Cutaneous Basal Cell Carcinoma
Conditions
Brief summary
Phase Ib: ● The primary endpoint is the incidence of adverse events (AE) and treatment-related AEs (TRAEs) assessed by NCI CTCAE v5.0 (Appendix 5)., Phase II: ● The primary endpoint RFS rate at 3 years, defined as the proportion of patients free of locoregional progression or recurrence, distant metastasis (RECIST v 1.1; Appendix 3) or death due to any cause at 3-years from the date of study treatment initiation.
Detailed description
Phase Ib: ● Pathological response assessment: proportion of patients with pathologic complete response (pCR) per Immune-Related Pathologic Response Criteria' (irPRC) criteria (Appendix 4): 0% residual viable tumor (RVT) remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery., Objective response rate (ORR), Clinical benefit rate (CBR), Duration of clinical benefit (DBC), Relapse-free survival (RFS), Overall survival (OS), Phase II: ● Pathologic complete response (pCR), Objective response rate (ORR), Clinical benefit rate (CBR), Duration of clinical benefit (DBC), Rate of resectability, downstaging, Overall survival (OS), Adverse events (AE), Treatment-related AEs (TRAEs)
Interventions
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGIMUNOCARE 5% crema
Sponsors
Instituto Oncologico Dr. Rosell S.L.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Phase Ib: ● Pathological response assessment: proportion of patients with pathologic complete response (pCR) per Immune-Related Pathologic Response Criteria' (irPRC) criteria (Appendix 4): 0% residual viable tumor (RVT) remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery., Objective response rate (ORR), Clinical benefit rate (CBR), Duration of clinical benefit (DBC), Relapse-free survival (RFS), Overall survival (OS), Phase II: ● Pathologic complete response (pCR), Objective response rate (ORR), Clinical benefit rate (CBR), Duration of clinical benefit (DBC), Rate of resectability, downstaging, Overall survival (OS), Adverse events (AE), Treatment-related AEs (TRAEs) | — |
Primary
| Measure | Time frame |
|---|---|
| Phase Ib: ● The primary endpoint is the incidence of adverse events (AE) and treatment-related AEs (TRAEs) assessed by NCI CTCAE v5.0 (Appendix 5)., Phase II: ● The primary endpoint RFS rate at 3 years, defined as the proportion of patients free of locoregional progression or recurrence, distant metastasis (RECIST v 1.1; Appendix 3) or death due to any cause at 3-years from the date of study treatment initiation. | — |
Countries
Spain
Outcome results
None listed