1
Indication details
- Control Arm
- Single arm
- Therapeutic Indication
- Recurrent or metastatic SCCHN with disease progression on or after platinum-containing ChT
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Squamous cell
- Tumour Stage
- Recurrent or metastatic second line
- Trial Name
- KEYNOTE-012
- NCT Number
- NCT01848834
- Trial Phase
- Phase I
Approval details
- FDA Approval
- FDA approval August 2016
- EMA Approval
- EMA approved
- Comment
- EMA approval is for PD-L1 TPS ≥50%
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- PFS
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 2 months
- ORR
- 18%
- DoR
- Not reached
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
1
- Non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 387
- Scorecard version
- 1
- Issue date
- 07.08.2023
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.