Advanced basal cell carcinoma not amenable to local therapy or after progression on at least one line of systemic therapy Advanced squamous cell carcinoma (basosquamous/metatypicus type) or other skin cancers not amenable to local therapy
Conditions
Brief summary
Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) as determined by the investigator according to criteria –RECIST 1.1
Detailed description
Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) on two consecutive examinations >= 4 weeks apart, as determined by the investigator according to criteria ir - RECIST, Duration of Response (DoR), Progression free/Overall survival rate at 12 and 24 month, Incidence of and severity of AEs according to scale NCI CTCAE v 5.0. Changes in vital signs, physical findings, ECG/ECHO parameters, and clinical laboratory results, Change from day 1 in patient-reported outcomes (QLQ): : QLQ-C30, EQ-5D-3L, FACT-ICM, In patients +65 year old, Comprehensive Geriatric Assessment (CGA) will be performed at screening (SCR) and end of treatment (EOT)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) as determined by the investigator according to criteria –RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (CBR), defined as a stable disease (SD; partial response (PR) or complete response (CR) on two consecutive examinations >= 4 weeks apart, as determined by the investigator according to criteria ir - RECIST, Duration of Response (DoR), Progression free/Overall survival rate at 12 and 24 month, Incidence of and severity of AEs according to scale NCI CTCAE v 5.0. Changes in vital signs, physical findings, ECG/ECHO parameters, and clinical laboratory results, Change from day 1 in patient-reported outcomes (QLQ): : QLQ-C30, EQ-5D-3L, FACT-ICM, In patients +65 year old, Comprehensive Geriatric Assessment (CGA) will be performed at screening (SCR) and end of treatment (EOT) | — |
Countries
Poland