3
ESMO-MCBS v1.1
Scorecard version: 1
Indication details
- Tumour Type
- Skin Cancers
- Tumour Sub-type
- Cutaneous Squamous Cell Carcinoma
- Tumour stage
- Recurrent or metastatic
- Control Arm
- Single arm (Phase II)
- Treatment Setting
- For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
- Trial Name
- KEYNOTE-629
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- DoR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 5.7 months
- ORR
- 35.2%
- DoR
- >9 months
- QoL Comment
- Exploratory data only suggest improvement
Final Score (after adjustments)
- Final non-curative Score
- 3
- Comment
- FDA approval June 2020
- Issue date
- 22.11.2022
- Release date
- 22.11.2022
ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response/remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression