4
Indication details
- Control Arm
- Single arm (Phase II)
- FDA Therapeutic Indication
- For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation
- Tumour Type
-
Skin Cancers
- Tumour Sub-type
- Cutaneous Squamous Cell Carcinoma
- Tumour Stage
- Locally advanced or metastatic
- Trial Name
- R2810-ONC-1423/R2810-ONC-1540
- NCT Number
- NCT02383212/NCT02760498
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval September 2018
- EMA Approval
- EMA (CHMP) April 2019 EC decision June 2019
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR, DOR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- Estimated median PFS of 18.4 months for all patients
- pCR Control
- 2-year: 44.2%
- ORR
- 46.1%
- DoR
- NR (95% CI 28.8 months-NE)
Adjustments
- QoL Comment
-
QoL improved
Score (after adjustments)
- Preliminary non-curative score
-
3
- QoL adjustment
- 1+
- Non-curative score
-
4
- Comment
-
EMA (CHMP) April 2019 EC decision June 2019
FDA approval September 2018
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 360
- Scorecard version
- 1
- Issue date
- 22.11.2022
- Last update
- 02.05.2024
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.