5
Indication details
- Control Arm
- Investigator choice (methotrexate or cetuximab or docetaxel)
- FDA Therapeutic Indication
- As monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Squamous cell
- Tumour Stage
- Recurrent or metastatic
- Trial Name
- CheckMate141
- NCT Number
- NCT02105636
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval November 2016
- EMA Approval
- EMA (March 2017) EC decision May 2017
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 5.1 months 2-year OS: 6.0%
- OS Gain
- 2.6 months 2-year OS gain: 10.9%
- OS HR
- 0.68 (0.54-0.86)
Adjustments
- QoL Comment
-
QoL evaluated as exploratory end point (as distinct from primary or secondary) is not eligible for ESMO-MCBS grading
- Toxicity Comment
-
Reduced toxicity
Score (after adjustments)
- Preliminary non-curative score
-
4
- Toxicity adjustment
- 1+
- Non-curative score
-
5
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 189
- Scorecard version
- 1
- Issue date
- 15.07.2020
- Last update
- 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.