemcitabine+Cisplatin)
- Control Arm
- Standard of care chemotherapy (Gemcitabine+Cisplatin)
- FDA Therapeutic Indication
- Nivolumab in combination with cisplatin-based chemotherapy in the first-line setting for the treatment of patients with unresectable or metastatic urothelial carcinoma
- Tumour Type
-
Genitourinary Cancers
- Tumour Sub-type
- Urothelial Carcinoma
- Tumour Stage
- Unresectable or metastatic
- Trial Name
- CHECKMATE-901
- NCT Number
- NCT03036098
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval March 2024
- EMA Approval
- EMA (CHMP) April 2024. Pending EC decision (recommendations on extensions)
Primary Outcome(s)
- Primary Outcome(s)
- PFS, OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 7.6 months
- PFS Gain
- 0.3 months
- PFS HR
- 0.72 (0.59-0.88)
- OS Control
- 18.9 months
- OS Gain
- 2.8 months
- OS HR
- 0.78 (0.63-0.96)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Preliminary non-curative score
-
2
- Non-curative score
-
2
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 416
- Scorecard version
- 1
- Issue date
- 16.01.2024
- Last update
- 29.04.2024
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.